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2026-10-23 15:52 1d ago
2026-10-23 11:01 1d ago
Regeneron (REGN) Earnings Expected to Grow: What to Know Ahead of Next Week's Release
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
The market expects Regeneron (REGN - Free Report) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.

The earnings report, which is expected to be released on October 30, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.

While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise.

Zacks Consensus EstimateThis biopharmaceutical company is expected to post quarterly earnings of $16.08 per share in its upcoming report, which represents a year-over-year change of +35.9%.

Revenues are expected to be $4.55 billion, up 21.2% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 36.31% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Regeneron?For Regeneron, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -1.12%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination makes it difficult to conclusively predict that Regeneron will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Regeneron would post earnings of $10 per share when it actually produced earnings of $14.29, delivering a surprise of +42.90%.

Over the last four quarters, the company has beaten consensus EPS estimates four times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Regeneron doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Expected Results of an Industry PlayerAnother stock from the Zacks Medical - Biomedical and Genetics industry, LENZ Therapeutics, Inc. (LENZ - Free Report) , is soon expected to post loss of $0.99 per share for the quarter ended September 2026. This estimate indicates a year-over-year change of -67.8%. Revenues for the quarter are expected to be $4.01 million, down 67.9% from the year-ago quarter.

The consensus EPS estimate for LENZ Therapeutics, Inc. has been revised 2.2% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +2.79%.

This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that LENZ Therapeutics, Inc. will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
2026-10-22 15:01 2d ago
2026-10-22 09:45 2d ago
Regeneron: Is The Market Undervaluing Its Growth Potential
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
SummaryAt the end of October, Regeneron Pharmaceuticals, Inc. will report its results for Q3.As a reminder, REGN's Q2 revenue rose 18.8% quarter-on-quarter and 16.6% YoY to $4.29 billion, primarily due to the strong performance of Dupixent.On October 12, Regeneron reported positive Phase 3 OPTIMA results, demonstrating sustained Pasatru efficacy in reducing new HO lesions and disease flare-ups in people with FOP.Meanwhile, REGN trades at just 13.8x forward non-GAAP P/E, versus the sector median of 19.5x.In this article, I'll explain why Regeneron Pharmaceuticals offers an appealing risk/reward profile. Klaus Vedfelt/DigitalVision via Getty Images

Following my August article, "Regeneron: Why I Still See Upside After The Rally," which focused primarily on the anti-PD-1 mAb Opdivo and the blockbuster, called Dupixent, Regeneron Pharmaceuticals, Inc.'s (

3.65K Followers

Analyst’s Disclosure: I/we have a beneficial long position in the shares of ALVO either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.
2026-10-19 14:53 5d ago
2026-10-19 04:48 5d ago
Frank Rimerman Advisors LLC Acquires 876 Shares of Regeneron Pharmaceuticals, Inc. $REGN
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Frank Rimerman Advisors LLC lifted its holdings in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Free Report) by 153.7% in the 3rd quarter, according to its most recent 13F filing with the SEC. The firm owned 1,446 shares of the biopharmaceutical company’s stock after purchasing an additional 876 shares during the quarter. Frank Rimerman Advisors LLC’s holdings in Regeneron Pharmaceuticals were worth $1,096,000 as of its most recent SEC filing.

A number of other large investors have also bought and sold shares of the business. BlackRock Inc. bought a new position in Regeneron Pharmaceuticals in the second quarter valued at approximately $5,682,636,000. State Street Corp boosted its holdings in shares of Regeneron Pharmaceuticals by 3.6% in the second quarter. State Street Corp now owns 4,834,688 shares of the biopharmaceutical company’s stock valued at $3,014,621,000 after buying an additional 170,210 shares during the period. Bank of America Corp DE boosted its holdings in shares of Regeneron Pharmaceuticals by 2.8% in the first quarter. Bank of America Corp DE now owns 1,189,584 shares of the biopharmaceutical company’s stock valued at $919,120,000 after buying an additional 32,158 shares during the period. Amundi increased its position in shares of Regeneron Pharmaceuticals by 27.5% during the first quarter. Amundi now owns 1,009,798 shares of the biopharmaceutical company’s stock worth $780,210,000 after acquiring an additional 217,892 shares in the last quarter. Finally, Legal & General Group Plc bought a new stake in shares of Regeneron Pharmaceuticals during the second quarter worth $473,872,000. 83.31% of the stock is owned by institutional investors.

Regeneron Pharmaceuticals Stock Performance NASDAQ:REGN opened at $790.74 on Monday. The company has a market cap of $81.41 billion, a P/E ratio of 19.54, a price-to-earnings-growth ratio of 1.37 and a beta of 0.16. Regeneron Pharmaceuticals, Inc. has a twelve month low of $566.11 and a twelve month high of $859.34. The business has a 50 day moving average price of $791.72 and a two-hundred day moving average price of $721.59. The company has a quick ratio of 2.78, a current ratio of 3.34 and a debt-to-equity ratio of 0.06.

Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) last posted its quarterly earnings data on Thursday, July 30th. The biopharmaceutical company reported $14.29 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of $10.16 by $4.13. Regeneron Pharmaceuticals had a net margin of 27.86% and a return on equity of 13.47%. The company had revenue of $4.29 billion for the quarter, compared to the consensus estimate of $3.82 billion. During the same period last year, the company earned $12.81 earnings per share. The firm’s revenue was up 16.7% compared to the same quarter last year. As a group, analysts expect that Regeneron Pharmaceuticals, Inc. will post 47.93 EPS for the current fiscal year. Regeneron Pharmaceuticals Dividend Announcement The firm also recently announced a quarterly dividend, which was paid on Monday, August 31st. Investors of record on Tuesday, August 18th were issued a dividend of $0.94 per share. The ex-dividend date was Tuesday, August 18th. This represents a $3.76 annualized dividend and a yield of 0.5%. Regeneron Pharmaceuticals’s dividend payout ratio is presently 9.29%.

Here are the key news stories impacting Regeneron Pharmaceuticals this week:

Positive Sentiment: Strong quarterly performance supported the bullish case. Regeneron reported second-quarter revenue of $4.29 billion, up 16.7% year over year and above analyst expectations. Earnings per share of $14.29 also exceeded the $10.16 consensus estimate, reinforcing confidence in the company’s earnings momentum. Regeneron earnings and investment narrative Positive Sentiment: Positive 84-week Phase 3 OPTIMA data for Pasatru in adults with fibrodysplasia ossificans progressiva indicated a sustained reduction in new heterotopic bone lesions and disease flare-ups, with a generally consistent safety profile. The results could strengthen confidence in the treatment’s commercial opportunity. Regeneron OPTIMA trial results Positive Sentiment: UBS upgraded REGN to Buy and raised its price target to $978 from $660, citing greater long-term potential for Dupixent and arguing that the market may be undervaluing the business. UBS Regeneron upgrade Positive Sentiment: Libtayo received a positive recommendation from the European Medicines Agency’s CHMP for a dosing regimen that could reduce administration frequency from every three weeks to every six weeks after the first 12 weeks, potentially improving convenience and market appeal. Final EU approval is still required. Libtayo CHMP recommendation Negative Sentiment: Insider Andrew Murphy sold 4,147 shares worth approximately $3.2 million. The transaction was made under a pre-arranged Rule 10b5-1 plan, limiting its significance, but it may contribute modestly to near-term caution. Regeneron insider sale filing Wall Street Analyst Weigh In A number of equities research analysts recently commented on REGN shares. Sanford C. Bernstein raised their price objective on shares of Regeneron Pharmaceuticals from $753.00 to $756.00 and gave the stock a “market perform” rating in a report on Friday, August 14th. Weiss Ratings reaffirmed a “hold (c)” rating on shares of Regeneron Pharmaceuticals in a research note on Monday, September 21st. The Goldman Sachs Group increased their target price on Regeneron Pharmaceuticals from $965.00 to $972.00 and gave the stock a “buy” rating in a report on Friday, July 31st. UBS Group upgraded Regeneron Pharmaceuticals from a “neutral” rating to a “buy” rating and increased their target price for the stock from $660.00 to $978.00 in a report on Thursday. Finally, Wells Fargo & Company lifted their price target on Regeneron Pharmaceuticals from $700.00 to $750.00 and gave the company an “equal weight” rating in a research note on Friday, July 31st. One investment analyst has rated the stock with a Strong Buy rating, twenty-two have issued a Buy rating and eight have issued a Hold rating to the company’s stock. Based on data from MarketBeat.com, Regeneron Pharmaceuticals presently has an average rating of “Moderate Buy” and an average target price of $845.21.

Check Out Our Latest Analysis on Regeneron Pharmaceuticals

Insider Buying and Selling at Regeneron Pharmaceuticals In other Regeneron Pharmaceuticals news, Director Kathryn Guarini sold 400 shares of Regeneron Pharmaceuticals stock in a transaction on Wednesday, September 2nd. The shares were sold at an average price of $850.00, for a total value of $340,000.00. Following the sale, the director directly owned 603 shares in the company, valued at approximately $512,550. The trade was a 39.88% decrease in their position. The sale was disclosed in a filing with the Securities & Exchange Commission, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Andrew J. Murphy sold 4,147 shares of the business’s stock in a transaction dated Wednesday, October 14th. The stock was sold at an average price of $772.70, for a total transaction of $3,204,386.90. Following the sale, the insider directly owned 47,833 shares in the company, valued at $36,960,559.10. This trade represents a 7.98% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last ninety days, insiders have sold 8,093 shares of company stock worth $6,506,845. Company insiders own 6.97% of the company’s stock.

About Regeneron Pharmaceuticals (Free Report)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses genetic and antibody-based research technologies to develop treatments in areas including eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease, infectious diseases and rare disorders.

Its marketed products include Eylea and Eylea HD for retinal diseases, Dupixent for several inflammatory and allergic conditions, Libtayo for certain cancers, Praluent for cardiovascular disease, Kevzara for rheumatoid arthritis, and other medicines such as Inmazeb, Evkeeza, Veopoz and Arcalyst.

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2026-10-19 14:53 5d ago
2026-10-19 10:24 5d ago
Forget Eli Lilly and Novo: This Biotech Could Be a Surprising Winner in the Weight Loss Market
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
The weight-loss market is growing rapidly, and while long-term projections differ on how large it will become, they generally agree that it will maintain its upward trajectory at least over the medium term. Investors can capitalize on this industry's growth by buying shares of those companies likely to emerge as top players. Right now, it looks likely that Eli Lilly (LLY -0.26%) and Novo (NVO -0.71%), the current market leaders, could maintain their lead over the next five years or so. However, other drugmakers are making progress in this field and are worth considering for investors. One of them is Regeneron Pharmaceuticals (REGN -0.26%).

Image source: The Motley Fool.

Regeneron's differentiated approachRegeneron has at least two promising weight loss medicines in its pipeline. One of them is called olatorepatide. Regeneron licensed this medicine from a China-based company. Olatorepatide mimics the actions of the GLP-1 and GIP hormones, placing it in the same broad category as Eli Lilly's market-leading drug, Zepbound.

However, olatorepatide could be particularly attractive for one reason: It appears to display better gastrointestinal (GI) tolerability than competing medicines. In a Phase 3 study conducted in China, olatorepatide led to a mean weight loss of up to 19% over 48 weeks. That's already impressive enough.

But as Regeneron pointed out, olatorepatide also had lower rates of GI-related adverse events -- such as nausea and vomiting -- than what some competing drugs achieved in comparable Phase 3 studies. Regeneron still has to run late-stage clinical trials in the U.S. before it can earn approval in the country.

However, olatorepatide's strong performance in Chinese studies makes it a notable contender in the weight loss market. Regeneron's other leading candidate is trevogrumab. This isn't a drug designed to induce weight loss. Rather, Regeneron is developing trevogrumab to be administered alongside anti-obesity medicines to help patients preserve lean mass as they lose weight.

In a Phase 2 study, trevogrumab, administered alongside Novo's semaglutide, led to lean mass preservation of up to 42.5% compared with just 7.3% in patients receiving semaglutide plus placebo. Trevogrumab is yet another differentiated product that could help Regeneron carve out a niche in the rapidly growing weight loss market.

REGN Regeneron Pharmaceuticals$788.66-$2.09 (-0.26%)

NASDAQ · As of 10:34 AM ET 10/19/26

More reasons to buy the stockOf course, there is much more to Regeneron's business than its weight loss candidates. The company's main growth driver, Dupixent, a medicine for eczema that it co-markets with Sanofi (SNY -1.60%), continues to perform well.

In the second quarter, Regeneron's revenue increased by 17% year over year to $4.3 billion. Dupixent's global sales (recorded by Sanofi) increased 38% year over year to $6 billion. It is helping Regeneron overcome biosimilar competition for Eylea, a medicine approved for several eye-related conditions, including wet age-related macular degeneration.

Regeneron's newer, higher-dose (HD) formulation of Eylea is helping keep the franchise afloat, at least somewhat. Second-quarter combined U.S. revenue from Eylea and Eylea HD declined 12% year over year to $1 billion. But HD Eylea's U.S. sales came in at $596 million, up 52% year over year.

The newer version of the drug comes with fewer injections per year. More convenient dosing can attract new patients while also prompting existing Eylea patients to switch. So, this franchise, despite recent struggles, isn't exactly dead in the water. Regeneron has other products that are contributing to sales growth, particularly Libtayo, a cancer medicine.

And the biotech boasts an attractive pipeline beyond its weight-loss products, including promising anticoagulants being developed to lower the bleeding risk associated with today's anticoagulants. Regeneron has underperformed the broader market over the past two years amid competition for Eylea, but the company is bouncing back, and, given its current approved lineup and pipeline, it could perform well over the medium term. The company's weight loss products may be a key part of the business within five years.
2026-10-18 14:19 6d ago
2026-10-18 04:09 6d ago
Insider Selling: Regeneron Pharmaceuticals (NASDAQ:REGN) Insider Sells $3,204,386.90 in Stock
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Get Free Report) insider Andrew Murphy sold 4,147 shares of the stock in a transaction that occurred on Wednesday, October 14th. The stock was sold at an average price of $772.70, for a total value of $3,204,386.90. Following the transaction, the insider owned 47,833 shares in the company, valued at approximately $36,960,559.10. This trade represents a 7.98% decrease in their position. The sale was disclosed in a document filed with the SEC, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Regeneron Pharmaceuticals Stock Performance NASDAQ:REGN opened at $790.74 on Friday. The stock has a market cap of $81.41 billion, a P/E ratio of 19.54, a PEG ratio of 1.37 and a beta of 0.16. The stock has a 50 day simple moving average of $791.72 and a 200 day simple moving average of $721.78. The company has a current ratio of 3.34, a quick ratio of 2.78 and a debt-to-equity ratio of 0.06. Regeneron Pharmaceuticals, Inc. has a 1-year low of $566.11 and a 1-year high of $859.34.

Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) last released its quarterly earnings results on Thursday, July 30th. The biopharmaceutical company reported $14.29 earnings per share (EPS) for the quarter, beating the consensus estimate of $10.16 by $4.13. Regeneron Pharmaceuticals had a return on equity of 13.47% and a net margin of 27.86%. The business had revenue of $4.29 billion during the quarter, compared to the consensus estimate of $3.82 billion. During the same period in the previous year, the company posted $12.81 EPS. The firm’s quarterly revenue was up 16.7% on a year-over-year basis. Research analysts anticipate that Regeneron Pharmaceuticals, Inc. will post 47.93 earnings per share for the current year.

Regeneron Pharmaceuticals Dividend Announcement The company also recently announced a quarterly dividend, which was paid on Monday, August 31st. Stockholders of record on Tuesday, August 18th were issued a dividend of $0.94 per share. The ex-dividend date of this dividend was Tuesday, August 18th. This represents a $3.76 dividend on an annualized basis and a dividend yield of 0.5%. Regeneron Pharmaceuticals’s dividend payout ratio (DPR) is currently 9.29%. Hedge Funds Weigh In On Regeneron Pharmaceuticals Hedge funds have recently added to or reduced their stakes in the stock. IFP Advisors Inc boosted its position in Regeneron Pharmaceuticals by 17.5% in the third quarter. IFP Advisors Inc now owns 1,588 shares of the biopharmaceutical company’s stock valued at $1,204,000 after buying an additional 236 shares in the last quarter. Robertson Stephens Wealth Management LLC bought a new stake in shares of Regeneron Pharmaceuticals during the third quarter worth $491,000. Frank Rimerman Advisors LLC increased its holdings in shares of Regeneron Pharmaceuticals by 153.7% during the third quarter. Frank Rimerman Advisors LLC now owns 1,446 shares of the biopharmaceutical company’s stock worth $1,096,000 after buying an additional 876 shares in the last quarter. Alpine Bank Wealth Management acquired a new position in shares of Regeneron Pharmaceuticals during the third quarter worth $34,000. Finally, USA Financial Formulas acquired a new position in shares of Regeneron Pharmaceuticals during the third quarter worth $743,000. Institutional investors own 83.31% of the company’s stock.

Analyst Ratings Changes Several research firms recently commented on REGN. Royal Bank Of Canada upped their price target on shares of Regeneron Pharmaceuticals from $737.00 to $810.00 and gave the company a “sector perform” rating in a research note on Thursday, October 8th. BMO Capital Markets raised their price target on shares of Regeneron Pharmaceuticals from $800.00 to $920.00 and gave the stock an “outperform” rating in a research report on Wednesday, September 9th. Raymond James Financial lifted their price objective on shares of Regeneron Pharmaceuticals from $902.00 to $911.00 and gave the stock an “outperform” rating in a research note on Friday, July 31st. JPMorgan Chase & Co. boosted their price objective on shares of Regeneron Pharmaceuticals from $900.00 to $950.00 and gave the company an “overweight” rating in a report on Tuesday, October 6th. Finally, Jefferies Financial Group boosted their price objective on shares of Regeneron Pharmaceuticals from $870.00 to $930.00 and gave the company a “buy” rating in a report on Thursday, October 1st. One research analyst has rated the stock with a Strong Buy rating, twenty-two have issued a Buy rating and eight have issued a Hold rating to the company. Based on data from MarketBeat.com, the company presently has an average rating of “Moderate Buy” and a consensus target price of $845.21.

Check Out Our Latest Stock Analysis on Regeneron Pharmaceuticals

Key Headlines Impacting Regeneron Pharmaceuticals Here are the key news stories impacting Regeneron Pharmaceuticals this week:

Positive Sentiment: Strong quarterly performance supported the bullish case. Regeneron reported second-quarter revenue of $4.29 billion, up 16.7% year over year and above analyst expectations. Earnings per share of $14.29 also exceeded the $10.16 consensus estimate, reinforcing confidence in the company’s earnings momentum. Regeneron earnings and investment narrative Positive Sentiment: Positive 84-week Phase 3 OPTIMA data for Pasatru in adults with fibrodysplasia ossificans progressiva indicated a sustained reduction in new heterotopic bone lesions and disease flare-ups, with a generally consistent safety profile. The results could strengthen confidence in the treatment’s commercial opportunity. Regeneron OPTIMA trial results Positive Sentiment: UBS upgraded REGN to Buy and raised its price target to $978 from $660, citing greater long-term potential for Dupixent and arguing that the market may be undervaluing the business. UBS Regeneron upgrade Positive Sentiment: Libtayo received a positive recommendation from the European Medicines Agency’s CHMP for a dosing regimen that could reduce administration frequency from every three weeks to every six weeks after the first 12 weeks, potentially improving convenience and market appeal. Final EU approval is still required. Libtayo CHMP recommendation Negative Sentiment: Insider Andrew Murphy sold 4,147 shares worth approximately $3.2 million. The transaction was made under a pre-arranged Rule 10b5-1 plan, limiting its significance, but it may contribute modestly to near-term caution. Regeneron insider sale filing (Get Free Report)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses genetic and antibody-based research technologies to develop treatments in areas including eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease, infectious diseases and rare disorders.

Its marketed products include Eylea and Eylea HD for retinal diseases, Dupixent for several inflammatory and allergic conditions, Libtayo for certain cancers, Praluent for cardiovascular disease, Kevzara for rheumatoid arthritis, and other medicines such as Inmazeb, Evkeeza, Veopoz and Arcalyst.

Read More Five stocks we like better than Regeneron Pharmaceuticals Rocket Lab’s Neutron Delay Leaves Wall Street Bullish But Raises the Stakes for 2027 ManpowerGroup Stock Sinks on Q3 Results, But Fundamentals Stay Solid Does the AI Selloff Put Alphabet’s Breakout in Doubt? Bank Earnings Are Mixed—These 2 ETFs Offer Very Different Paths to a Recovery

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2026-10-18 09:25 6d ago
2026-10-18 02:03 6d ago
Regeneron’s Murphy sells $3.2 million in stock under plan (NASDAQ: REGN)
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
What happened
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) said Co-Chief Scientific Officer Andrew J. Murphy sold 4,147 shares on 10/14/2026. The shares sold for $753.76 to $781.47 each and brought in about $3.20 million, according to the Form 4. The filing says the trades were made under a Rule 10b5-1 trading plan.

The same filing shows Murphy acquired 17,000 shares of common stock on 10/13/2026 at $381.92 through a non-qualified stock option. After these transactions, Murphy held 47,833 shares. The form also lists 4,414 shares held indirectly by a 401(k) Plan. The plan was adopted on May 7, 2026. The form was filed on 10/15/2026.

Key numbers

Metric
Latest
Change
Source

Shares sold
4,147 shares

SEC Form 4

Sale price range
from $753.76 to $781.47 per share

SEC Form 4

Sale value
about $3.20 million

SEC Form 4

Shares held after
47,833 shares

SEC Form 4

Option exercise
17,000 shares

SEC Form 4

Read more: Regeneron Pharmaceuticals (REGN) stock analysis and investment case
Why it matters
OptimistFi's case is that Regeneron converts a concentrated portfolio of approved biologics into durable free cash flow that funds R&D, buybacks and pipeline investment. This filing is mixed for that view because Murphy's 4,147-share sale was about 8.0% of the 51,980 shares held before the sale sequence. The option exercise added 17,000 shares at $381.92 before the sales.

The main offset is in the filing itself. The trades were made under a Rule 10b5-1 trading plan. Murphy still held 47,833 shares afterward, and the filing ties the plan to a May 7, 2026 adoption date. The reported sale prices and the 17,000-share option exercise show how the stake moved from 51,980 shares to 47,833 shares. That is the current baseline until the next quarterly report.

Browse: stock research on every company OptimistFi covers

What's next
Regeneron Pharmaceuticals, Inc.'s next quarterly report is the next scheduled test for the investment case. A stronger report would support the thesis on free cash flow, buybacks and pipeline investment. This Form 4 is a snapshot of one officer's trades and one option exercise, filed on 10/15/2026. The filing date is 10/15/2026, the same day Murphy signed the form. The reported sale prices and the exercise price give a clear benchmark for the stake in this filing.

More from OptimistFi

REGN stock: the Regeneron Pharmaceuticals thesis, its status and the next test to watch
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Sources

SEC Form 4 — Filed 10/15/2026

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2026-10-17 21:09 6d ago
2026-10-17 15:24 7d ago
Forget Eylea: Regeneron's Real Value May Be Hiding in Its Dupixent Profit Share
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals (REGN -0.70%) has underperformed broader equities over the past two years. Perhaps the biggest reason for that is the company's declining sales of Eylea, a medicine that treats several eye-related conditions. Regeneron has faced significant competition (biosimilar and otherwise) for Eylea, and despite the company launching a newer formulation of the medicine that is performing well, combined sales of the two versions are still dropping. The good news for Regeneron is that its most important asset continues to perform extremely well.

Image source: The Motley Fool.

Dupixent's rapidly growing sales
Regeneron developed Dupixent in collaboration with Sanofi (SNY +0.79%). The latter records global sales of the medicine and the two companies share U.S. profits equally, while Sanofi gets between 55% and 65% of the profits generated by the drug outside the U.S. Beyond eczema, Dupixent is approved for the treatment of COPD -- an indication it earned in the U.S. just about two years ago -- asthma, and several other conditions. The drug has been posting excellent sales growth and has been instrumental in helping Regeneron overcome its recent challenges.

In the second quarter, Regeneron's revenue grew by a healthy 17% year over year to $4.3 billion. Global sales of Dupixent came in at $6 billion, up 38% year over year. Regeneron's revenue generated from its collaboration with Sanofi grew 51% year over year to $2.2 billion thanks to Dupixent's performance. Regeneron's non-GAAP net income per share jumped 11% year over year to $14.29.

The company's performance was strong, despite lingering Eylea-related headwinds. U.S. sales of the original version of Eylea dropped by 45% year over year to $412 million. The newer, higher dose (HD) formulation performed much better. It posted U.S. revenue of $596 million, up 52% compared to the year-ago period. But combined U.S. revenue from both formulations dropped 12% year over year to about $1 billion. The fact that Regeneron posted a solid quarterly update despite its Eylea-related problems is encouraging.

REGN Regeneron Pharmaceuticals$790.74-$5.60 (-0.70%)

NASDAQ · As of 4:00 PM ET 10/16/26

Where will Regeneron be in five years?
Dupixent is already one of the top-selling drugs in the world, and it should remain so through the end of the decade. Sanofi now expects the medicine to hit 25 billion euros ($27.8 billion) in peak revenue by 2030. So, it should remain a meaningful growth driver. However, the medicine could start facing biosimilar competition in the early 2030s.

Can Regeneron survive that threat? In my view, it can, and here are three reasons why. First, Regeneron and Sanofi plan to defend their Dupixent empire, notably by developing and marketing a different formulation of the medicine that could improve dosing convenience and help it retain many patients beyond the original's patent expiration.

This is the playbook Regeneron followed with Eylea. And while combined sales of Eylea and Eylea HD are declining, that's partly because some patients are switching to the newer, more convenient formulation. Things would be a lot worse for Regeneron had it not earned approval for Eylea HD. Second, Regeneron and Sanofi are collaborating to develop medicines to replace Dupixent.

It's too early to tell whether they will be successful, but it is an encouraging sign for investors. Third, Regeneron has exciting pipeline candidates of its own that could help it navigate a patent cliff for Dupixent down the road. For instance, the company licensed olatorepatide, an investigational weight-loss medicine that mimics the actions of the GLP-1 and GIP hormones, from a China-based biotech.

Olatorepatide appears highly promising. In a Phase 3 study conducted in China, the treatment resulted in a mean weight loss of up to 19% over 48 weeks. Regeneron still needs to conduct clinical trials in the U.S., but olatorepatide could enable the company to capitalize on the rapidly growing weight loss market. Regeneron boasts several other promising candidates as well. Dupixent should remain the company's main growth driver for the foreseeable future, but beyond that, the biotech leader could perform well, provided it makes significant clinical and regulatory progress over the next few years. I'd wager that Regeneron can do so and deliver competitive returns over the medium term.
2026-10-16 18:06 8d ago
2026-10-16 04:44 8d ago
2,281 Shares in Regeneron Pharmaceuticals, Inc. $REGN Bought by First Citizens Bank & Trust Co.
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
First Citizens Bank & Trust Co. bought a new stake in shares of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Free Report) during the third quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The fund bought 2,281 shares of the biopharmaceutical company’s stock, valued at approximately $1,730,000.

Other hedge funds also recently bought and sold shares of the company. Signal Advisors Wealth LLC purchased a new stake in shares of Regeneron Pharmaceuticals during the third quarter worth about $201,000. B. Riley Wealth Advisors Inc. lifted its holdings in Regeneron Pharmaceuticals by 49.8% in the 3rd quarter. B. Riley Wealth Advisors Inc. now owns 620 shares of the biopharmaceutical company’s stock worth $470,000 after purchasing an additional 206 shares in the last quarter. Krilogy Financial LLC lifted its holdings in Regeneron Pharmaceuticals by 31.7% in the 3rd quarter. Krilogy Financial LLC now owns 2,474 shares of the biopharmaceutical company’s stock worth $1,887,000 after purchasing an additional 596 shares in the last quarter. RHS Financial LLC bought a new position in Regeneron Pharmaceuticals in the 3rd quarter worth approximately $202,000. Finally, Forvis Mazars Wealth Advisors LLC boosted its stake in Regeneron Pharmaceuticals by 9.2% in the 3rd quarter. Forvis Mazars Wealth Advisors LLC now owns 3,287 shares of the biopharmaceutical company’s stock worth $2,493,000 after purchasing an additional 278 shares during the period. Institutional investors own 83.31% of the company’s stock.

Insider Activity In other news, insider Andrew J. Murphy sold 4,147 shares of the stock in a transaction that occurred on Wednesday, October 14th. The stock was sold at an average price of $772.70, for a total value of $3,204,386.90. Following the sale, the insider directly owned 47,833 shares in the company, valued at approximately $36,960,559.10. This represents a 7.98% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which can be accessed through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, EVP Marion Mccourt sold 1,215 shares of Regeneron Pharmaceuticals stock in a transaction on Wednesday, September 2nd. The stock was sold at an average price of $850.00, for a total value of $1,032,750.00. Following the sale, the executive vice president owned 13,134 shares of the company’s stock, valued at approximately $11,163,900. This trade represents a 8.47% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last three months, insiders have sold 8,093 shares of company stock worth $6,506,845. 6.97% of the stock is currently owned by insiders.

Analyst Upgrades and Downgrades A number of equities research analysts have issued reports on the stock. Robert W. Baird increased their price objective on shares of Regeneron Pharmaceuticals from $742.00 to $761.00 and gave the company a “neutral” rating in a report on Friday, July 31st. Royal Bank Of Canada boosted their target price on shares of Regeneron Pharmaceuticals from $737.00 to $810.00 and gave the stock a “sector perform” rating in a report on Thursday, October 8th. Zacks Research upgraded shares of Regeneron Pharmaceuticals from a “hold” rating to a “strong-buy” rating in a research report on Monday, September 28th. JPMorgan Chase & Co. upped their target price on shares of Regeneron Pharmaceuticals from $900.00 to $950.00 and gave the stock an “overweight” rating in a research report on Tuesday, October 6th. Finally, Sanford C. Bernstein raised their target price on shares of Regeneron Pharmaceuticals from $753.00 to $756.00 and gave the company a “market perform” rating in a research note on Friday, August 14th. One research analyst has rated the stock with a Strong Buy rating, twenty-two have assigned a Buy rating and eight have issued a Hold rating to the company’s stock. Based on data from MarketBeat.com, Regeneron Pharmaceuticals has a consensus rating of “Moderate Buy” and an average price target of $845.21. Get Our Latest Report on REGN

Key Headlines Impacting Regeneron Pharmaceuticals Here are the key news stories impacting Regeneron Pharmaceuticals this week:

Positive Sentiment: UBS upgraded Regeneron to “Buy” and raised its price target to $978 from $660, arguing that the market is underestimating the long-term opportunity for Dupixent. The new target implies substantial upside and is the clearest near-term catalyst for investor optimism. Tickerreport UBS upgrade article Positive Sentiment: A valuation analysis says Regeneron still appears below fair value after fresh trial data and renewed attention on its immunology alliance. The report suggests the company’s earnings power may not be fully reflected in its current valuation. Regeneron stock fair value article Positive Sentiment: Regeneron could benefit from having paid off its balance owed to Sanofi, which had reduced the revenue reported from their partnership. The change may improve the financial contribution from the collaboration going forward. Trefis Regeneron catalysts article Positive Sentiment: Analysts expect double-digit bottom-line growth in the upcoming third-quarter report, keeping earnings momentum and the company’s ability to exceed estimates in focus. Barchart Regeneron earnings preview Neutral Sentiment: A review of biotechnology-sector results included Regeneron among the companies investors are evaluating, but provided limited new company-specific information. Yahoo Finance biotechnology earnings review Negative Sentiment: Director Andrew Murphy sold 4,147 shares worth approximately $3.2 million under a pre-arranged Rule 10b5-1 plan. Because the sale was scheduled in advance, it is a limited bearish signal, although it may weigh modestly on sentiment. Regeneron Pharmaceuticals Trading Up 2.3% REGN stock opened at $796.34 on Friday. The firm has a fifty day moving average price of $791.59 and a 200 day moving average price of $721.30. Regeneron Pharmaceuticals, Inc. has a fifty-two week low of $564.00 and a fifty-two week high of $859.34. The firm has a market cap of $81.99 billion, a PE ratio of 19.68, a price-to-earnings-growth ratio of 1.35 and a beta of 0.16. The company has a debt-to-equity ratio of 0.06, a quick ratio of 2.78 and a current ratio of 3.34.

Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) last released its quarterly earnings results on Thursday, July 30th. The biopharmaceutical company reported $14.29 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of $10.16 by $4.13. Regeneron Pharmaceuticals had a net margin of 27.86% and a return on equity of 13.47%. The company had revenue of $4.29 billion for the quarter, compared to the consensus estimate of $3.82 billion. During the same quarter in the prior year, the firm earned $12.81 earnings per share. Regeneron Pharmaceuticals’s revenue was up 16.7% on a year-over-year basis. Sell-side analysts anticipate that Regeneron Pharmaceuticals, Inc. will post 47.93 earnings per share for the current fiscal year.

Regeneron Pharmaceuticals Announces Dividend The business also recently disclosed a quarterly dividend, which was paid on Monday, August 31st. Stockholders of record on Tuesday, August 18th were paid a $0.94 dividend. This represents a $3.76 annualized dividend and a dividend yield of 0.5%. The ex-dividend date of this dividend was Tuesday, August 18th. Regeneron Pharmaceuticals’s dividend payout ratio (DPR) is presently 9.29%.

(Free Report)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses human genetics, antibody technology and other biological research platforms to develop treatments in areas including eye diseases, cancer, cardiovascular and metabolic disorders, inflammatory diseases, infectious diseases and rare conditions.

Regeneron’s marketed products include EYLEA and EYLEA HD for certain retinal diseases; Dupixent, developed and commercialized with Sanofi, for multiple allergic and inflammatory conditions; Libtayo for certain cancers; Praluent for high cholesterol; Kevzara for rheumatoid arthritis and other inflammatory diseases; Evkeeza for homozygous familial hypercholesterolemia; and Veopoz for a rare immune-mediated disorder.

See Also Five stocks we like better than Regeneron Pharmaceuticals ASML Can’t Keep Up With AI Demand—Why That’s a Good Thing Enovix’s 100,000-Battery Drone Order Sets Up a Test of Its Production Plans AMD’s Support Could Help Fermi Stock Overcome Its Biggest Hurdle Beyond the GPU: Credo Paves the Next AI Data Superhighway Want to see what other hedge funds are holding REGN? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Free Report).

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2026-10-16 13:08 8d ago
2026-10-16 07:00 8d ago
Libtayo® (cemiplimab) Recommended for EU Approval by the CHMP for Updated Dosing Regimen Across All Approved Cancer Types
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Positive opinion supports reducing Libtayo dosing frequency from every three weeks to every six weeks after first 12 weeks of treatment
2026-10-13 16:11 11d ago
2026-10-13 07:25 11d ago
Regeneron Pharmaceuticals, Inc. $REGN Shares Bought by NorthCrest Asset Manangement LLC
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
NorthCrest Asset Manangement LLC boosted its stake in Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) by 7.5% during the undefined quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The institutional investor owned 10,712 shares of the biopharmaceutical company's stock after acquiring an additional 749 shares during the
2026-10-13 16:11 11d ago
2026-10-13 09:56 11d ago
These 2 Medical Stocks Could Beat Earnings: Why They Should Be on Your Radar
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Two factors often determine stock prices in the long run: earnings and interest rates. Investors can't control the latter, but they can focus on a company's earnings results every quarter.

The earnings figure itself is key, of course, but a beat or miss on the bottom line can sometimes be just as, if not more, important. Therefore, investors should consider paying close attention to these earnings surprises, as a big beat can help a stock climb and vice versa.

Hunting for 'earnings whispers' or companies poised to beat their quarterly earnings estimates is a somewhat common practice. But that doesn't make it easy. One way that has been proven to work is by using the Zacks Earnings ESP tool.

The Zacks Earnings ESP, ExplainedThe Zacks Expected Surprise Prediction, or ESP, works by locking in on the most up-to-date analyst earnings revisions because they can be more accurate than estimates from weeks or even months before the actual release date. The thinking is pretty straightforward: analysts who provide earnings estimates closer to the report are likely to have more information.

With this in mind, the Expected Surprise Prediction compares the Most Accurate Estimate (being the most recent) against the overall Zacks Consensus Estimate. The percentage difference provides the ESP figure. The system also utilizes our core Zacks Rank to provide a stronger system for identifying stocks that might beat their next quarterly earnings estimate and possibly see the stock price climb.

In fact, when we combined a Zacks Rank #3 (Hold) or better and a positive Earnings ESP, stocks produced a positive surprise 70% of the time. Perhaps most importantly, using these parameters has helped produce 28.3% annual returns on average, according to our 10 year backtest.

Stocks with a ranking of #3 (Hold), or 60% of all stocks covered by the Zacks Rank, are expected to perform in-line with the broader market. Stocks with rankings of #2 (Buy) and #1 (Strong Buy), or the top 15% and top 5% of stocks, respectively, should outperform the market; Strong Buy stocks should outperform more than any other rank.

Should You Consider ANI Pharmaceuticals?Now that we understand what the ESP is and how beneficial it can be, let's dive into a stock that currently fits the bill. ANI Pharmaceuticals (ANIP - Free Report) earns a #3 (Hold) right now and its Most Accurate Estimate sits at $2.31 a share, just 24 days from its upcoming earnings release on November 6, 2026.

ANI Pharmaceuticals' Earnings ESP sits at +6.45%, which, as explained above, is calculated by taking the percentage difference between the $2.31 Most Accurate Estimate and the Zacks Consensus Estimate of $2.17. ANIP is also part of a large group of stocks that boast a positive ESP. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

ANIP is one of just a large database of Medical stocks with positive ESPs. Another solid-looking stock is Regeneron (REGN - Free Report) .

Regeneron, which is readying to report earnings on October 30, 2026, sits at a Zacks Rank #3 (Hold) right now. Its Most Accurate Estimate is currently $15.96 a share, and REGN is 17 days out from its next earnings report.

The Zacks Consensus Estimate for Regeneron is $15.93, and when you take the percentage difference between that number and its Most Accurate Estimate, you get the Earnings ESP figure of +0.23%.

ANIP and REGN's positive ESP metrics may signal that a positive earnings surprise for both stocks is on the horizon.

Find Stocks to Buy or Sell Before They're ReportedUse the Zacks Earnings ESP Filter to turn up stocks with the highest probability of positively, or negatively, surprising to buy or sell before they're reported for profitable earnings season trading. Check it out here >>
2026-10-13 06:17 11d ago
2026-10-12 12:06 12d ago
Pasatru™ (garetosmab-grts) Demonstrates Zero New Heterotopic Ossification (HO) Lesions in Adult Fibrodysplasia Ossificans Progressiva (FOP) Patients During OPTIMA Trial Extension
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Pasatru is the first and only FDA-approved treatment demonstrating reductions in both new HO lesions and clinician-assessed flare-ups, per results of a 56-week placebo-controlled trial in adults with FOP

Late-breaking data presented at ASBMR show sustained efficacy of Pasatru and a consistent safety profile from weeks 56 to 84, supporting long-term disease control

TARRYTOWN, N.Y., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive 84-week results from the Phase 3 OPTIMA trial evaluating Pasatru™ (garetosmab-grts) in adults with fibrodysplasia ossificans progressiva (FOP). These longer-term findings for Pasatru demonstrated sustained efficacy in halting new, rogue bone growth and in significantly reducing disease flare-ups, and were presented during a late-breaking oral session at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting. Pasatru was recently approved by the U.S. Food and Drug Administration (FDA) based on a 56-week, placebo-controlled trial to reduce the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with FOP. Pasatru is a VelocImmune®-derived, fully human monoclonal antibody that binds to and inhibits signaling by the Activin A protein, which Regeneron scientists discovered to be a critical protein involved in the development of HO lesions in people with FOP.

“FOP is a devastating, relentless condition in which every flare-up can bring anxiety around potential new, abnormal bone growth and resulting loss of mobility,” said Professor Richard Keen, Director of the Metabolic Bone Disease Centre, Royal National Orthopaedic Hospital, London, and global primary investigator of the OPTIMA trial. “What patients urgently need is long-term control over new HO lesions and flare-ups to help bring peace of mind. The 84-week data from the Phase 3 OPTIMA trial demonstrate sustained disease-modifying control alongside a generally well-tolerated safety profile, which is important for the adult FOP community.”

OPTIMA, a global, multi-center, randomized, double-blind, placebo-controlled trial, enrolled 63 people with FOP aged 18 years and older. Trial participants were randomized to receive intravenously administered Pasatru 10 mg/kg, Pasatru 3 mg/kg, or placebo once every four weeks for 56 weeks. Following this, 58 participants completed the double-blind extension phase to at least 84 weeks.

At 56 weeks, OPTIMA met its primary endpoint, demonstrating a 90% or greater reduction in new HO lesions, with a dramatic reduction in clinician-assessed flare-ups in adults with FOP. Detailed results on these 56-week data were recently published in The Lancet. The endpoints were then re-assessed at 84 weeks. From week 56, there were no new HO lesions observed at week 84 for Pasatru compared to 9 new lesions for placebo as assessed by computed tomography (CT) scan. Additionally, one new HO lesion previously detected at week 56 for Pasatru 3 mg/kg was no longer detectable at week 84. The number of new clinician-assessed flare-ups was also reduced compared to placebo, notably with 1 observed for Pasatru 10 mg/kg, 14 for Pasatru 3 mg/kg, and 17 for placebo.

Through week 84, both doses of Pasatru had a generally well-tolerated safety profile, consistent with that observed at 56 weeks. At 56 weeks, the most common adverse reactions occurring in ≥10% of adults with FOP treated with Pasatru were abscess, acne, increased hair growth, madarosis (hair loss of eyebrows or lashes), oral ulcers, epistaxis (nosebleeds), folliculitis, paronychia (nail infection), and rash. At 84 weeks, the most common treatment-emergent adverse events were acne in participants treated with Pasatru 10 mg/kg and epistaxis (all non-severe) in participants treated with Pasatru 3 mg/kg. Treatment-emergent bleeding events were lower in participants treated with Pasatru 10 mg/kg than those treated with Pasatru 3 mg/kg or placebo. There was a dose-dependent increase in skin and soft tissue infections (33% on placebo, 53% on Pasatru 3 mg/kg, and 78% on Pasatru 10 mg/kg) that were all resolved with further management, with no patients discontinuing treatment as a result of infection. No deaths were reported in the trial.

A Phase 3 trial of Pasatru in adolescents and children with FOP, OPTIMA 2, is planned to begin later this year. For more information, visit the Regeneron clinical trials website, contact [email protected], or call +1 844-734-6643.

About FOP
FOP is an ultra-rare genetic disorder in which muscle, ligaments, and connective tissue are progressively infiltrated by rogue bone formation, a process known as HO. HO of the jaw, spine, hip, and rib cage can make basic actions such as speaking, eating, walking, or breathing difficult, leading to skeletal deformity, weight loss, and escalating loss of mobility. Worldwide, approximately 900 people are known to have been diagnosed with FOP, and most patients become wheelchair users by age 30, with the median age of survival being approximately 56.

About the OPTIMA Clinical Trial 
OPTIMA is a Phase 3, multi-center, multinational trial to assess the efficacy of Pasatru on the reduction of heterotopic bone formation and flares, as well as its safety, tolerability, and pharmacokinetics, in patients with active FOP. 

The trial enrolled 63 participants aged 18 years and older who have any FOP-causing variant of type I Activin A receptor (ACVR1), exhibited FOP disease activity or progression of HO lesions, and had a cumulative analogue joint involvement scale (CAJIS) score at screening of ≤19. CAJIS is a scoring tool used by clinicians to assess the degree of joint involvement, with higher scores representing a greater degree of disease severity (scale: 0 to 30). Eligible participants were randomized to receive intravenously administered Pasatru 10 mg/kg, Pasatru 3 mg/kg, or placebo once every four weeks for 56 weeks. Following this, participants could then elect to continue their originally assigned treatment in a double-blind extension phase for at least 84 weeks or discontinue treatment and enter an observation-only arm.

During the treatment period, efficacy was evaluated through whole body CT scans for HO lesions, physician and patient assessment of flare-ups, utilization of CAJIS to rate joint functionality, and observances of change in disease severity. The safety assessment includes reports of adverse events, measurement of vital signs, physical examination, and coagulation testing. 

About Pasatru
Regeneron has been engaged in FOP research for decades and helped to provide fundamental insights into the biology and natural history of the disease. Regeneron scientists discovered that Activin A plays a key role in FOP by driving HO, the main pathology of FOP. Pasatru is a VelocImmune-derived, fully human monoclonal antibody that binds to and inhibits signaling by the Activin A protein, which is involved in the development of heterotopic bone in people with FOP.

Pasatru is FDA-approved in the U.S. to reduce formation of new HO lesions and clinician-assessed flare-ups in adults with FOP. In the European Union, a regulatory submission for Pasatru is currently under review by the European Medicines Agency. Additional regulatory submissions are planned in countries around the world, including Japan. Pasatru previously received Fast Track designation and Orphan Drug Designation from the FDA, as well as Orphan Designation by the European Medicines Agency in the European Union and the Ministry of Health, Labour and Welfare in Japan.

Regeneron is committed to supporting people living with rare diseases. Regeneron’s myRARE™ program offers resources to help patients and healthcare providers, including product information, insurance benefit verification, and information about potential financial support. To learn about myRARE, visit myRARE.com or call 1-833-4my-RARE (1-833-469-7273).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PASATRU?

PASATRU can cause serious side effects, including:

Harm to your unborn baby, including serious birth defects if taken during pregnancy. Females who are pregnant must not take PASATRU. Females who can become pregnant: Your healthcare provider will ask you to take a pregnancy test to verify that you are not pregnant before starting treatment with PASATRU.Use effective birth control (contraception) during treatment with PASATRU and for 6 months after the last dose of PASATRU. Talk to your healthcare provider about birth control methods that may be right for you.If you become pregnant or think you may be pregnant during treatment with PASATRU, stop taking PASATRU immediately and call your healthcare provider right away. Infections of the skin and tissue under the skin requiring treatment or hospitalization, such as infected lumps (abscesses) and bacterial skin infections (cellulitis), may happen while you are taking PASATRU. Call your healthcare provider right away if you have signs or symptoms of skin infection, such as:  •  redness•  pain or tenderness •  skin feels warm to the touch•  fever •  swelling•  feeling generally unwell    Nosebleeds (epistaxis), including serious nosebleeds that require medical care, can happen while taking PASATRU. Tell your healthcare provider right away if you have a nosebleed that: is severe or heavydoes not stop with basic first-aid measures, such as pinching your nose with continuous firm pressurelasts more than 20 minutes Do not receive PASATRU if you are pregnant.

Before you receive PASATRU, tell your healthcare provider about all your medical conditions, including if you:

are breastfeeding. It is not known whether PASATRU passes into your breastmilk. Breastfeeding is not recommended during treatment with PASATRU and for 6 months after the last dose of PASATRU. Talk to your healthcare provider about the best way to feed your baby during this time.are concerned about male fertility. PASATRU may affect your ability to father a child. Talk to your healthcare provider if this is concern for you. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of PASATRU include:

 •  infected lumps (abscess)•  hair loss of eyebrows or lashes (madarosis) •  acne•  mouth sores (oral ulcers) •  increased hair growth•  nosebleeds (epistaxis)    These are not all of the possible side effects of PASATRU. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is PASATRU?

PASATRU™ (garetosmab-grts) is a prescription medicine used to reduce the formation of new abnormal bone growth outside of the skeleton (heterotopic ossification) and flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).

It is not known if PASATRU is safe and effective in children.

Please click here for full Prescribing Information, including Medication Guide.

About Regeneron’s VelocImmune Technology 
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce fully optimized human antibodies. When Regeneron’s Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor, Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz® (pozelimab-bbfg), and Pasatru™ (garetosmab-grts). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. 

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media 

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Pasatru™ (garetosmab-grts) for the treatment of adults with fibrodysplasia ossificans progressiva (“FOP”); uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products (such as Pasatru) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including Pasatru for the treatment of adolescents and children with FOP; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Pasatru) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).
2026-10-12 17:59 12d ago
2026-10-12 13:10 12d ago
Will Regeneron (REGN) Beat Estimates Again in Its Next Earnings Report?
REGN Regeneron Pharmaceuticals
FMP Stock News
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Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Regeneron (REGN - Free Report) , which belongs to the Zacks Medical - Biomedical and Genetics industry.

This biopharmaceutical company has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 27.03%.

For the last reported quarter, Regeneron came out with earnings of $14.29 per share versus the Zacks Consensus Estimate of $10 per share, representing a surprise of 42.90%. For the previous quarter, the company was expected to post earnings of $8.52 per share and it actually produced earnings of $9.47 per share, delivering a surprise of 11.15%.

Price and EPS Surprise

For Regeneron, estimates have been trending higher, thanks in part to this earnings surprise history. And when you look at the stock's positive Zacks Earnings ESP (Expected Surprise Prediction), it's a great indicator of a future earnings beat, especially when combined with its solid Zacks Rank.

Our research shows that stocks with the combination of a positive Earnings ESP and a Zacks Rank #3 (Hold) or better produce a positive surprise nearly 70% of the time. In other words, if you have 10 stocks with this combination, the number of stocks that beat the consensus estimate could be as high as seven.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a version of the Zacks Consensus whose definition is related to change. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Regeneron currently has an Earnings ESP of +1.21%, which suggests that analysts have recently become bullish on the company's earnings prospects. This positive Earnings ESP when combined with the stock's Zacks Rank #3 (Hold) indicates that another beat is possibly around the corner. We expect the company's next earnings report to be released on October 30, 2026.

With the Earnings ESP metric, it's important to note that a negative value reduces its predictive power; however, a negative Earnings ESP does not indicate an earnings miss.

Many companies end up beating the consensus EPS estimate, though this is not the only reason why their shares gain. Additionally, some stocks may remain stable even if they end up missing the consensus estimate.

Because of this, it's really important to check a company's Earnings ESP ahead of its quarterly release to increase the odds of success. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
2026-10-12 17:59 12d ago
2026-10-12 13:34 12d ago
Regeneron Says Newly Approved Drug Shows Sustained Efficacy In Halting Rogue Bone Growth
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) on Monday shared encouraging 84-week findings from the Phase 3 OPTIMA trial for its drug Pasatru (garetosmab-grts).

• Regeneron Pharmaceuticals shares are advancing steadily. Why is REGN stock trading higher?

The results, presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, demonstrate the drug’s sustained effectiveness in treating adults with fibrodysplasia ossificans progressiva (FOP).

FOP (aka stone man disease) is an ultra-rare genetic connective tissue disorder that causes muscles, tendons, ligaments, and other soft tissues to permanently transform into bone (heterotopic ossification).

This creates a “second skeleton” that progressively locks the body’s joints and restricts movement.

Sustained Efficacy In Halting Rogue Bone GrowthThe longer-term data reveal that Pasatru continues to effectively halt new, abnormal bone growth and significantly reduce disease flare-ups in FOP patients.

Read Next

This fully human monoclonal antibody, derived from the company’s VelocImmune technology, targets and inhibits the Activin A protein.

Regeneron scientists identified this protein as a crucial factor in the development of heterotopic ossification (HO) lesions associated with FOP.

The OPTIMA trial involved 63 adults with FOP.

Consistent Results Over 84 WeeksThe trial met its primary endpoint at 56 weeks, showing a dramatic reduction in new HO lesions and flare-ups, leading to recent FDA approval for Pasatru. The positive trend continued at the 84-week mark.

From week 56 to 84, no new HO lesions were observed in the Pasatru group, compared to nine in the placebo group.

Notably, the Pasatru 10 mg/kg dose saw only one new clinician-assessed flare-up, compared to 17 in the placebo group.

Safety and Future PlansThe safety profile of Pasatru remained generally well-tolerated through week 84, consistent with the 56-week data.

While there was a dose-dependent increase in skin and soft tissue infections, all cases were resolved with management, and no patients discontinued treatment due to infection.

Regeneron plans to initiate a Phase 3 trial, OPTIMA 2, for adolescents and children with FOP later this year.

REGN Price Action: Regeneron Pharmaceuticals shares were up 2.66% at $766.38 at the time of publication on Monday, according to Benzinga Pro data.

Photo: Photoroyalty via Shutterstock

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© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
2026-10-09 16:24 15d ago
2026-10-09 10:41 15d ago
Why Regeneron (REGN) is a Top Value Stock for the Long-Term
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Taking full advantage of the stock market and investing with confidence are common goals for new and old investors, and Zacks Premium offers many different ways to do both.

Featuring daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, the research service can help you become a smarter, more self-assured investor.

Zacks Premium includes access to the Zacks Style Scores as well.

What are the Zacks Style Scores? The Zacks Style Scores is a unique set of guidelines that rates stocks based on three popular investing types, and were developed as complementary indicators for the Zacks Rank. This combination helps investors choose securities with the highest chances of beating the market over the next 30 days.

Each stock is given an alphabetic rating of A, B, C, D or F based on their value, growth, and momentum qualities. With this system, an A is better than a B, a B is better than a C, and so on, meaning the better the score, the better chance the stock will outperform.

The Style Scores are broken down into four categories:

Value ScoreValue investors love finding good stocks at good prices, especially before the broader market catches on to a stock's true value. Utilizing ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and many other multiples, the Value Style Score identifies the most attractive and most discounted stocks.

Growth ScoreGrowth investors are more concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, the Growth Style Score analyzes characteristics like projected and historic earnings, sales, and cash flow to find stocks that will see sustainable growth over time.

Momentum ScoreMomentum trading is all about taking advantage of upward or downward trends in a stock's price or earnings outlook, and these investors live by the saying "the trend is your friend." The Momentum Style Score can pinpoint good times to build a position in a stock, using factors like one-week price change and the monthly percentage change in earnings estimates.

VGM ScoreIf you like to use all three kinds of investing, then the VGM Score is for you. It's a combination of all Style Scores, and is an important indicator to use with the Zacks Rank. The VGM Score rates each stock on their shared weighted styles, narrowing down the companies with the most attractive value, best growth forecast, and most promising momentum.

How Style Scores Work with the Zacks Rank A proprietary stock-rating model, the Zacks Rank utilizes the power of earnings estimate revisions, or changes to a company's earnings outlook, to help investors create a successful portfolio.

It's highly successful, with #1 (Strong Buy) stocks producing an unmatched +23.86% average annual return since 1988. That's more than double the S&P 500. But because of the large number of stocks we rate, there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.

With more than 800 top-rated stocks to choose from, it can certainly feel overwhelming to pick the ones that are right for you and your investing journey.

That's where the Style Scores come in.

To maximize your returns, you want to buy stocks with the highest probability of success. This means picking stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you find yourself looking at stocks with a #3 (Hold) rank, make sure they have Scores of A or B as well to ensure as much upside potential as possible.

As mentioned above, the Scores are designed to work with the Zacks Rank, so any change to a company's earnings outlook should be a deciding factor when picking which stocks to buy.

A stock with a #4 (Sell) or #5 (Strong Sell) rating, for instance, even one with Scores of A and B, will still have a declining earnings forecast, and a greater chance its share price will fall too.

Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.

Stock to Watch: Regeneron (REGN - Free Report) Tarrytown, NY-based Regeneron is a biotechnology company focused on the discovery, development and commercialization of treatments targeting severe medical conditions. The company’s portfolio includes Eylea (for several eye diseases), Eylea HD (higher dose of Eylea), partnered drug Dupixent (atopic dermatitis, chronic spontaneous urticaria, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, bullous pemphigoid and allergic fungal rhinosinusitis), Libtayo (lung cancer, advanced basal cell carcinoma, metastatic or locally advanced cutaneous squamous cell carcinoma, cervical cancer, adjuvant cutaneous squamous cell carcinoma), Praluent (heterozygous familial hypercholesterolemia and homozygous familial hypercholesterolemia), Kevzara (moderately-to-severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis), Evkeeza (homozygous familial hypercholesterolemia), Ordspono (follicular lymphoma and diffuse large B-cell lymphoma), Lynozyfic (relapsed/refractory multiple myeloma), Inmazeb (Ebola), Veopoz (CHAPLE disease), Arcalyst, Zaltrap, Otarmeni (hearing loss associated with variants in the OTOF gene) and Pasatru.

REGN is a #3 (Hold) on the Zacks Rank, with a VGM Score of B.

It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 13.47; value investors should take notice.

Two analysts revised their earnings estimate higher in the last 60 days for fiscal 2026, while the Zacks Consensus Estimate has increased $1.79 to $54.90 per share. REGN also boasts an average earnings surprise of +21.9%.

With a solid Zacks Rank and top-tier Value and VGM Style Scores, REGN should be on investors' short list.
2026-10-06 17:05 18d ago
2026-10-06 09:02 18d ago
Regeneron (NASDAQ: REGN) signs $1.0 billion Sanofi pact for new antibodies
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
What happened Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) said on October 1, 2026, it entered the Sixth Amendment with Sanofi. Under the amendment, Sanofi will make a $1.0 billion upfront payment.

The companies also agreed to co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies that target IL-13, IL-4, IL-4R and IL-4xIL-13. Global profits on sales of the New Licensed Products will be shared equally. Regeneron will be the lead development and lead regulatory party before applications for marketing approval.

Regeneron will remain the lead regulatory party for applications for marketing approval and further commercialization in the United States. Sanofi will be the lead regulatory party for applications for marketing approval and further commercialization outside the United States. Regeneron can also opt in, asset by asset, to Sanofi's Phase 2/3 asset lunsekimig and another early development product after certain trials. If it exercises that option, it will reimburse Sanofi for certain development costs.

In the same filing, Regeneron said it and Sanofi entered a settlement agreement. Under it, Regeneron agreed to dismiss its lawsuit over information access and audit rights.

Key numbers Metric Latest Change Source Upfront payment $1.0 billion SEC 8-K Potential milestone payments up to an additional $7.0 billion SEC 8-K New long-acting antibodies 4 antibodies SEC 8-K Expected acquired IPR&D charge $22 million SEC 8-K Expected net income per diluted share impact -$0.18 SEC 8-K Read more: Regeneron Pharmaceuticals (REGN) stock analysis and investment case

Why it matters OptimistFi's case is that Regeneron turns a concentrated set of approved biologics into durable free cash flow that funds research and development, buybacks and pipeline investment. This agreement is mixed for that case.

The $1.0 billion upfront payment is about 45 times the approximately $22 million pre-tax acquired in-process research and development charge Regeneron expects in third quarter 2026. That gives Regeneron immediate cash and shared economics if the antibodies succeed. But the filing says up to an additional $7.0 billion depends on development, regulatory and commercial milestones.

It also says development costs above a budget cap fall to Regeneron, subject to later recoupment. The separate settlement also means Regeneron agreed to dismiss a lawsuit tied to Dupixent information access and audit rights.

Browse: stock research on every company OptimistFi covers

What's next Regeneron said the full Sixth Amendment will be filed as an exhibit to the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2026. That filing will also include Regeneron's final third-quarter 2026 results, which are still subject to closing procedures.

A filing that confirms the $1.0 billion payment and the expected charge would support the cash-flow case. Slippage on either would weaken it.

More from OptimistFi REGN stock: the Regeneron Pharmaceuticals thesis, its status and the next test to watch United States Brent Oil Fund, LP (NYSE Arca: BNO) Tracks a Supply Gap Alpha Teknova, Inc. (NASDAQ: TKNO) Adds Regulatory Support for PluriFreeze Meta Platforms, Inc. (NASDAQ: META) Has a Conditional $18 Billion Bill Stock research on every company OptimistFi covers Latest stock research and investment-case updates OptimistFi: evidence-first equity research Sources SEC 8-K — Current report on Form 8-K covering the Sixth Amendment, settlement and third-quarter charge estimate. Read the full OptimistFi thesis on Regeneron Pharmaceuticals, Inc.: https://optimistfi.com/stocks/REGN

See what would break the Regeneron Pharmaceuticals, Inc. thesis and track it live on the OptimistFi Thesis-Break Engine.

Browse every company OptimistFi covers at optimistfi.com/stocks, or read the latest evidence-first research.

The full Regeneron Pharmaceuticals, Inc. investment case, its status and the next test to watch live on the Regeneron Pharmaceuticals, Inc. thesis page.

Originally published on OptimistFi, evidence-first equity research. More at optimistfi.com.
2026-10-06 14:37 18d ago
2026-10-06 07:06 18d ago
Regeneron Pharmaceuticals, Inc. $REGN Shares Bought by Central Pacific Bank Trust Division
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Central Pacific Bank Trust Division raised its holdings in Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Free Report) by 90.3% during the 3rd quarter, according to its most recent disclosure with the Securities and Exchange Commission (SEC). The institutional investor owned 2,687 shares of the biopharmaceutical company’s stock after purchasing an additional 1,275 shares during the period. Central Pacific Bank Trust Division’s holdings in Regeneron Pharmaceuticals were worth $2,037,000 at the end of the most recent reporting period.

Several other large investors have also modified their holdings of the business. Baker Tilly Wealth Management LLC raised its stake in Regeneron Pharmaceuticals by 3.6% in the 3rd quarter. Baker Tilly Wealth Management LLC now owns 1,461 shares of the biopharmaceutical company’s stock valued at $1,108,000 after purchasing an additional 51 shares during the last quarter. Eastern Bank boosted its stake in shares of Regeneron Pharmaceuticals by 31.6% during the 3rd quarter. Eastern Bank now owns 75 shares of the biopharmaceutical company’s stock worth $57,000 after purchasing an additional 18 shares during the last quarter. CX Institutional grew its holdings in shares of Regeneron Pharmaceuticals by 30.1% during the third quarter. CX Institutional now owns 501 shares of the biopharmaceutical company’s stock worth $380,000 after buying an additional 116 shares in the last quarter. Versant Capital Management Inc grew its holdings in shares of Regeneron Pharmaceuticals by 55.2% during the third quarter. Versant Capital Management Inc now owns 534 shares of the biopharmaceutical company’s stock worth $405,000 after buying an additional 190 shares in the last quarter. Finally, Envestnet Asset Management Inc. raised its position in shares of Regeneron Pharmaceuticals by 0.6% in the second quarter. Envestnet Asset Management Inc. now owns 109,838 shares of the biopharmaceutical company’s stock valued at $68,488,000 after buying an additional 686 shares during the last quarter. 83.31% of the stock is currently owned by institutional investors and hedge funds.

Regeneron Pharmaceuticals Stock Down 1.2% Shares of REGN opened at $726.47 on Tuesday. Regeneron Pharmaceuticals, Inc. has a fifty-two week low of $541.00 and a fifty-two week high of $859.34. The company’s fifty day moving average is $789.48 and its two-hundred day moving average is $720.45. The firm has a market cap of $74.80 billion, a PE ratio of 17.96, a price-to-earnings-growth ratio of 1.41 and a beta of 0.16. The company has a quick ratio of 2.78, a current ratio of 3.34 and a debt-to-equity ratio of 0.06.

Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) last released its quarterly earnings data on Thursday, July 30th. The biopharmaceutical company reported $14.29 EPS for the quarter, topping analysts’ consensus estimates of $10.16 by $4.13. The business had revenue of $4.29 billion during the quarter, compared to the consensus estimate of $3.82 billion. Regeneron Pharmaceuticals had a return on equity of 13.47% and a net margin of 27.86%.The business’s revenue for the quarter was up 16.7% on a year-over-year basis. During the same period in the prior year, the firm posted $12.81 EPS. Analysts forecast that Regeneron Pharmaceuticals, Inc. will post 45.34 earnings per share for the current year. Regeneron Pharmaceuticals Dividend Announcement The firm also recently announced a quarterly dividend, which was paid on Monday, August 31st. Investors of record on Tuesday, August 18th were given a dividend of $0.94 per share. This represents a $3.76 dividend on an annualized basis and a yield of 0.5%. The ex-dividend date of this dividend was Tuesday, August 18th. Regeneron Pharmaceuticals’s dividend payout ratio is 9.29%.

Insider Activity at Regeneron Pharmaceuticals In related news, EVP Marion Mccourt sold 1,215 shares of the firm’s stock in a transaction that occurred on Wednesday, September 2nd. The shares were sold at an average price of $850.00, for a total value of $1,032,750.00. Following the transaction, the executive vice president owned 13,134 shares in the company, valued at approximately $11,163,900. This trade represents a 8.47% decrease in their ownership of the stock. The transaction was disclosed in a filing with the SEC, which is accessible through the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Kathryn Guarini sold 400 shares of Regeneron Pharmaceuticals stock in a transaction that occurred on Wednesday, September 2nd. The shares were sold at an average price of $850.00, for a total transaction of $340,000.00. Following the transaction, the director directly owned 603 shares in the company, valued at approximately $512,550. This trade represents a 39.88% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last quarter, insiders have sold 3,946 shares of company stock worth $3,302,458. Company insiders own 6.97% of the company’s stock.

Analyst Ratings Changes Several analysts have commented on REGN shares. Cantor Fitzgerald lifted their target price on shares of Regeneron Pharmaceuticals from $750.00 to $795.00 and gave the stock an “overweight” rating in a research note on Friday, July 31st. Royal Bank Of Canada reissued a “sector perform” rating and set a $737.00 price target on shares of Regeneron Pharmaceuticals in a research note on Tuesday, September 29th. Guggenheim raised their price objective on Regeneron Pharmaceuticals from $1,000.00 to $1,030.00 and gave the stock a “buy” rating in a report on Monday, August 3rd. Piper Sandler lowered their price objective on Regeneron Pharmaceuticals from $855.00 to $854.00 and set an “overweight” rating for the company in a research report on Thursday, July 9th. Finally, Leerink Partners upped their target price on Regeneron Pharmaceuticals from $641.00 to $824.00 and gave the company a “market perform” rating in a research note on Monday, August 17th. One investment analyst has rated the stock with a Strong Buy rating, sixteen have assigned a Buy rating and nine have issued a Hold rating to the stock. According to data from MarketBeat, the stock presently has a consensus rating of “Moderate Buy” and an average target price of $809.50.

Check Out Our Latest Stock Analysis on REGN

(Free Report)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses human genetics, antibody technology and other biological research platforms to develop treatments in areas including eye diseases, cancer, cardiovascular and metabolic disorders, inflammatory diseases, infectious diseases and rare conditions.

Regeneron’s marketed products include EYLEA and EYLEA HD for certain retinal diseases; Dupixent, developed and commercialized with Sanofi, for multiple allergic and inflammatory conditions; Libtayo for certain cancers; Praluent for high cholesterol; Kevzara for rheumatoid arthritis and other inflammatory diseases; Evkeeza for homozygous familial hypercholesterolemia; and Veopoz for a rare immune-mediated disorder.

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2026-10-06 12:11 18d ago
2026-10-06 07:00 18d ago
Regeneron Showcases Advances in Care Across Several Cancers and Cancer-associated Complications at ESMO 2026
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Late-breaking Phase 3 C-POST data provide longer-term survival outcomes for adjuvant Libtayo® (cemiplimab) in high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation

Final Phase 2 analysis explores potential of Libtayo before surgery (neoadjuvant treatment) for patients with resectable CSCC

New data explore inhibition of Factor XI for cancer-associated thrombosis, a leading cause of cancer death, where bleeding risk limits use of anticoagulants

TARRYTOWN, N.Y., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of new clinical research at the European Society for Medical Oncology (ESMO) Congress 2026, taking place from October 23-27 in Madrid, Spain. Highlights from the company’s 10 abstracts will cover new data and analyses from trials in cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC), ovarian cancer, melanoma and cancer-associated thrombosis.

“At ESMO, we look forward to sharing data across a range of conditions reflecting the breadth of our research,” said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. “For the first time, we’re showcasing how our work extends beyond the treatment of cancer itself, and addresses some of the complex challenges patients face as a result of their disease. Together, these data reflect our broader commitment to advancing comprehensive cancer care for patients.”

Highlights include:

Adjuvant treatment with Libtayo in adults with CSCC with high risk of recurrence after surgery and radiation: Late-breaking overall survival (OS) data at approximately 3.5 years follow-up from the C-POST Phase 3 trial will provide further evidence supporting Libtayo as the standard of care in this indication. Neoadjuvant treatment with Libtayo in stage II-IV CSCC: Data include the final analysis of Phase 2 results, which represent the most mature data set in patients treated with Libtayo prior to surgery.Factor XI antibodies (cenvacibart and amrecibart) as a potential approach to reducing thrombosis in patients with cancer: Data include a Phase 2 sub-analysis and modeling in catheter-related VTE, plus an update on the Phase 3 ROXI-CAT-II trial. The full list of Regeneron presentations at ESMO are as follows:  

Abstract TitleAbstractPresenterSession Date/Time (CET)Skin CancerC-POST Phase 3 trial of adjuvant cemiplimab vs. placebo for high-risk CSCC: OS update at approximately 3.5 years' median follow-upLBA: 59
Danny RischinSunday
October 25,
10:15-11:45A Phase 2 study of neoadjuvant cemiplimab for Stage II--IV CSCC: final analysisPoster presentation: 2490PNeil D. GrossSaturday
October 24,
12:00-12:45Long-term Overall Survival (OS) with Fianlimab (FIAN) plus Cemiplimab (Cemi) in Advanced Melanoma (aMel): Survival Follow-up of a Phase 1 StudyPoster presentation: 2091POmid HamidSaturday
October 24,
12:00-12:45Lung CancerImpact of objective response on PROs in patients receiving cemiplimab + chemotherapy vs. placebo + chemotherapy for aNSCLC: EMPOWER-Lung 3 Part 2Poster presentation: 2714PKonstantin PenkovMonday
October 26,
12:00-12:45CEMI-LUNG, a European-based observational study to assess cemiplimab real world effectiveness and safety in patients with advanced non-small cell lung cancerPoster presentation: 2580PJesus Corral JaimeMonday
October 26,
12:00-12:45Ovarian CancerCirculating tumor DNA (ctDNA), cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) associate with survival outcomes in patients with platinum-resistant ovarian cancer treated with ubamatamabPoster presentation: 1957PJung-Yun LeeSaturday
October 24,
12:00-12:45A Phase 1/2 study of REGN5668 (ubamatamab) (mucin 16 [MUC16] × cluster of differentiation [CD]28 costimulatory bispecific antibody), in combination with other targeted therapies, in patients with recurrent ovarian cancer or endometrial cancer: Trial in progress updateePoster presentation: 1445eTiPRoisin E. O'CearbhaillN/AThrombosis (cenvacibart [REGN7508] and amrecibart [REGN9933])Phase 3 trial-in-progress evaluating cenvacibart for the treatment and secondary prevention of venous thromboembolism (VTE) in participants with solid and hematologic cancers (ROXI-CAT-II)ePoster presentation: 1534eTiPAndrés J. MuñozN/ASub-analysis of a Phase 2 study investigating amrecibart and cenvacibart for the prevention of contact-mediated VTE in participants with active cancer undergoing peripherally inserted central catheter (PICC) placement (ROXI-CATH)Poster presentation: 1468PJeffrey I. ZwickerMonday
October 26,
12:00-12:45Population pharmacokinetic/pharmacodynamic modeling of REGN7508Cat in patients with a PICC from ROXI-CATH who have active cancer supports maximal Factor XI pathway inhibitionPoster presentation: 3968PJeffrey I. ZwickerSaturday
October 24,
12:00-12:45
The potential uses of neoadjuvant Libtayo in CSCC, ubamatamab, cenvacibart and amrecibart described above are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

About Regeneron in Cancer 
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.  

Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.  

To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. 

About Libtayo  
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), CSCC that is advanced or at high risk of recurrence, advanced NSCLC and advanced cervical cancer.

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:

Adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC): that has spread or cannot be cured by surgery or radiation, orto help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation. Adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene. It is not known if Libtayo is safe and effective in children.

IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS

What is the most important information I should know about LIBTAYO?
LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest painIntestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tendernessLiver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normalHormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulnessKidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetiteSkin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodesProblems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruisingInfusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swellingRejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have hadComplications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupushave received an organ or tissue transplant, including corneal transplanthave received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)have received radiation treatment to your chest areahave a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndromeare pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby
Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatmentYou should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this timeTell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of   LIBTAYO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of LIBTAYO when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC, or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia).

The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching.

The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite.

These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

Please see full Prescribing Information, including Medication Guide.

About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara®, Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz® (pozelimab-bbfg) and Pasatru™ (garetosmab-grts). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Libtayo® (cemiplimab) as an adjuvant or neoadjuvant treatment for high-risk cutaneous squamous cell carcinoma, Regeneron’s Factor XI antibodies (cenvacibart and amrecibart) as a potential approach to reducing thrombosis in patients with cancer, and the other clinical programs discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as those referenced above; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Contacts:

Media Relations 
Taylor Ramsey Skott
Tel: +1 914-409-2381
[email protected] Relations
Mark Hudson
Tel: +1 914-847-3482
[email protected]
2026-10-02 20:04 22d ago
2026-10-02 13:19 22d ago
Regeneron Highlights Promising Ovarian Cancer, Muscle Preservation Trial Data
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) on Thursday shared clinical trial results for two investigational therapies targeting recurrent ovarian cancer and muscle loss prevention during weight management.

The biotechnology company presented Phase 1/2 data for ubamatamab in low-grade serous ovarian cancer alongside Phase 2 COURAGE trial findings for trevogrumab combined with Novo Nordisk A/S’s (NYSE:NVO) semaglutide.

Strong Response Rates in Ovarian CancerAt the International Gynecologic Cancer Society 2026 Annual Global Meeting, the firm presented initial data for ubamatamab, a bispecific antibody designed to connect cancer cells with T cells to trigger local activation.

LGSOC represents up to 10% of serous ovarian cancers and currently lacks effective treatment options for recurrent cases.

Read Next

Among patients receiving 800 mg monotherapy doses, the drug achieved a 73% objective response rate, an 11-month median progression-free survival, and a 9-month median duration of response.

Consequently, the company is enrolling a potentially registrational trial and preparing to consult with the U.S. Food and Drug Administration regarding a confirmatory Phase 3 study.

Safety assessments across 19 patients showed treatment-emergent adverse events in all participants, though cytokine release syndrome cases were limited to Grade 1 or 2.

Muscle Preservation in Weight LossDuring a Scientific Symposium at the European Association for the Study of Diabetes Annual Meeting, the company highlighted Phase 2 COURAGE trial results for trevogrumab.

The anti-myostatin therapy was paired with semaglutide to prevent lean mass loss in adults living with obesity.

Lower trevogrumab doses preserved up to 50.7% of lean mass relative to semaglutide monotherapy and retained nearly 70% of thigh muscle volume.

Broader Pipeline ExpansionRegeneron plans to launch a Phase 2 study testing trevogrumab with GLP-1 therapies in older adults with obesity and reduced muscle strength.

Additionally, partner Hansoh shared Phase 3 results in Chinese patients for olatorepatide, a novel GLP-1/GIP receptor agonist licensed exclusively to the drugmaker outside Greater China.

REGN Price Action: Regeneron Pharmaceuticals shares were up 0.10% to $735.54 at the time of publication on Friday, according to Benzinga Pro data.

Photo: Shutterstock

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2026-10-02 17:35 22d ago
2026-10-02 06:15 22d ago
Reviewing Rigel Pharmaceuticals (NASDAQ:RIGL) & Regeneron Pharmaceuticals (NASDAQ:REGN)
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Rigel Pharmaceuticals (NASDAQ:RIGL – Get Free Report) and Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) are both healthcare companies, but which is the better investment? We will compare the two businesses based on the strength of their risk, profitability, dividends, analyst recommendations, earnings, institutional ownership and valuation.

Valuation and Earnings This table compares Rigel Pharmaceuticals and Regeneron Pharmaceuticals”s top-line revenue, earnings per share (EPS) and valuation.

Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Rigel Pharmaceuticals $294.28 million 2.95 $367.02 million $16.32 2.88 Regeneron Pharmaceuticals $14.34 billion 5.27 $4.50 billion $40.46 18.16 Regeneron Pharmaceuticals has higher revenue and earnings than Rigel Pharmaceuticals. Rigel Pharmaceuticals is trading at a lower price-to-earnings ratio than Regeneron Pharmaceuticals, indicating that it is currently the more affordable of the two stocks. Profitability This table compares Rigel Pharmaceuticals and Regeneron Pharmaceuticals’ net margins, return on equity and return on assets.

Net Margins Return on Equity Return on Assets Rigel Pharmaceuticals 116.30% 22.95% 17.19% Regeneron Pharmaceuticals 27.86% 13.47% 10.34% Risk and Volatility Rigel Pharmaceuticals has a beta of 1.19, suggesting that its stock price is 19% more volatile than the S&P 500. Comparatively, Regeneron Pharmaceuticals has a beta of 0.16, suggesting that its stock price is 84% less volatile than the S&P 500.

Analyst Ratings This is a summary of current ratings and target prices for Rigel Pharmaceuticals and Regeneron Pharmaceuticals, as reported by MarketBeat.com.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Rigel Pharmaceuticals 0 3 4 0 2.57 Regeneron Pharmaceuticals 0 9 16 1 2.69 Rigel Pharmaceuticals presently has a consensus price target of $59.00, indicating a potential upside of 25.61%. Regeneron Pharmaceuticals has a consensus price target of $809.50, indicating a potential upside of 10.16%. Given Rigel Pharmaceuticals’ higher probable upside, equities research analysts plainly believe Rigel Pharmaceuticals is more favorable than Regeneron Pharmaceuticals.

Insider & Institutional Ownership 66.2% of Rigel Pharmaceuticals shares are held by institutional investors. Comparatively, 83.3% of Regeneron Pharmaceuticals shares are held by institutional investors. 10.5% of Rigel Pharmaceuticals shares are held by insiders. Comparatively, 7.0% of Regeneron Pharmaceuticals shares are held by insiders. Strong institutional ownership is an indication that large money managers, endowments and hedge funds believe a company is poised for long-term growth.

Summary Regeneron Pharmaceuticals beats Rigel Pharmaceuticals on 9 of the 15 factors compared between the two stocks.

(Get Free Report)

Rigel Pharmaceuticals, Inc., a biotechnology company, engages in discovering, developing, and providing therapies that enhance the lives of patients with hematologic disorders and cancer. The company’s commercialized products include Tavalisse, an oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia; Rezlidhia, a non-intensive monotherapy for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test; and GAVRETO, a once daily, small molecule, oral, kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, as well as for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer. It also develops R289, an oral IRAK1/4 Inhibitor, which is in Phase 1b clinical trials for the treatment of hematology-oncology, autoimmune, and inflammatory diseases; and a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, the company has product candidates in clinical development with partners BerGenBio ASA and Daiichi Sankyo. The company has strategic development collaboration with The University of Texas MD Anderson Cancer Center for the development of REZLIDHIA (Olutasidenib) in acute myeloid leukemia (AML) and other hematologic cancers. The company was incorporated in 1996 and is headquartered in South San Francisco, California.

About Regeneron Pharmaceuticals (Get Free Report)

Regeneron Pharmaceuticals, Inc. discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases worldwide. The company's products include EYLEA injection to treat wet age-related macular degeneration and diabetic macular edema; myopic choroidal neovascularization; diabetic retinopathy; neovascular glaucoma; and retinopathy of prematurity. It also provides Dupixent injection to treat atopic dermatitis and asthma in adults and pediatrics; Libtayo injection to treat metastatic or locally advanced cutaneous squamous cell carcinoma; Praluent injection for heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in adults; REGEN-COV for covid-19; and Kevzara solution for treating rheumatoid arthritis in adults. In addition, the company offers Inmazeb injection for infection caused by Zaire ebolavirus; ARCALYST injection for cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and muckle-wells syndrome; and ZALTRAP injection for intravenous infusion to treat metastatic colorectal cancer; and develops product candidates for treating patients with eye, allergic and inflammatory, cardiovascular and metabolic, infectious, and rare diseases; and cancer, pain, and hematologic conditions. It has collaboration with Mammoth Biosciences, Inc. to research, develop and commercialize in vivo CRISPR-based gene editing therapies for multiple tissues and cell types. The company was incorporated in 1988 and is headquartered in Tarrytown, New York.

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2026-10-02 15:08 22d ago
2026-10-02 10:46 22d ago
Sanofi, Regeneron Expand Immunology Alliance With New Antibodies
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Key Takeaways SNY and REGN expand their alliance to co-develop four long-acting antibodies targeting type II inflammation.REGN will receive $1B upfront and could earn up to $7B in development and regulatory milestones.The companies will equally share development and commercialization costs and future global profits. Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals (REGN - Free Report) announced that they have expanded their existing longstanding antibody collaboration to include four next-generation, long-acting antibodies targeting type II inflammation.

More on the Latest SNY/REGN AgreementPer the expanded agreement, the companies will co-develop and co-commercialize four Regeneron-invented antibodies targeting interleukin-13 (IL-13), IL-4xIL-13 bispecific, interleukin-4 (IL-4) and interleukin-4 receptor alpha (IL-4Rα).

One of the programs, REGN20423, is a long-acting IL-13 monoclonal antibody currently being evaluated in a phase I study for atopic dermatitis. The other three antibodies are expected to enter clinical studies in 2027.

Regeneron will also have an option to include Sanofi's investigational candidate, lunsekimig, a bispecific nanobody therapy targeting TSLP and IL-13, in the latest collaboration after completion of its phase III studies in chronic obstructive pulmonary disease.

REGN is entitled to receive an upfront payment of $1 billion from SNY. It is also eligible to receive up to $7 billion in additional development, regulatory and commercial milestone payments.

Both companies will equally share development and commercialization costs and future profits from the potential products globally. Regeneron will lead research and development activities, while Sanofi will oversee global commercial efforts.

Sanofi and Regeneron also agreed to settle their prior collaboration-related litigation.

The expanded collaboration builds on the companies' more than 20-year alliance, which has established Dupixent as a widely used treatment for diseases driven by type II inflammation. Per the press release, more than 1.5 million people are currently receiving Dupixent across nine indications.

The existing profit-sharing agreement for Dupixent will remain unchanged.

Dupixent Demand Drives SNY’s Top-Line GrowthDupixent currently holds the number one new-to-brand prescription market share across all its approved indications in the United States. It is approved in several countries in one or more indications, covering nine distinct diseases, driven partly by type II inflammation.

The drug is presently approved for severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid and allergic fungal rhinosinusitis.

Dupixent generated sales of €9.3 billion in the first half of 2026, up 28.6% year over year. Second-quarter sales jumped 37.6% to €5.2 billion, crossing the €5 billion quarterly threshold for the first time. Dupixent’s strong sales growth is being driven by demand across all geographies, newly approved indications and demographics. Sanofi expects Dupixent to achieve around €25 billion in sales in 2030.

While SNY records Dupixent sales, Regeneron registers its share of profits/losses in connection with the global sales of the drug.

New Medicines Strengthen Sanofi’s PortfolioBesides Dupixent, Sanofi is also seeing a good uptake of its new medicines like novel recombinant factor VIII therapy, Altuviiio and cancer drugs, Ayvakit and Sarclisa. These drugs remain important for broadening the company’s growth base.

Sales of its new and acquired drugs rose 48.3% to €1.3 billion during the second quarter of 2026, led by Altuviiio, Ayvakit and Sarclisa. Beyfortus (in partnership with AstraZeneca (AZN - Free Report) ]) achieved blockbuster sales in its first full year of sales in 2024 and continues its expansion into new geographies. Altuviiio achieved blockbuster sales in 2025, and Ayvakit, added from the Blueprint Medicines acquisition, is expected to become the next blockbuster drug in 2026.

Sanofi expects its new and acquired products to generate approximately €10 billion in sales by 2030.
2026-10-01 22:00 22d ago
2026-10-01 15:50 23d ago
Regeneron Pharmaceuticals, Inc. (REGN) Discusses Expanded Collaboration on Next-Generation Long-Acting Immunology Antibodies Transcript
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals, Inc. (REGN) Discusses Expanded Collaboration on Next-Generation Long-Acting Immunology Antibodies October 1, 2026 8:00 AM EDT

Company Participants

Ryan Crowe - Senior Vice President of Investor Relations & Strategic Analysis
François-Xavier Roger - Executive VP & CFO
Leonard Schleifer - Co-Founder, President, CEO & Co-Chairman
Belen Garijo Lopez - CEO & Director
George Yancopoulos - Co-Founder, President, Chief Scientific Officer & Co-Chairman
Manuela Buxo - Executive VP & Head of Specialty Care
Paulo Fontoura - EVP, Global Head of Research & Development (Pharma)

Conference Call Participants

Evan Seigerman - BMO Capital Markets Equity Research
Luisa Hector - Joh. Berenberg, Gossler & Co. KG, Research Division
Nicholas Lorusso - TD Cowen, Research Division
Victor Floch - BNP Paribas, Research Division
Florent Cespedes - ODDO BHF Corporate & Markets, Research Division
Akash Tewari - Jefferies LLC, Research Division
Naresh Chouhan - Intron Health Advisors Ltd
Salveen Richter - Goldman Sachs Group, Inc., Research Division
Richard Vosser - JPMorgan Chase & Co, Research Division
Alexandria Hammond - Wolfe Research, LLC
Graham Glyn Parry - Citigroup Inc., Research Division

Presentation

Operator

Conference call announcing their expanded collaboration to include next-generation Type 2 medicines. My name is Michelle, and I'll be your operator for today's call. [Operator Instructions] Please note this call is being recorded. I would now like to turn the call over to Ryan Crowe, Senior Vice President, Investor Relations at Regeneron.

Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis

Thank you, Michelle. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for joining today's call to announce the expansion of the collaboration between Regeneron and Sanofi. We have members from the management teams from both Regeneron and Sanofi here today. But before we get started with introductions and our meeting agenda, both companies will read their forward-looking statements.

For Regeneron investors, I would like to remind
2026-10-01 19:34 23d ago
2026-10-01 13:29 23d ago
Regeneron And Sanofi Announce A Win-Win Collaboration Expansion
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron and Sanofi announced a strategic expansion of their antibody collaboration, targeting IL-4/IL-13 pathways for next-generation inflammation and immunology therapies. The deal grants REGN $1B upfront and up to $7B in milestones, with a 50:50 global profit split for new assets, enhancing alignment and commercial potential. REGN and SNY now have several shots on goal to address Dupixent loss-of-exclusivity and emerging long-acting competitors, with key assets potentially launching from 2030 onward.
2026-10-01 17:07 23d ago
2026-10-01 10:50 23d ago
Lilly vs. Novo: Inside the Milan EASD Showdown and the ETFs Poised to Win
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Key Takeaways LLY and Novo unveiled new clinical data at EASD, intensifying competition in the weight loss market. LLY's retatrutide showed 34.9% of patients lost at least 25% of body weight at the highest dose. ETFs like OZEM offer diversified exposure to companies benefiting from the expanding GLP-1 market. The 2026 European Association for the Study of Diabetes (“EASD”) annual meeting in Milan has become the stage for a fierce data duel between Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) . Both pharma giants unveiled new clinical evidence to bolster their positions in the booming weight-loss drug market. 

Lilly presented full Phase 3 data for its triple-G drug retatrutide, showing that 34.9% of patients on the highest dose lost at least 25% of their body weight, alongside a new combination drug, EloraTZP, that delivered up to 23.3% weight loss in patients with obesity and type 2 diabetes. Novo countered this with real-world data suggesting that Ozempic is associated with a 6% lower risk of major cardiovascular events compared with Lilly’s Mounjaro.

This flurry of competition underscores a critical reality for investors: the rising tide of clinical validation is lifting the entire GLP-1 market.

For those seeking exposure to the weight-loss drug market without getting exposed to single-stock risk, healthcare exchange-traded funds (ETFs), particularly those focused on GLP-1, offer a strategic gateway. 

Before identifying these ETFs, it is crucial to understand where the obesity and diabetes care market is heading and the roles Lilly and Novo play in shaping it, creating opportunities across the broader healthcare investment landscape.

GLP-1 Market Trends: LLY, NVO & BeyondEli Lilly and Novo Nordisk stand at the center of the diabetes and weight-loss drug market, with both companies racing to capture more shares of the global market for anti-obesity medications, projected to exceed $100 billion by 2030. 

The competitive intensity is rising. Eli Lilly's triple-agonist retatrutide has drawn considerable attention for its potential best-in-class efficacy, while Novo Nordisk continues to defend its first-mover advantage in the injectable GLP-1 space through its oral Wegovy launch and pipeline expansion.

Beyond these two leaders, several other prominent pharmaceutical and biotech companies are actively shaping the competitive landscape. Pfizer (PFE - Free Report) has re-entered the obesity race with its own oral GLP-1 candidate. To bolster its position in the anti-obesity drug market, it completed its massive $10 billion acquisition of Metsera last year. 

Amgen (AMGN - Free Report) is advancing MariTide, a long-acting weight-loss injectable with a differentiated mechanism that could offer less frequent dosing.

Regeneron Pharmaceuticals (REGN - Free Report) is exploring combination approaches targeting muscle preservation alongside fat loss, addressing a key concern for patients and physicians. The company in-licensed a dual GLP-1/GIP receptor agonist (similar to the mechanism used in tirzepatide) in 2025 to offer its own monotherapy solution for weight loss.

What Lies Ahead for the Weight-Loss Market?

The interconnection between obesity and type 2 diabetes is the biological foundation driving the weight-loss market’s expansion. Currently, more than 27% of adults globally are eligible for GLP-1 receptor agonists for weight management, based on pooled data from 99 countries, per a study conducted by Researchers from Mass General Brigham, Washington University School of Medicine in St. Louis, and Emory University’s Rollins School of Public Health (published in January 2026).  This study's authors noted that overall eligibility is driven by the steadily increasing prevalence of obesity globally.

This surely reflects the growing addressable population for GLP-1 medication. The entry of oral formulations has further accelerated adoption by removing the needle barrier, with telehealth providers reporting that patients are choosing pills over injections “by a huge factor.”

As a result, pharma and biotech stocks exposed to the GLP-1 market should continue to rally in the days ahead.

Healthcare ETFs to WinAgainst the current backdrop, a diversified ETF strategy should allow investors to capture the sector’s growth while mitigating exposure to any single drug’s clinical or competitive setback, taking into account the scientific complexity, regulatory hurdles and commercial execution risk inherent in this space. Thus, investors eager to gain exposure to the GLP-1 market may consider adding the following ETFs to their portfolios that are poised to gain from the expanding GLP-1 market: 

Roundhill GLP-1 & Weight Loss ETF (OZEM - Free Report)

This fund, with net assets worth $57.8 million, offers exposure to 25 companies involved in weight-loss drug making. LLY holds the first spot in this fund, with 12.67% weightage, while NOVO holds the second position with 11.07% weightage. 

PFE holds the third spot in this fund, with 11.48% weightage, while AMGN holds the ninth position with 4.36% weightage. OZEM charges 59 basis points in fees. 

Tema Heart & Health ETF (HRTS - Free Report)

This fund, with net assets worth $54.2 million, offers exposure to 46 companies advancing prevention and treatment across chronic conditions, including heart disease, diabetes and obesity. LLY holds the first spot in this fund, with 11.44% weightage, while NOVO holds the fifth position with 4.16% weightage. 

HRTS charges 75 basis points (bps) in fees. 

Amplify Weight Loss Drug & Treatment ETF (THNR - Free Report)

This fund, with net assets worth $5.8 million, offers exposure to 20 global companies expected to economically benefit from weight loss drug development. LLY holds the first spot in this fund, with 10.07% weightage, while NOVO holds the second position with 8.42% weightage. 

AMGN holds the fourth spot in this fund, with 5.75% weightage, while PFE holds the fifth position with 5.38% weightage. REGN holds the eighth spot with 4.64% weightage. THNR charges 59 in fees. 
 
2026-10-01 17:07 23d ago
2026-10-01 11:02 23d ago
Regeneron, Sanofi Expand Alliance in Deal Worth Up to $8 Billion
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Amylyx Stock: Why the Full Pipeline Story MattersRegeneron Pharmaceuticals NASDAQ: REGN and Sanofi said they are expanding their long-running collaboration to develop and commercialize next-generation medicines for type 2 inflammatory diseases, adding four Regeneron-originated antibody programs and establishing a new equal-sharing economic framework for the assets.

Under the agreement, Sanofi will pay Regeneron $1 billion upfront and could pay up to $7 billion more upon specified development, regulatory and commercial milestones. The companies will share global development and commercialization costs equally and split global profits 50-50 for the new alliance medicines.

Get REGN alerts:

Ozempic, Mounjaro, Wegovy, or Zepbound? This ETF Holds Them AllSanofi will continue to record net sales under the companies’ existing reporting practice. François Roger, Sanofi’s executive vice president and chief financial officer, said the transaction is expected to be reflected in both companies’ fourth-quarter 2026 financial results.

Four Regeneron Antibodies Added to Alliance Regeneron is contributing four fully human, long-acting antibody programs to the expanded alliance. The lead program is an IL-13 antibody currently in clinical development for atopic dermatitis. The other three programs are preclinical: an IL-4/IL-13 bispecific antibody, an IL-4 receptor alpha antibody and an IL-4 antibody.

Pfizer Adds to Its Big Bet on Weight Loss DrugsGeorge Yancopoulos, Regeneron’s co-founder, board co-chair, president and chief scientific officer, said the long-acting IL-13 antibody has demonstrated “remarkable long-lived pharmacokinetic properties” in the clinic. Registrational studies in atopic dermatitis are expected to begin in late 2027 or early 2028.

The IL-13 program is designed for a target dosing interval of at least every three to six months, according to Yancopoulos. He said the other three programs are expected to be ready for clinical development next year.

The expanded agreement also gives Regeneron an option to bring Sanofi’s lunsekimig, an IL-13/TSLP Nanobody, into the alliance depending on Phase II results in chronic obstructive pulmonary disease. Sanofi’s Manuela Buxo, executive vice president and head of specialty care, said the companies intend to assess COPD data before deciding whether to advance the molecule in other indications.

Building on DUPIXENT Platform The companies said the new programs will use the global development and commercial infrastructure built around DUPIXENT. Leonard Schleifer, Regeneron’s co-founder, board co-chair, president and chief executive officer, said the existing platform serves more than 1.5 million DUPIXENT patients worldwide.

Schleifer said Sanofi recorded second-quarter 2026 global net sales of €5.2 billion for DUPIXENT, placing the treatment on an annualized run rate above €20 billion across nine indications. Yancopoulos said DUPIXENT is approved by the U.S. Food and Drug Administration for nine diseases affecting the skin, gut and respiratory system, for patients from six months of age through older adults.

Belén Garijo, Sanofi’s chief executive officer, said only about 20% of eligible U.S. patients currently receive advanced therapies and that the market could nearly double over the next five years. She cited more than 2.5 million U.S. patients with moderate-to-severe atopic dermatitis and said Sanofi projects the U.S. atopic dermatitis market could reach about $20 billion in sales by 2032.

Garijo said the companies see a need for longer dosing intervals without compromising efficacy or safety, and plan to use their established provider relationships, patient-support infrastructure, supply capabilities and market-access experience to support the new medicines if approved.

Governance and Intellectual Property Outlook The companies also outlined a revised governance structure. Regeneron will have final decision-making authority for development, while Sanofi will retain final commercial decision rights, including pricing and access. Garijo said Regeneron will have increased participation in key payer engagements.

The prior agreement covering DUPIXENT remains unchanged, including its profit-sharing arrangement, Roger said. He said DUPIXENT’s U.S. loss of exclusivity is currently expected in March 2031, while Sanofi is working to extend protection by several years. He cautioned that there is no certainty that such an extension will be obtained.

Garijo said the agreement also resolves litigation between the companies. She described the expanded arrangement as providing clearer governance, greater transparency and a stronger framework for advancing new medicines.

“This strengthened alliance gives our next-generation programs the best opportunity to move rapidly through development,” Schleifer said, adding that the companies aim to extend their leadership in type 2 inflammatory diseases.

About Regeneron Pharmaceuticals (NASDAQ:REGN)Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses human genetics, antibody technology and other biological research platforms to develop treatments in areas including eye diseases, cancer, cardiovascular and metabolic disorders, inflammatory diseases, infectious diseases and rare conditions.

Regeneron's marketed products include EYLEA and EYLEA HD for certain retinal diseases; Dupixent, developed and commercialized with Sanofi, for multiple allergic and inflammatory conditions; Libtayo for certain cancers; Praluent for high cholesterol; Kevzara for rheumatoid arthritis and other inflammatory diseases; Evkeeza for homozygous familial hypercholesterolemia; and Veopoz for a rare immune-mediated disorder.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-10-01 17:07 23d ago
2026-10-01 11:30 23d ago
Phase 2 COURAGE Trial Confirms Trevogrumab Prevents Lean Mass and Muscle Loss During GLP-1 Receptor Agonist-induced Weight Loss
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
In a predefined MRI substudy, trevogrumab prevented 70% of muscle loss associated with semaglutide treatment 

A pre-specified subgroup analysis found that patients meeting the low lean mass definition for sarcopenia had greater loss of lean mass with semaglutide, and more preservation with trevogrumab

Findings were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting and is in press with The Lancet

TARRYTOWN, N.Y., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new results from the Phase 2 COURAGE trial evaluating trevogrumab (anti-GDF8/anti-myostatin) for its potential to prevent lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in people living with obesity. The results of the trial were presented during a Scientific Symposium at the European Association for the Study of Diabetes (EASD) Annual Meeting and is in press with The Lancet. Building on these positive findings, Regeneron is planning to initiate a Phase 2 trial evaluating trevogrumab in combination with GLP-1 receptor agonist-based therapies in older adults with obesity and decreased muscle mass and/or strength.

“COURAGE demonstrated that trevogrumab, which blocks myostatin, can preserve lean mass and muscle during semaglutide-induced weight loss,” said Julio Rosenstock, M.D., Lead Principal Investigator of the COURAGE trial and Clinical Professor of Medicine, University of Texas Southwestern Medical Center, Dallas. “These results, sustained through a full year of treatment, were further validated by MRI measurements of muscle volume supporting continued clinical development of trevogrumab and future research into muscle preservation as part of obesity care.”

COURAGE investigated the quality of weight loss in people living with obesity (BMI ≥30 kg/m2) in two independent portions over 52 weeks. A higher-dose portion evaluated trevogrumab (200 mg or 400 mg) in combination with semaglutide 2.4 mg for 26 weeks compared to semaglutide alone, and then trevogrumab compared to placebo alone for an additional 26 weeks after semaglutide was discontinued. The trial also included a treatment arm with semaglutide, trevogrumab and an Activin-A inhibitor for which the results were previously presented.

A lower-dose portion evaluated trevogrumab (25 mg or 75 mg) in combination with semaglutide 2.4 mg compared to semaglutide monotherapy for 52 weeks. The results in this portion replicated the findings of the higher-dose portion, with the greatest reduction in lean mass occurring during the period of most rapid weight loss that was observed in the first six months of treatment. While lower-dose trevogrumab did not meaningfully enhance the weight loss achieved with semaglutide alone, it preserved lean mass at both 26 and 52 weeks (the primary endpoint), compared to placebo, as outlined in the table below:

Percent change in lean mass from baseline as measured by DXAArm26 weeks52 weeksPlacebo + semaglutide -6.7% (95% CI: -7.9 to -5.5)-7.3% (95% CI: -8.8 to -5.8)Trevogrumab 25 mg + semaglutide-4.7% (95% CI: -5.5 to -3.9)29.9% lean mass preservation*

-5.8% (95% CI: -6.8 to -4.7)20.5% lean mass preservation*

Trevogrumab 75 mg + semaglutide-3.3% (95% CI: -4.1 to -2.4)50.7% lean mass preservation*

-4.2% (95% CI: -5.3 to -3.1)42.5% lean mass preservation*

*Relative to placebo + semaglutide

Among participants with evaluable MRI data, lower dose trevogrumab preserved almost 70% of the thigh muscle that would have been otherwise lost with semaglutide treatment alone, as outlined in the table below:

Absolute change from baseline in fat free muscle volume (mean ± standard error) as measured by MRIArm26 weeks52 weeksPlacebo + semaglutide -0.88 ± 0.21-1.03 ± 0.22Trevogrumab 25 mg + semaglutide-0.32 ± 0.1463.6% muscle preservation*

-0.29 ± 0.1271.8% muscle preservation*

Trevogrumab 75 mg + semaglutide-0.24 ± 0.1372.7% muscle preservation*

-0.32 ± 0.1368.9% muscle preservation*

*Relative to placebo + semaglutide

The lower doses of trevogrumab were generally well tolerated, with 77% of participants experiencing at least one adverse event (AE), compared with 82% of those who were treated with placebo. The most common AEs occurring in ≥10% of patients were nausea, constipation, diarrhea and vomiting.

Also presented at EASD was a pre-specified subgroup analysis of participants with low lean mass (LLM) at baseline. Compared to patients without LLM at baseline, these patients experienced a greater loss of lean mass with semaglutide alone and numerically more preservation of lean mass in combination with trevogrumab. LLM was defined using the imaging component of the sarcopenia definition established by the Foundation for the National Institutes of Health (appendicular lean mass relative to BMI, measured by DXA).

“As GLP-1 receptor agonist-based medicines become foundational to obesity care, it is becoming increasingly recognized that the associated muscle loss is an increasing concern – particularly for people with sarcopenia, older adults and others where frailty is a real concern,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine, Regeneron. “Our COURAGE trial not only confirms this concern about muscle loss but also shows that trevogrumab can be part of the solution, addressing not the quantity, but rather the quality, of weight loss. It’s an approach we’re building across our growing pipeline.”

Additionally, Hansoh presented data from their Phase 3 trial in Chinese patients evaluating olatorepatide for the treatment of adults with obesity or who are overweight. Olatorepatide is a novel GLP-1/GIP receptor agonist for which Regeneron has exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau as part of a strategic in-licensing agreement.

The safety and efficacy of trevogrumab and olatorepatide have not been evaluated by any regulatory authority.

About Regeneron in Obesity
Obesity is a complex, multifaceted disease and a growing public health concern that affects more than a billion people worldwide. Despite the revolutionary impact of GLP-1 receptor agonists (GLP-1RAs) on weight loss, the quality of this weight loss can be negatively impacted because these agents can cause profound muscle loss.
At Regeneron, we are developing a pipeline focused on the quality of weight reduction. We have several independent approaches focused on promoting and preserving muscle during weight loss, so as to increase the amount of fat loss since adiposity is the principal driver of comorbidities and metabolic diseases associated with obesity. In addition, Regeneron has an extensive pipeline of agents to address some of these co-morbidities and metabolic diseases, which have the potential to be combined with GLP-1RAs. The combination of our science, pipeline, research and clinical innovation uniquely positions us to make a meaningful difference in obesity and obesity-related diseases.  

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media 
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation the clinical programs discussed or referenced in this press release evaluating trevogrumab (anti-GDF8/anti-myostatin) in combination with semaglutide or other GLP-1 receptor agonist-based therapies to prevent lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss as well as olatorepatide as a monotherapy for the treatment of adults with obesity or who are overweight; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as those referenced above; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).
2026-10-01 17:07 23d ago
2026-10-01 11:35 23d ago
Ubamatamab (MUC16xCD3) Shows a High Rate of Durable Responses in Initial Study of Patients with Advanced Low-Grade Serous Ovarian Cancer (LGSOC)
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
LGSOC is a biologically distinct variant of ovarian cancer, with limited treatment options, that is generally less responsive to conventional chemotherapy

Results presented in a late-breaking plenary session at IGCS demonstrated a 73% objective response rate and 11-month median progression-free survival in 11 patients with recurrent and heavily pre-treated LGSOC treated with the highest dose of ubamatamab in the trial  

Regeneron has been enrolling a dedicated LGSOC cohort at this dose and will advance ubamatamab into a confirmatory Phase 3 trial of this lethal cancer with limited treatment options

TARRYTOWN, N.Y., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first results for the investigational ubamatamab in patients with low-grade serous ovarian cancer (LGSOC). The data are from an ongoing Phase 1/2 trial in recurrent platinum-resistant high- or low-grade serous ovarian cancer that were presented in a late-breaking plenary oral session at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting. Ubamatamab is a MUC16xCD3 bispecific antibody designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation. Based on these preliminary trial results, Regeneron has been enrolling a single-arm, potentially registrational LGSOC trial and will be discussing the data with the U.S. Food and Drug Administration (FDA) in the coming months. Regeneron is also planning to initiate a confirmatory, randomized, controlled Phase 3 trial to support the use of ubamatamab in LGSOC.

LGSOC is a biologically distinct variant from the more common high-grade serous ovarian cancer (HGSOC), comprising up to 10% of serous ovarian cancer, with typically uniformly high MUC16 expression and limited treatment options. The disease often affects younger women and is characterized by slower-growing tumors than those seen in HGSOC, but frequently recurs and is less responsive to conventional chemotherapy with few treatment options. LGSOC has a median overall survival of approximately seven years from initial diagnosis, compared to approximately four years for HGSOC. In recurrent advanced LGSOC, historical trial data have shown that objective response rates (ORRs) generally remain below 15% with chemotherapy and endocrine therapy, while the only approved therapy has an ORR of 44% in biomarker-selected patient populations (representing about 30% of the overall LGSOC population).

“The high rate of durable responses observed thus far with ubamatamab in low-grade serous ovarian cancer, without requiring biomarker selection, are highly encouraging and reinforce our excitement about MUC16 as a new therapeutic target in this difficult-to-treat disease,” said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. “This initial clinical evidence highlights the potential of our bispecific approach to bring a differentiated and first-in-class treatment option to patients in need. We are pleased with the safety profile of the drug as well, and are eager to build on these findings through our ongoing trial and planned confirmatory Phase 3 trial.”

Data presented at IGCS focused on the LGSOC subset of 19 patients who had received a median of four prior lines of therapy and were dosed with intravenous ubamatamab ranging from 3 to 800 mg weekly or every three weeks. Ubamatamab was given either as monotherapy or in combination with Libtayo® (cemiplimab).

Included in the presentation were 11 patients treated with 800 mg of ubamatamab monotherapy, eight treated weekly and three treated every three weeks. Results at the 800 mg doses showed a:

73% ORR (95% Confidence Interval [CI]: 39.0 to 94.0), with all responses being partial responses9-month median duration of response (95% CI: 6.9 to not estimable [NE]), per Kaplan-Meier estimate11-month median progression-free survival (95% CI: 3.0 to NE), per Kaplan-Meier estimate Safety was assessed across all 19 patients in the LGSOC subset. Treatment-emergent adverse events (TEAEs) occurred in 100% of participants (n=19). Cytokine release syndrome occurred in 90% of participants (n=17), all of which were Grade 1 or 2. Serious TEAEs grade 3 or higher occurred in 21% (n=4) of participants and treatment-related adverse events (TRAEs) occurred in 74% of participants (n=14). Grade 3 or higher TRAEs included neutropenia (21%; n=4), anemia (11%; n=2), increased alanine aminotransferase (11%; n=2), increased aspartate aminotransferase (11%; n=2), abdominal pain (5%; n=1) and ileus (5%; n=1). Most adverse events occurred during the step-up dosing period. One participant discontinued treatment due to a stroke considered unrelated to ubamatamab treatment; no TEAEs resulted in death.

The potential uses of ubamatamab described above are investigational, and its safety and efficacy have not been evaluated by any regulatory authority.

About the Trial
The ongoing, open-label, Phase 1/2 trial is evaluating ubamatamab alone and in combination with Libtayo in adult patients with recurrent platinum-resistant ovarian cancer and other recurrent MUC16-expressing cancers.

The Phase 1 portion of the trial is primarily assessing safety, tolerability, dose-limiting toxicities and pharmacokinetics of ubamatamab, with efficacy evaluated as a secondary endpoint through measures such as ORR, duration of response and progression-free survival. The Phase 2 portion is evaluating the anti-tumor activity of ubamatamab, primarily through ORR, while continuing to assess safety and tolerability.

A prospective, dedicated, potentially registrational cohort in the Phase 2 portion of this trial is evaluating ubamatamab 800 mg monotherapy every three weeks in up to 100 patients with recurrent LGSOC and is currently enrolling. If you are interested in learning more about this trial, please contact us ([email protected], +1 844 734 6643), or visit our clinical trial website.

About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic cancers and remains a leading cause of cancer-related mortality among women. It arises from the uncontrolled growth of abnormal cells in the ovary and is frequently diagnosed at an advanced stage, when disease has spread beyond the ovary. In 2026, an estimated 21,010 new cases of ovarian cancer were expected to be diagnosed in the U.S., and approximately 12,450 women were expected to die from the disease. Despite advances in treatment, ovarian cancer remains a significant unmet medical need, with many patients ultimately experiencing disease recurrence and progression. 

LGSOC is a distinct form of ovarian cancer that occurs in younger women and comprises up to 10% of new epithelial ovarian cancer cases. While LGSOC tumor cells tend to grow and divide more slowly than those seen in high-grade serous ovarian cancer, the disease frequently recurs and is less responsive to conventional chemotherapy. LGSOC has a median overall survival of approximately seven years from initial diagnosis, compared to approximately four years for HGSOC. Although endocrine therapy and targeted therapies are used in selected patients, treatment options remain limited for many people with recurrent disease.

About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.

Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.

About Libtayo    
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer.  

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab.   

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.     

What is the most important information I should know about LIBTAYO?  
LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. 

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:  

Lung problems: cough, shortness of breath, or chest pain   Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness   Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal   Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness   Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite   Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes   Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising   Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling   Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had   Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications   Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects. 

  Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus   have received an organ or tissue transplant, including corneal transplant    have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)   have received radiation treatment to your chest area   have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome   are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby   Females who are able to become pregnant:  

Your healthcare provider will give you a pregnancy test before you start treatment   You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time   Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO   are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO    Tell your healthcare provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements. 

  The most common side effects of LIBTAYO when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC, or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching. The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite. 

  These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296. 

  Please see full Prescribing Information, including Medication Guide.

About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara®, Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz® (pozelimab-bbfg) and Pasatru™ (garetosmab-grts). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation ubamatamab (MUC16xCD3 bispecific antibody), Libtayo® (cemiplimab), and the other clinical programs discussed or referenced in this press release; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as ubamatamab as a monotherapy or in combination with Libtayo® (cemiplimab) for the treatment of low-grade serous ovarian cancer; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as ubamatamab); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as ubamatamab) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Contacts:

Media Relations 
Taylor Ramsey Skott
Tel: +1 914-409-2381
[email protected] Relations
Mark Hudson
Tel: +1 914-847-3482
[email protected]
2026-10-01 14:39 23d ago
2026-10-01 10:05 23d ago
Sanofi, Regeneron Expand DUPIXENT Alliance in Deal Worth Up to €8 Billion
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Giants Costco, Sanofi, and SAP Raise Dividends by Over 10%Regeneron and Sanofi NASDAQ: SNY announced an expanded collaboration focused on developing next-generation medicines for type 2 inflammatory diseases, extending an alliance that has produced the blockbuster therapy DUPIXENT.

Under the agreement, Regeneron will contribute four long-acting, fully human antibody programs targeting the IL-4 and IL-13 pathways. Sanofi will make a EUR 1 billion upfront payment to Regeneron and could pay up to EUR 7 billion more upon development, regulatory and commercial milestones. The companies will split development costs and global profits equally for the new alliance medicines.

Get Sanofi alerts:

Analysts Can't Get Enough of These Little-Known Biopharma StocksThe prior agreement governing DUPIXENT, including its profit-sharing arrangement, remains unchanged. Sanofi will continue to record net sales under the companies’ existing reporting practice, according to François-Xavier Roger, Sanofi’s executive vice president and chief financial officer.

Next-generation antibody portfolio The lead asset added to the alliance is a long-acting IL-13 antibody currently in clinical testing for atopic dermatitis. Regeneron said the program has shown long-lived pharmacokinetic properties and is targeting a dosing interval of at least every three to six months. Registrational studies are planned to begin in late 2027 or early 2028.

Analysts Think These Stocks Could More Than Double in ValueThe other three Regeneron programs are preclinical and are expected to be clinic-ready next year:

A long-acting IL-4/IL-13 bispecific antibody designed to block both cytokines; A long-acting antibody targeting the IL-4 receptor alpha, the same target addressed by DUPIXENT; and An antibody targeting IL-4. George Yancopoulos, Regeneron’s co-founder, board co-chair, president and chief scientific officer, said the companies intend to use the portfolio to select different approaches for different diseases, depending on whether blocking IL-13 alone or both IL-4 and IL-13 is considered appropriate.

Sanofi is also providing Regeneron an option to add lunsekimig, Sanofi’s IL-13/TSLP Nanobody, to the alliance. The option is contingent on data from a Phase II chronic obstructive pulmonary disease study. Sanofi’s Paulo Fontoura, executive vice president and head of research and development, said the company intends to use the COPD data to determine future plans for the asset.

Built on DUPIXENT commercial platform Leonard Schleifer, Regeneron’s co-founder, board co-chair, president and chief executive officer, said the companies plan to use their established global development and commercial infrastructure to support potential launches of the new medicines. The platform currently serves more than 1.5 million DUPIXENT patients globally, he said.

DUPIXENT recorded EUR 5.2 billion in global net sales in the second quarter of 2026, as reported by Sanofi, and was annualizing at more than EUR 20 billion across nine indications, Schleifer said. Yancopoulos said the therapy is FDA-approved across diseases involving the skin, gut and respiratory system, including use in patients from 6 months of age through older adults.

Belén Garijo, Sanofi’s chief executive officer, said only about 20% of eligible U.S. patients are currently treated with advanced therapies and that the market could nearly double over the next five years. She cited more than 2.5 million U.S. patients with moderate-to-severe atopic dermatitis and said Sanofi projects the U.S. market could reach approximately EUR 20 billion in sales by 2032.

Garijo said the expanded alliance assigns Regeneron final development decision-making authority, while Sanofi retains final commercial decision rights, including those related to pricing and market access. Regeneron will have increased participation in key payer discussions.

Agreement also resolves litigation Garijo said the transaction provides a stronger framework for the partnership, including clearer governance, greater transparency and the resolution of litigation between the companies.

During the question-and-answer session, Roger said DUPIXENT’s U.S. loss of exclusivity is currently expected in March 2031. He added that Sanofi is pursuing an extension of that period, though he said there is no certainty that an extension will be obtained.

Regeneron said the first EUR 1 billion milestone payment beyond the upfront consideration would be linked to the start of a Phase III program. Both companies said they aim to advance the new programs as quickly as possible, using their experience with clinical trial design, regulatory engagement and patient recruitment in type 2 inflammatory diseases.

About Sanofi (NASDAQ:SNY)Sanofi is a France-based global healthcare company that develops, manufactures and markets prescription medicines, vaccines and consumer healthcare products. Its portfolio focuses on areas including immunology, rare diseases, vaccines, diabetes and other chronic conditions, as well as specialized treatments for selected neurological and inflammatory disorders.

The company is known for products such as Dupixent, a biologic used to treat several inflammatory conditions, and a broad range of vaccines marketed through its Sanofi Pasteur business.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-10-01 07:20 23d ago
2026-10-01 01:00 23d ago
Press Release: Sanofi and Regeneron expand global Alliance with multiple next-generation, long-acting immunology antibodies
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Sanofi and Regeneron expand global Alliance with multiple next-generation, long-acting immunology antibodies

REGN20423, a clinical-stage long-acting IL-13 monoclonal antibody invented and developed by Regeneron, is added to the Alliance, along with a long-acting IL-4xIL-13 bispecific and two other long-acting pre-clinical antibodies from RegeneronRegeneron to receive $1 billion upfront, with potential for up to an additional $7 billion in future milestone payments; companies to equally share development and commercialization costs, as well as any future profitsSanofi and Regeneron to host a conference call for investors and analysts today at 14:00 CET/8:00am ET Paris and Tarrytown, NY, October 1, 2026. Sanofi and Regeneron Pharmaceuticals, Inc. today announce an expansion of their longstanding antibody collaboration, adding multiple next-generation, long-acting antibodies to the Alliance that has jointly established Dupixent® (dupilumab) as the world-leading treatment for diseases driven by type 2 inflammation. The agreement builds on the companies' more than 20-year collaboration, through which more than 1.5 million people are currently receiving Dupixent across nine indications, making it one of the most widely used antibody medicines in the world.

“This is a deliberate first step in igniting Sanofi’s innovation engine. Our longstanding Alliance with Regeneron has transformed the treatment landscape for millions of patients living with diseases driven by type 2 inflammation and created one of the world's leading immunology businesses,” said Belén Garijo, Chief Executive Officer of Sanofi. “By deepening our collaboration, we will make rapid progress in creating the next generation of meaningful therapies for patients with immune-mediated diseases, while contributing to Sanofi’s long-term future.”

Under the expanded license and collaboration agreement, the companies will co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies targeting interleukin-13 (IL-13), IL-4xIL-13 bispecific, interleukin-4 (IL-4) and interleukin-4 receptor alpha (IL-4Rα). IL-13 antibody REGN20423 is currently in a phase 1 clinical study for atopic dermatitis, and the other three antibodies are expected to enter clinical studies in 2027. Regeneron will also have the option to include in the collaboration Sanofi’s lunsekimig, an investigational bispecific Nanobody® VHH therapy targeting TSLP and IL-13, exercisable upon completion of its phase 3 studies for chronic obstructive pulmonary disease.

“The Regeneron-Sanofi Alliance has been one of the most productive in biopharma history. This agreement builds on that foundation to bring the next generation of immunology medicines to patients even faster,” said Leonard S. Schleifer, MD, PhD, Board co-Chair, President and Chief Executive Officer of Regeneron. “By expanding our Alliance, we are positioning promising new long-acting antibodies for the kind of rapid, global impact that our shared work on Dupixent has already achieved.”

Under the terms of the agreement, Regeneron will receive an upfront payment of $1 billion from Sanofi, with the potential for development, regulatory and commercial milestone payments of up to an additional $7 billion. The companies will share development and commercialization costs for the new programs and will split future profits from these potential products 50:50 on a global basis. Regeneron will lead research and development activities, and Sanofi will lead global commercial efforts. The existing profit-sharing agreement regarding Dupixent will not change.

“The companies’ clinical and commercial Alliance dates to 2003 and has resulted in multiple approved medicines to date, including Dupixent, which has redefined the standard of care for people with type 2 inflammatory diseases and is now one of the most widely used antibodies for any disease, with over 1.5 million active patients worldwide,” said George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “By combining Regeneron’s world-class scientific discovery and antibody development expertise with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology.”

The companies have settled their prior collaboration-related litigation.

Conference call for investors and analysts
Sanofi and Regeneron will host a conference call for investors and analysts today at 14:00 CET/8:00am ET. A presentation will be available for download from the Investor Relations section of sanofi.com and regeneron.com when the conference call starts.

Participants may access the conference call via webcast on the ‘Upcoming Events’ page of Sanofi’s website at https://www.sanofi.com/en/investors/news-events/upcoming-events, tab ‘Presentations' and on the 'Investors and Media' page of Regeneron's website at https://investor.regeneron.com/events-and-presentations. To participate via telephone, please register in advance at this link.

About Dupixent
Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis in different age populations. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit

www.Regeneron.com or follow Regeneron on

LinkedIn,

Instagram,

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About Sanofi 
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Sanofi Media Relations

Sandrine Guendoul | +33 6 25 09 14 25 | [email protected] 
Evan Berland | +1 215 432 0234 | [email protected]
Léo Le Bourhis | +33 6 75 06 43 81 | [email protected]
Victor Rouault | +1 617 356 4751 | [email protected]
Timothy Gilbert | +1 516 521 2929 | [email protected]
Léa Ubaldi | +33 6 30 19 66 46 | [email protected]
Laura Romby | +33 6 74 16 74 29 | [email protected]
Ekaterina Pesheva | +1 410 926 6780 | [email protected]

Sanofi Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | [email protected]
Alizé Kaisserian | +33 6 47 04 12 11 | [email protected]
Keita Browne | +1 781 249 1766 | [email protected]
Nathalie Pham | +33 7 85 93 30 17 | [email protected]
Nina Goworek | +1 908 569 7086 | [email protected]

Thibaud Châtelet | +33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]

Regeneron Media Relations
Christina Chan | +1 914-383-6374 | [email protected] 
Alexandra Bowie | +1 914-346-0588 | [email protected] 

Regeneron Investor Relations
Ryan Crowe | +1 914-847-8790 | [email protected]
Mark Hudson | +1 914-847-3482 | [email protected]

Sanofi forward-looking statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these, and similar expressions are intended to identify forward-looking statements.
Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation; trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markest Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein.

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.

Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation the research and clinical programs discussed or referenced in this press release such as those evaluating Regeneron-discovered antibodies targeting interleukin-13 (IL-13), interleukin-4 (IL-4), and interleukin-4 receptor alpha (IL-4Rα) as well as a bispecific antibody targeting IL-4xIL-13; the potential for any license, collaboration, or supply agreement, including Regeneron’s amended license and collaboration agreement with Sanofi discussed in this press release, to be cancelled or terminated without realizing the expected benefits of such agreement; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including based on the amended license and collaboration agreement discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as those referenced above; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Press_Release
2026-10-01 07:20 23d ago
2026-10-01 01:00 23d ago
Regeneron and Sanofi Expand Global Alliance with Multiple Next-Generation, Long-Acting Immunology Antibodies
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
REGN20423, a clinical-stage long-acting IL-13 monoclonal antibody invented and developed by Regeneron, is added to the alliance, along with a long-acting IL-4xIL-13 bispecific and two other long-acting preclinical antibodies from Regeneron

Regeneron to receive $1 billion upfront with potential for up to an additional $7 billion in future milestone payments; companies to equally share development and commercialization costs, as well as any future profits

Regeneron and Sanofi to host a conference call for investors and analysts today at 8:00 am ET/2:00 pm CET

TARRYTOWN, N.Y. and PARIS, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced an expansion of their long-standing antibody collaboration, adding multiple next-generation, long-acting antibodies to the alliance that has jointly established Dupixent® (dupilumab) as the world-leading treatment for diseases driven by type 2 inflammation. The agreement builds on the companies’ more than 20-year collaboration, through which more than 1.5 million people are currently receiving Dupixent across nine indications, making it one of the most widely used antibody medicines in the world.

“The Regeneron-Sanofi alliance has been one of the most productive in biopharma history. This agreement builds on that foundation to bring the next generation of immunology medicines to patients even faster,” said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. “By expanding our alliance, we are positioning promising new long-acting antibodies for the kind of rapid, global impact that our shared work on Dupixent has already achieved.”

Under the expanded license and collaboration agreement, the companies will co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies targeting interleukin-13 (IL-13), IL-4xIL-13 bispecific, interleukin-4 (IL-4) and interleukin-4 receptor alpha (IL-4Rα). IL-13 antibody REGN20423 is currently in a Phase 1 clinical trial for atopic dermatitis, and the other three antibodies are expected to enter clinical studies in 2027. Regeneron will also have the option to include in the collaboration Sanofi’s lunsekimig, an investigational bispecific Nanobody® VHH therapy targeting TSLP and IL-13, exercisable upon completion of its Phase 3 trials for chronic obstructive pulmonary disease.

“This is a deliberate first step in igniting Sanofi’s innovation engine. Our longstanding Alliance with Regeneron has transformed the treatment landscape for millions of patients living with diseases driven by type 2 inflammation and created one of the world's leading immunology businesses,” said Belén Garijo, Chief Executive Officer of Sanofi. “By deepening our collaboration, we will make rapid progress in creating the next generation of meaningful therapies for patients with immune-mediated diseases, while contributing to Sanofi’s long-term future.”

Under the terms of the agreement, Regeneron will receive an upfront payment of $1 billion from Sanofi, with the potential for development, regulatory and commercial milestone payments of up to an additional $7 billion. The companies will share development and commercialization costs for the new programs and will split future profits from these potential products 50:50 on a global basis. Regeneron will lead research and development activities, and Sanofi will lead global commercial efforts. The existing profit-sharing agreement regarding Dupixent will not change.

“The companies’ clinical and commercial alliance dates to 2003 and has resulted in multiple approved medicines to date, including Dupixent which has redefined the standard of care for people with type 2 inflammatory diseases and is now one of the most widely used antibodies for any disease, with over 1.5 million active patients worldwide,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “By combining Regeneron’s world-class scientific discovery and antibody development expertise with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology.”

The companies have settled their prior collaboration-related litigation.

Conference call for investors and analysts
Regeneron and Sanofi will host a conference call for investors and analysts today at 8:00 am ET/2:00 pm CET. A presentation will be available for download from the Investor Relations section of regeneron.com and sanofi.com when the conference call starts.

Participants may access today's conference call live via webcast on the 'Investors and Media' page of Regeneron's website at https://investor.regeneron.com/events-and-presentations and on the ‘Upcoming Events’ page of Sanofi’s website at https://www.sanofi.com/en/investors/news-events/upcoming-events. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

About Dupixent
Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 studies, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis in different age populations. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

Select Dupixent Safety Information for US Patients
Dupixent is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients. Warnings and precautions include hypersensitivity reactions; conjunctivitis, keratitis, and blepharitis; eosinophilic conditions; acute asthma symptoms or chronic obstructive pulmonary disease or acute deteriorating disease; risk associated with abrupt reduction of corticosteroid dosage; psoriasis; arthralgia and psoriatic arthritis; parasitic (helminth) infections; and avoidance of live vaccines. The most common adverse reactions vary by indication and include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes viral infection, dry eye, eosinophilia, oropharyngeal pain, insomnia, toothache, gastritis, arthralgia, upper respiratory tract infections, nasopharyngitis, dizziness, myalgia, diarrhea, viral infection, headache, back pain, urinary tract infection, rhinitis, and blurred vision.

Please see full Dupixent Prescribing Information including Patient Information for complete safety information.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

Regeneron Media Relations
Christina Chan | +1 914-383-6374 | [email protected] 
Alexandra Bowie | +1 914-346-0588 | [email protected] 

Regeneron Investor Relations
Ryan Crowe | +1 914-847-8790 | [email protected]
Mark Hudson | +1 914-847-3482 | [email protected]

Sanofi Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | [email protected]
Evan Berland | +1 215 432 0234 | [email protected]
Léo Le Bourhis | +33 6 75 06 43 81 | [email protected]
Victor Rouault | +1 617 356 4751 | [email protected]
Timothy Gilbert | +1 516 521 2929 | [email protected]
Léa Ubaldi | +33 6 30 19 66 46 | [email protected]
Ekaterina Pesheva | +1 410 926 6780 | [email protected]

Sanofi Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | [email protected]
Alizé Kaisserian | +33 6 47 04 12 11 | [email protected]
Keita Browne | +1 781 249 1766 | [email protected]
Nathalie Pham | +33 7 85 93 30 17 | [email protected]
Nina Goworek | +1 908 569 7086 | [email protected]
Thibaud Châtelet | +33 6 80 80 89 90 | [email protected]
Yun Li | +33 6 84 00 90 72 | [email protected]

Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation the research and clinical programs discussed or referenced in this press release such as those evaluating Regeneron-discovered antibodies targeting interleukin-13 (IL-13), interleukin-4 (IL-4), and interleukin-4 receptor alpha (IL-4Rα) as well as a bispecific antibody targeting IL-4xIL-13; the potential for any license, collaboration, or supply agreement, including Regeneron’s amended license and collaboration agreement with Sanofi discussed in this press release, to be cancelled or terminated without realizing the expected benefits of such agreement; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including based on the amended license and collaboration agreement discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as those referenced above; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Sanofi forward-looking statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these, and similar expressions are intended to identify forward-looking statements.

Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation;  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markest Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein.

All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center.
2026-10-01 07:20 23d ago
2026-10-01 01:17 23d ago
Sanofi to pay Regeneron $1 billion upfront in expanded immunology deal
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Sanofi (SASY.PA) said on Thursday it would pay US partner Regeneron (REGN.O) $1 billion upfront and up to $7 billion in milestone payments ​to bring four new antibodies under the partnership ​behind their blockbuster eczema drug Dupixent, which sent ⁠the French drugmaker's shares 2% higher in early ​trading.

Like Dupixent, used by more than 1.5 million patients ​across nine indications, these experimental antibodies target immune signals that drive inflammation in conditions such as eczema, but they are designed ​to last longer in the body.

Sanofi called the ​deal a first step in rebuilding its pipeline before Dupixent loses patent ‌protection

"While ⁠the assets are early-stage, the expansion should be viewed positively, as it signals the new CEO's proactive focus on the most important yet addressable uncertainties investors face," ​Jefferies wrote

The ​companies have ⁠settled earlier litigation over the collaboration

Regeneron to lead research and development, Sanofi to lead ​global sales under the expanded partnership

They will ​split ⁠costs and profits of the expanded partnership equally; existing Dupixent profit-sharing terms unchanged

Regeneron also has the option to ⁠join Sanofi's ​experimental drug lunsekimig once its ​late-stage trials for chronic obstructive pulmonary disease are finished
2026-10-01 07:20 23d ago
2026-10-01 02:27 23d ago
Sanofi, Regeneron to Expand Alliance in Deal Valued at Up to $8 Billion
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
The companies will share development and commercialization costs as well as potential future profits from the new drugs, they said.
2026-09-30 23:59 23d ago
2026-09-30 18:04 24d ago
Regeneron drug halves muscle loss in combination with Novo's semaglutide in trial
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
An experimental weight-loss drug being developed by Regeneron (REGN.O) used in combination with Novo Nordisk's (NOVOb.CO) semaglutide reduced the loss of muscle mass by 50% compared with the loss seen with semaglutide alone ​in a study of patients with obesity, according to data being presented at a medical meeting.

With the explosive popularity ‌of GLP-1 weight-loss drugs such as Novo's semaglutide, sold as Wegovy for obesity, there has been growing concern about significant loss of muscle accompanying rapidly shed pounds.

The Regeneron drug, trevogrumab, belongs to a different class of medicines that inhibits the protein myostatin, which is linked to loss of muscle mass.

When researchers ​measured thigh muscle in patients with MRI scans, the addition of a 75-milligram dose of trevogrumab preserved over 70% of ​muscle mass loss compared with semaglutide alone at 52 weeks, a summary of the data showed.

"We ⁠confirmed that indeed patients that take GLP-1s lose about 30% of their weight in the form of lean muscle mass, that with ​trevogrumab we can prevent," said Regeneron executive Boaz Hirshberg, adding the greatest benefit could potentially be for patients who begin treatment with ​lower muscle mass.

Data from the trial of nearly 1,000 patients between the ages of 18 and 65 was being presented at the European Association for the Study of Diabetes conference in Milan on Thursday.

Wall Street and the medical community are looking for evidence that next-generation drugs like anti-myostatins can prevent the ​body from breaking down muscle during weight loss.

At least a dozen companies are working on muscle-preserving therapies, with analysts forecasting the medicines could reach $30 ​billion in annual sales by 2035.

The multi-pronged trial initially included a second experimental Regeneron antibody drug, garetosmab.

In the first 26 weeks, two participants who received higher ‌doses of ⁠trevogrumab in combination with garetosmab died. One death was due to an undetermined cause in a patient with multiple cardiovascular risk factors and the second was caused by cardiac arrest in a person with a history of cardiovascular disease, the company said.

Trevogrumab alone showed a safety profile similar to semaglutide, with no unexpected side effects, the company said.

The trevogrumab/garetosmab combination led to greater lean-mass preservation than trevogrumab ​alone but had a high ​rate of adverse side effects, ⁠including muscle spasms. Regeneron said it will not move forward with the triple combination.

The mid-stage study was performed as a two-part trial.

In one part of the trial, patients on semaglutide alone lost 6.7% of ​their lean muscle mass over 26 weeks. Those who also took 75 milligrams of trevogrumab lost ​only 3.3% of ⁠muscle mass. The combination with 25 mg of trevogrumab led to 4.7% loss of muscle mass.

When patients stopped semaglutide but kept taking trevogrumab, their muscle mass returned to where it started before the study, suggesting the drug could help rebuild the lost muscle, the company said.

Regeneron said ⁠it has ​selected the 75-mg once-weekly dose for further studies and plans another mid-stage trial ​in patients over 65.

"What we want to do is concentrate on the quality of weight reduction," Regeneron's Hirshberg said. "We want to find the best way to approach ​weight reduction, especially in vulnerable patients."
2026-09-30 09:19 24d ago
2026-09-30 02:46 24d ago
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Stock Has Average Target Price of $802.18
REGN Regeneron Pharmaceuticals
FMP Stock News
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Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Get Free Report) has earned a consensus rating of “Moderate Buy” from the twenty-four brokerages that are presently covering the stock, Marketbeat.com reports. Ten research analysts have rated the stock with a hold rating and fourteen have given a buy rating to the company. The average 1-year target price among analysts that have issued a report on the stock in the last year is $802.18.

Several research analysts have issued reports on the stock. Truist Financial increased their target price on shares of Regeneron Pharmaceuticals from $769.00 to $772.00 and gave the stock a “buy” rating in a report on Friday, July 31st. Guggenheim upped their price target on shares of Regeneron Pharmaceuticals from $1,000.00 to $1,030.00 and gave the stock a “buy” rating in a research report on Monday, August 3rd. Morgan Stanley increased their price objective on shares of Regeneron Pharmaceuticals from $730.00 to $758.00 and gave the company an “equal weight” rating in a research note on Friday, July 31st. Weiss Ratings reiterated a “hold (c)” rating on shares of Regeneron Pharmaceuticals in a research note on Monday, September 21st. Finally, Wells Fargo & Company lifted their price objective on shares of Regeneron Pharmaceuticals from $700.00 to $750.00 and gave the company an “equal weight” rating in a report on Friday, July 31st.

Read Our Latest Stock Analysis on Regeneron Pharmaceuticals

Insider Buying and Selling In related news, Director Arthur F. Ryan sold 200 shares of the company’s stock in a transaction on Thursday, July 2nd. The stock was sold at an average price of $650.15, for a total transaction of $130,030.00. Following the completion of the sale, the director directly owned 17,303 shares in the company, valued at $11,249,545.45. This represents a 1.14% decrease in their position. The sale was disclosed in a document filed with the SEC, which is available through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, EVP Marion Mccourt sold 1,215 shares of the firm’s stock in a transaction dated Wednesday, September 2nd. The shares were sold at an average price of $850.00, for a total value of $1,032,750.00. Following the sale, the executive vice president directly owned 13,134 shares in the company, valued at approximately $11,163,900. The trade was a 8.47% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last 90 days, insiders have sold 4,146 shares of company stock valued at $3,432,488. 6.97% of the stock is owned by insiders. Institutional Trading of Regeneron Pharmaceuticals Several hedge funds have recently modified their holdings of REGN. BlackRock Inc. purchased a new position in shares of Regeneron Pharmaceuticals in the 2nd quarter worth approximately $5,682,636,000. Nuveen LLC boosted its stake in Regeneron Pharmaceuticals by 71.1% in the fourth quarter. Nuveen LLC now owns 2,010,517 shares of the biopharmaceutical company’s stock valued at $1,551,858,000 after acquiring an additional 835,240 shares in the last quarter. Legal & General Group Plc acquired a new stake in Regeneron Pharmaceuticals in the second quarter valued at approximately $473,872,000. Bank of New York Mellon Corp purchased a new position in Regeneron Pharmaceuticals in the second quarter worth $472,950,000. Finally, Deutsche Bank AG acquired a new position in shares of Regeneron Pharmaceuticals during the second quarter worth $323,249,000. 83.31% of the stock is owned by hedge funds and other institutional investors.

More Regeneron Pharmaceuticals News Here are the key news stories impacting Regeneron Pharmaceuticals this week:

Positive Sentiment: Regeneron is collaborating with Biohaven on a clinical study combining Biohaven’s BHV-1530 with Regeneron’s cancer drug Libtayo in patients with solid tumors. Enrollment in the combination cohort is underway, creating a potential long-term pipeline opportunity. Why Did Regeneron Pharmaceuticals Stock Drop Today? Positive Sentiment: Regeneron’s upcoming third-quarter earnings report is an important potential catalyst. The company recently delivered earnings and revenue above consensus expectations, and its shares continue to screen as a value candidate relative to some biotechnology peers. Should You Buy Regeneron Pharmaceuticals Stock Before October 30? Neutral Sentiment: Royal Bank of Canada reaffirmed its “sector perform” rating and assigned a $737 price target, indicating limited near-term upside based on its current valuation assessment. Regeneron Rating Reaffirmed by Royal Bank of Canada Neutral Sentiment: Comparisons with Illumina and European drugmakers GSK and Sanofi highlight Regeneron’s valuation and earnings outlook, but these articles do not identify a new fundamental change specific to REGN. REGN or ILMN Value Comparison Negative Sentiment: Kodiak Sciences reported positive Phase 3 DAYBREAK results for Zenkuda and tabirafusp-ted, with both candidates meeting primary endpoints against Eylea in wet age-related macular degeneration. The potential for similar vision outcomes with approximately six-month dosing, compared with Eylea’s roughly eight-week schedule, raises a meaningful competitive threat to Eylea’s market share and future growth. Kodiak’s stock surged more than 170% on the news, intensifying pressure on REGN. Kodiak Positive Eye-Drug Study Data Regeneron Pharmaceuticals Price Performance Shares of REGN stock opened at $750.51 on Wednesday. Regeneron Pharmaceuticals has a twelve month low of $541.00 and a twelve month high of $859.34. The company has a current ratio of 3.34, a quick ratio of 2.78 and a debt-to-equity ratio of 0.06. The stock has a fifty day simple moving average of $782.91 and a two-hundred day simple moving average of $720.82. The stock has a market capitalization of $77.27 billion, a price-to-earnings ratio of 18.55, a P/E/G ratio of 1.47 and a beta of 0.20.

Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) last announced its quarterly earnings results on Thursday, July 30th. The biopharmaceutical company reported $14.29 EPS for the quarter, beating the consensus estimate of $10.16 by $4.13. Regeneron Pharmaceuticals had a return on equity of 13.47% and a net margin of 27.86%.The firm had revenue of $4.29 billion for the quarter, compared to analyst estimates of $3.82 billion. During the same quarter last year, the firm posted $12.81 earnings per share. The business’s revenue for the quarter was up 16.7% on a year-over-year basis. On average, analysts predict that Regeneron Pharmaceuticals will post 44.25 EPS for the current fiscal year.

Regeneron Pharmaceuticals Dividend Announcement The business also recently announced a quarterly dividend, which was paid on Monday, August 31st. Shareholders of record on Tuesday, August 18th were given a dividend of $0.94 per share. This represents a $3.76 annualized dividend and a yield of 0.5%. The ex-dividend date of this dividend was Tuesday, August 18th. Regeneron Pharmaceuticals’s dividend payout ratio (DPR) is 9.29%.

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Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses human genetics, antibody technology and other biological research platforms to develop treatments in areas including eye diseases, cancer, cardiovascular and metabolic disorders, inflammatory diseases, infectious diseases and rare conditions.

Regeneron’s marketed products include EYLEA and EYLEA HD for certain retinal diseases; Dupixent, developed and commercialized with Sanofi, for multiple allergic and inflammatory conditions; Libtayo for certain cancers; Praluent for high cholesterol; Kevzara for rheumatoid arthritis and other inflammatory diseases; Evkeeza for homozygous familial hypercholesterolemia; and Veopoz for a rare immune-mediated disorder.

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2026-09-28 18:05 26d ago
2026-09-28 13:05 26d ago
Should You Buy Regeneron Pharmaceuticals Stock Before Oct. 30?
REGN Regeneron Pharmaceuticals
FMP Stock News
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Regeneron Pharmaceuticals' (REGN -4.19%) stock is having an underwhelming year, down around 1% thus far. It's been a quality growth stock to own for the long haul, and with some terrific assets in its portfolio, it has the potential to perform much better in the long run.

Next month, on Oct. 30, it will release its third-quarter earnings results. A solid round of results could be just what's needed for the healthcare stock to rally. Is it a good buy before then?

Image source: Getty Images.

The company's most recent results gave the stock a boostWhen Regeneron last reported earnings in late July, the numbers were strong, and gave the stock a boost in the days and weeks afterward. The company's revenue for the quarter, which went up until the end of June, totaled $4.3 billion and rose 17% year over year. Global sales of Dupixent and Libtayo were particularly strong, rising by 38% and 30%, respectively. Revenue for Eylea HD in the U.S. was also up an impressive 52%.

As a result of the strong numbers, the stock would end up rising afterward, eventually hitting a new 52-week high in early September. It's come down from those highs since, but if there's another strong quarter of growth, Regeneron's stock may rally once again, especially if its growth rate, which hasn't been all that strong in recent years, remains in double-digits yet again.

REGN Revenue (Quarterly YoY Growth) data by YCharts

Regeneron may be a slam-dunk buy right nowAlthough it hasn't been a great year for Regeneron, this is a healthcare stock that could have plenty of room to rise much higher given its solid results, modest valuation, and tremendous growth prospects.

Not only is the business growing at a decent pace of late, but it also has a strong pipeline of drugs, with around 50 product candidates in development, which could pave the way for much more growth in the future.

Meanwhile, with the stock trading at only 19 times trailing earnings and falling to a multiple of less than 15 based on future profits (based on analyst expectations), it makes for a solid value buy. By comparison, the average stock on the S&P 500 trades at more than 23 times its trailing profits and roughly 20 times forward earnings.

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Regeneron's stock may be overdue for a bigger rally. Its last earnings report gave the stock a bit of a boost, and the same might happen again after it releases its latest numbers in late October. But whether that happens or not, for long-term investors, now can be a terrific time to load up on this top growth stock.
2026-09-28 15:38 26d ago
2026-09-28 09:03 26d ago
Why Regeneron Rival Kodiak Sciences Just Skyrocketed 90%-Plus
REGN Regeneron Pharmaceuticals
FMP Stock News
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Kodiak Sciences stock skyrocketed Monday on a double win for its potential rivals to Regeneron Pharmaceuticals' blockbuster eye drug, Eylea.
2026-09-28 15:38 26d ago
2026-09-28 10:05 26d ago
Kodiak Sciences Says Eye Drug on Par with Regeneron's Medicine
REGN Regeneron Pharmaceuticals
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Kodiak Sciences Inc. (NASDAQ:KOD) on Monday released data from the Phase 3 DAYBREAK trial for patients suffering from wet age-related macular degeneration (wAMD).

The study showed that both Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) achieved their primary endpoints.

DAYBREAK Trial ResultsThe study demonstrated that Zenkuda and tabirafusp-ted provided non-inferior vision gains compared to Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) Eylea (aflibercept) after one year.

Zenkuda showed a strong, immediate clinical effect during the initial treatment phase, comparable to or exceeding aflibercept.

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It also exhibited lasting results, with 54% of patients maintaining vision improvements for six months at the one-year mark.

Safety and Future PlansBoth Zenkuda and tabirafusp-ted were well-tolerated and demonstrated favorable safety profiles.

Zenkuda reported a 0% rate of intraocular inflammation and a 0.5% rate of cataract adverse events, lower than the 0.9% seen with aflibercept.

Tabirafusp-ted showed a 0.4% intraocular inflammation rate and no cataract adverse events.

Kodiak Sciences intends to submit a multi-indication biologics license application (BLA) for Zenkuda to regulatory agencies in the fourth quarter of 2026.

This submission will include data from five Phase 3 studies: DAYBREAK and DAYLIGHT for wAMD, GLOW and GLOW2 for diabetic retinopathy, and BEACON for macular edema associated with retinal vein occlusion.

The company will also conduct further analyses to determine which previously untreated wAMD patients might benefit most from IL-6 inhibition.

Development of tabirafusp-ted is accelerating for diabetic macular edema, with active enrollment underway for the ALTO Phase 3 study.

KOD Price Action: Kodiak Sciences shares were up 137.09% at $76.70 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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2026-09-28 15:38 26d ago
2026-09-28 11:17 26d ago
Regeneron Eylea Feels the Pinch as Kodiak Advances Extended Dosing for Eye Drug
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) stock is trading lower on Monday, probably in reaction to positive data from Kodiak Sciences Inc.’s (NASDAQ:KOD) data from the Phase 3 DAYBREAK trial for wet age-related macular degeneration (wAMD).

The study demonstrated that Zenkuda and tabirafusp-ted provided non-inferior vision gains compared to Regeneron’s Eylea (aflibercept) after one year.

Zenkuda showed a strong, immediate clinical effect during the initial treatment phase, comparable to or exceeding aflibercept.

FDA Regulatory Context And Eylea HD ApprovalsIn November 2025, the U.S. Food and Drug Administration (FDA) approved Eylea HD (aflibercept) Injection 8 mg for patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.

The FDA also approved a monthly dosing option for some patients who may benefit from resuming this dosing schedule across approved indications: wAMD, diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.

Kodiak Focuses On Six-Month Dosing BenchmarkInvestors should note that Kodiak Sciences is assessing a six-month dosing schedule.

Kodiak noted that the six-month dosing establishes a first-line benchmark in wAMD.

“Twenty years after Lucentis (ranibizumab) was approved for wet AMD, the holy grail remains the same: robust anatomic disease control and maximal visual gains, sustained with less frequent dosing,” said David Brown, Chief Medical Officer, Retina Consultants of America.

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“The DAYBREAK results with Zenkuda are truly impressive. Under an AI-guided retreatment algorithm that closely mirrors the zero-fluid-tolerance approach we use in clinic, more than half of patients were maintained on 24-week dosing through year one,” Brown further commented.

Latest Financial Performance of EyleaNet product sales of Eylea HD increased 52% to $596 million in the second quarter of 2026, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.

Net product sales of Eylea fell 45% to $412 million, negatively impacted by lower sales volumes driven by decreased demand as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and a lower net selling price.

REGN Price Action: Regeneron Pharmaceuticals shares were down 3.45% to $760.83 at the time of publication on Monday, according to Benzinga Pro data.

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© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
2026-09-25 16:44 29d ago
2026-09-25 11:31 29d ago
Sanofi's New Drugs Poised to Drive Growth Beyond Dupixent
REGN Regeneron Pharmaceuticals
FMP Stock News
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Key Takeaways Sanofi's new and acquired drugs saw sales jump 48.3% to 1.3 billion in Q2.Altuviiio, Ayvakit and Sarclisa led growth, with Ayvakit expected to become a blockbuster in 2026.Sanofi expects newer launches to generate about 10 billion in annual sales by 2030. Sanofi’s (SNY - Free Report) most important medicine remains its immunology drug, Dupixent, which continues to be the company’s primary growth engine. Dupixent sales represented roughly 42% of Sanofi’s first-half 2026 revenues.

Sanofimarkets Dupixent in partnership with Regeneron (REGN - Free Report) . While sales are recorded by Sanofi, Regeneron records its share of profits/losses in connection with global sales of Dupixent.

At the same time, Sanofi is seeing a good uptake of its new medicines like novel recombinant factor VIII therapy, Altuviiio, and cancer drugs, Ayvakit and Sarclisa, which are important for broadening the company’s growth base.

Sales of its new and acquired drugs rose 48.3% at constant exchange rates to €1.3 billion in the second quarter, led by Altuviiio, Ayvakit and Sarclisa. Altuviiio achieved blockbuster sales in 2025. Ayvakit, added from the Blueprint Medicines acquisition, is expected to become the next blockbuster drug in 2026. Beyfortus (in partnership with AstraZeneca [AZN]) achieved blockbuster sales in its first full year of sales in 2024 and continues its expansion into new geographies.

Some other new products approved in the past couple of years include Wayrilz (rilzabrutinib), for immune thrombocytopenia, and Qfitlia (fitusiran), to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A and B. Cenrifki (tolebrutinib) was approved for treating non-relapsing secondary progressive multiple sclerosis in the EU in June 2026, while in the United States, Sanofi’s regulatory application seeking approval of tolebrutinib was issued a complete response letter in December 2025. Sanofi’s new drug application seeking approval for venglustat for Gaucher Disease is under FDA’s priority review, with a decision expected in November. Venglustat is also under regulatory review in the EU.

The newer medicines should become an increasingly important contributor to Sanofi’s revenue growth in the coming quarters, even as Dupixent remains the largest driver. Sanofi now expects its Pharma launches to generate approximately €10 billion of annual sales by 2030, compared with about €25 billion for Dupixent. This suggests the company is positioning Altuviiio, Ayvakit, Sarclisa and other newer medicines to gradually broaden its revenue base and reduce reliance on Dupixent over the longer term.

SNY’s Price, Valuation & Estimate MovementSanofi stock has plunged 15.5% year to date against an appreciation of 11.7% for the industry.

Image Source: Zacks Investment Research

From a valuation standpoint, Sanofi appears attractive relative to the industry. Going by the price/earnings ratio, the company’s shares currently trade at 7.82 forward earnings, lower than 18.08 for the industry. The stock is also trading below the stock’s 5-year mean of 11.11. The stock is much cheaper than most large drugmakers like Eli Lilly (LLY - Free Report) , Novo Nordisk, AstraZeneca (AZN - Free Report) , J&J, Merck, AbbVie and others.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 earnings has risen from $4.96 per share to $5.07 per share over the past 60 days.For 2027, earnings estimates have risen from $5.18 per share to $5.29 per share over the same timeframe.

Image Source: Zacks Investment Research

Sanofi has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
2026-09-24 21:12 29d ago
2026-09-24 16:05 1mo ago
Regeneron to Report Third Quarter 2026 Financial and Operating Results and Host Conference Call and Webcast on October 30, 2026
REGN Regeneron Pharmaceuticals
FMP Stock News
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 | Source: Regeneron Pharmaceuticals, Inc.

TARRYTOWN, N.Y., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2026 financial and operating results on Friday, October 30, 2026, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

Conference Call Information
Participants may access the conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at https://investor.regeneron.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay and transcript of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. 

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
2026-09-23 20:44 1mo ago
2026-09-23 14:29 1mo ago
Regeneron Pharmaceuticals, Inc. (REGN) Presents at Bernstein Insights: Healthcare Leaders and Disruptors - 3rd Annual Healthcare Forum Transcript
REGN Regeneron Pharmaceuticals
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Regeneron Pharmaceuticals, Inc. (REGN) Presents at Bernstein Insights: Healthcare Leaders and Disruptors - 3rd Annual Healthcare Forum Transcript
2026-09-23 18:18 1mo ago
2026-09-23 12:04 1mo ago
Regeneron Highlights EYLEA HD Momentum, Dupixent Growth and Pipeline Catalysts
REGN Regeneron Pharmaceuticals
FMP Stock News
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Amylyx Stock: Why the Full Pipeline Story MattersRegeneron Pharmaceuticals NASDAQ: REGN executives highlighted continued growth across key marketed products, a broad late-stage pipeline and an ongoing focus on science-driven business development during a discussion with Bernstein analyst Jeffrey Walch.

Chris Fenimore, Regeneron’s executive vice president of finance and chief financial officer, said the company delivered double-digit year-over-year growth in both revenue and earnings during the most recent quarter. He said EYLEA HD, Dupixent and Libtayo each reached all-time quarterly net sales.

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Ozempic, Mounjaro, Wegovy, or Zepbound? This ETF Holds Them AllFenimore also said Regeneron paid off its Sanofi development balance during the second quarter. That balance had historically affected Regeneron’s share of profits from its collaboration with Sanofi, and its repayment is expected to lift earnings from the collaboration beginning in the third quarter.

EYLEA HD Gains Momentum Fenimore said EYLEA HD represented roughly 60% of EYLEA franchise net sales in the second quarter. He attributed the product’s performance in part to label enhancements approved in the fourth quarter of 2025, including every-four-week dosing flexibility and an additional retinal vein occlusion indication.

Pfizer Adds to Its Big Bet on Weight Loss DrugsAccording to Fenimore, the dosing flexibility provided physicians with reimbursement confidence if patients needed more frequent treatment. He added that EYLEA HD was the only innovative brand in its category to gain market share during the second quarter.

Regeneron expects sequential demand growth for EYLEA in the low- to mid-teens percentage range in both the third and fourth quarters, Fenimore said. The company faces additional biosimilar competition in the 2-milligram market, but executives said they remain constructive on EYLEA HD’s ability to grow as physicians gain more real-world experience with the therapy.

Fenimore said physicians switching patients from other products to EYLEA HD have seen treatment intervals extend by close to four weeks on average.

Dupixent and Libtayo Growth Fenimore described Dupixent, which Regeneron markets in collaboration with Sanofi, as annualizing at roughly $24 billion in sales, including approximately $18 billion in the U.S. He said the product is approved in nine U.S. indications, four of which have achieved blockbuster status.

More than 40% of Dupixent total prescriptions and roughly half of new-brand prescriptions are now outside atopic dermatitis, according to Fenimore. He added that Dupixent is the most prescribed biologic among dermatologists, pulmonologists, allergists and ear, nose and throat specialists.

Ryan Crowe, Regeneron’s senior vice president of investor relations, said the companies hold a U.S. composition-of-matter patent for dupilumab that expires in March 2031. He said the patent expires in Europe in 2033 and Japan in 2034, while additional method-of-treatment, manufacturing and formulation patents extend into the early to mid-2040s.

Regeneron and Sanofi are also in active discussions about expanding their collaboration beyond Dupixent, Fenimore said, though he did not provide details.

For Libtayo, Crowe said sales rose more than 30% year over year in the most recent quarter. In the U.S., about 60% of sales came from cutaneous squamous cell carcinoma and basal cell carcinoma, while non-small cell lung cancer accounted for about 40%.

Crowe said Libtayo is now second in both new-to-brand and total share in U.S. lung cancer, with new-to-brand share exceeding that of Opdivo, Imfinzi and Tecentriq combined. He said Regeneron is preparing for eventual biosimilar competition to Keytruda but believes Libtayo has differentiation in squamous cell lung cancer.

Pipeline Readouts Ahead Executives outlined several anticipated pipeline events, particularly in Regeneron’s C5 franchise. Crowe said the FDA action date for cemdisiran in generalized myasthenia gravis is in November. Regeneron believes the therapy could offer differentiated efficacy, safety and dosing that would require four administrations annually.

The company also expects registration-enabling data in paroxysmal nocturnal hemoglobinuria, or PNH, during the fourth quarter. The study is evaluating cemdisiran in combination with pozelimab against eculizumab. Crowe said disease control, as measured by lactate dehydrogenase, appears supported by earlier data, though transfusion avoidance could present risk because not all transfusions are caused by intravascular hemolysis.

In geographic atrophy, Regeneron plans an interim assessment of systemic cemdisiran alone and in combination with pozelimab. The company will evaluate whether the treatments slow the progression of geographic lesion size compared with placebo. Crowe cautioned that systemic approaches in geographic atrophy have historically been challenging and noted potential infection risks associated with extensive complement inhibition in an elderly population.

Regeneron expects to share data later this year from siRNA programs targeting MASH-related liver disease. Initial Phase III data from Factor XI studies in venous thromboembolism prevention are expected next year. Short-duration Phase II data for its Factor XI program in atrial fibrillation are expected around the middle of next year. Data from an adjuvant melanoma study of fianlimab plus Libtayo are expected late this year or in early 2027. Science, Business Development and Capital Allocation Fenimore said Regeneron’s development strategy is rooted in its genetics, immunology and antibody-engineering capabilities. The Regeneron Genetics Center has sequenced more than 3 million exomes linked to electronic health records and is expanding into proteomics, he said.

Crowe said Regeneron expects to bring four novel targets discovered or validated by the genetics center into the clinic this year, spanning immunology, ophthalmology and oncology.

On business development, Fenimore said the company evaluates acquisitions and collaborations based primarily on scientific merit, including whether an opportunity adds technology, platforms or assets that complement internal work. He said Regeneron has walked away from opportunities because of underlying data concerns or valuations that did not support the company’s expected risk-adjusted returns.

The company’s capital-allocation priorities include funding its pipeline, pursuing external opportunities, paying dividends and repurchasing shares. Fenimore said Regeneron began a dividend program in 2025 that pays roughly $400 million annually. Crowe said the company repurchased approximately $2 billion of stock in the first half, including $1.2 billion during the second quarter.

About Regeneron Pharmaceuticals (NASDAQ:REGN)Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses technologies involving genetics, antibodies and other biologic treatments to advance therapies in areas such as eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease and rare disorders.

Regeneron's marketed medicines include EYLEA and EYLEA HD for retinal diseases, Libtayo for certain cancers, Praluent for cardiovascular disease, Evkeeza for homozygous familial hypercholesterolemia and Veopoz for a rare immune disorder.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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2026-09-22 20:13 1mo ago
2026-09-22 15:15 1mo ago
Is Regeneron Stock a Bargain Below $800?
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals' (REGN +1.07%) shares climbed well above $1,000 two years ago, reaching all-time highs. However, they have dropped significantly from those levels over the past 24 months and now sit slightly below $800 apiece. What has happened to Regeneron? Is the stock a great buy at current levels? Let's find out.

Recent financial results In the second quarter, Regeneron's revenue increased by 17% year over year to $4.3 billion. That was a strong performance for the biotech, largely driven by its biggest growth driver, Dupixent, a medicine it co-markets with Sanofi (SNY +0.13%). Dupixent's global net sales (recorded by Sanofi) jumped 38% year over year to $6 billion.

Image source: The Motley Fool.

Dupixent is one of the leading medicines in the eczema market, but newer indications, including in COPD, are contributing as well. Dupixent should remain Regeneron's most important growth driver until the early 2030s, when it could potentially lose patent exclusivity. However, Regeneron and Sanofi have a plan to defend their empire, notably by developing a newer, higher-dose (HD) formulation of Dupixent that could earn approval in some of Dupixent's existing indications and retain many of its patients.

Can this strategy work? It's worth noting that Regeneron took the same approach with its other growth driver, Eylea, which treats several eye-related disorders. Eylea started facing biosimilar competition in late 2024. Even before that, it faced a more competitive landscape, especially since Roche's (OTC: RHHBY) Vabysmo was approved in January 2022. But the launch of HD Eylea, which earned approval in 2023, is helping mitigate the losses from the original version.

In the second quarter, combined U.S. sales of Eylea and Eylea HD were about $1 billion, down 12% year over year. U.S. revenue from Eylea HD came in at $596 million, up 52% year over year, while sales of the original version in the country declined 45% year over year. Eylea HD will likely continue to gain traction, thanks to its friendlier dosing schedule. And as the impact of declining Eylea sales on Regeneron's financial results weakens, the company could maintain robust top-line growth.

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New products could contribute, too Eventually, Regeneron will have to develop new blockbuster products. The company has several interesting candidates, including an investigational weight loss medicine called olatorepatide. This therapy mimics the actions of the gut hormones GLP-1 and GIP, just like the current market leader, Zepbound. That doesn't guarantee approval, not by a long shot, but there is another important fact to know: Regeneron licensed olatorepatide from a China-based biotech, and the anti-obesity treatment has already posted strong phase 3 study results in China. In a late-stage trial enrolling 604 patients, the medicine led to a weight loss of up to 19% over 48 weeks. Zepbound recorded an average weight loss of 20.2% in one 72-week clinical trial.

Does that mean olatorepatide is the superior medicine? Not necessarily. There are several caveats to keep in mind, including the difficulty of comparing across clinical trials and the fact that the olatorepatide study was in China. Still, the medicine looks highly promising and could become a notable player in the already large and fast-growing weight-loss market. Of note, Regeneron is also developing a medicine that could be administered alongside GLP-1s to help patients maintain muscle mass as they lose weight.

And beyond this promising therapeutic area, Regeneron is working on products in other fields, including oncology, immunology, and more.

The company could have a much stronger lineup of approved drugs by the end of the decade.

Regeneron's shares have lagged broader equities over the past two years, largely due to its Eylea-related problems. But the company's financial results have improved significantly in recent quarters; Eylea HD continues to gain steam; it has a long-term plan to keep its Dupixent empire mostly intact; and it is developing several promising pipeline candidates, such as olatorepatide. Even with the very real possibility of clinical and regulatory setbacks, my view is that Regeneron's shares look very attractive at current levels -- with its shares trading below $800 apiece -- especially once we factor in its dividend and share buyback programs.
2026-09-18 08:22 1mo ago
2026-09-18 03:15 1mo ago
Corient Private Wealth LP Sells 5,600 Shares of Regeneron Pharmaceuticals, Inc. $REGN
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Corient Private Wealth LP lowered its stake in shares of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Free Report) by 31.0% during the 2nd quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The firm owned 12,473 shares of the biopharmaceutical company’s stock after selling 5,600 shares during the period. Corient Private Wealth LP’s holdings in Regeneron Pharmaceuticals were worth $7,779,000 as of its most recent filing with the Securities and Exchange Commission.

Several other large investors also recently made changes to their positions in REGN. SHP Wealth Management bought a new stake in Regeneron Pharmaceuticals during the 4th quarter valued at $26,000. Western Wealth Management LLC bought a new position in Regeneron Pharmaceuticals in the 1st quarter valued at about $26,000. Titan Wealth CI Ltd acquired a new position in Regeneron Pharmaceuticals during the 4th quarter valued at about $29,000. Mowery & Schoenfeld Wealth Management LLC bought a new stake in Regeneron Pharmaceuticals during the 2nd quarter worth approximately $29,000. Finally, Trust Co. of Vermont purchased a new stake in shares of Regeneron Pharmaceuticals in the second quarter worth approximately $29,000. 83.31% of the stock is currently owned by institutional investors and hedge funds.

Regeneron Pharmaceuticals Stock Performance Shares of REGN opened at $789.45 on Friday. The stock’s fifty day moving average price is $764.43 and its two-hundred day moving average price is $720.28. Regeneron Pharmaceuticals, Inc. has a 1 year low of $541.00 and a 1 year high of $859.34. The firm has a market cap of $81.28 billion, a PE ratio of 19.51, a PEG ratio of 1.52 and a beta of 0.20. The company has a debt-to-equity ratio of 0.06, a current ratio of 3.34 and a quick ratio of 2.78.

Regeneron Pharmaceuticals (NASDAQ:REGN – Get Free Report) last released its quarterly earnings data on Thursday, July 30th. The biopharmaceutical company reported $14.29 EPS for the quarter, beating the consensus estimate of $10.16 by $4.13. The business had revenue of $4.29 billion for the quarter, compared to the consensus estimate of $3.82 billion. Regeneron Pharmaceuticals had a net margin of 27.86% and a return on equity of 13.47%. The company’s revenue was up 16.7% compared to the same quarter last year. During the same period in the prior year, the firm earned $12.81 earnings per share. On average, equities research analysts forecast that Regeneron Pharmaceuticals, Inc. will post 44.25 EPS for the current year. Regeneron Pharmaceuticals Announces Dividend The firm also recently declared a quarterly dividend, which was paid on Monday, August 31st. Stockholders of record on Tuesday, August 18th were given a $0.94 dividend. The ex-dividend date of this dividend was Tuesday, August 18th. This represents a $3.76 annualized dividend and a dividend yield of 0.5%. Regeneron Pharmaceuticals’s payout ratio is 9.29%.

Insider Buying and Selling at Regeneron Pharmaceuticals In related news, Director Arthur Ryan sold 200 shares of the company’s stock in a transaction that occurred on Thursday, July 2nd. The shares were sold at an average price of $650.15, for a total transaction of $130,030.00. Following the sale, the director directly owned 17,303 shares in the company, valued at approximately $11,249,545.45. This represents a 1.14% decrease in their position. The sale was disclosed in a filing with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Kathryn Guarini sold 400 shares of the firm’s stock in a transaction that occurred on Wednesday, September 2nd. The stock was sold at an average price of $850.00, for a total transaction of $340,000.00. Following the completion of the transaction, the director directly owned 603 shares of the company’s stock, valued at approximately $512,550. This trade represents a 39.88% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last 90 days, insiders have sold 4,146 shares of company stock valued at $3,432,488. 6.97% of the stock is owned by corporate insiders.

Analysts Set New Price Targets Several equities research analysts recently issued reports on REGN shares. Citigroup upped their price target on Regeneron Pharmaceuticals from $700.00 to $740.00 and gave the stock a “neutral” rating in a report on Monday, August 3rd. Sanford C. Bernstein upgraded shares of Regeneron Pharmaceuticals to a “hold” rating in a research note on Wednesday, July 29th. Leerink Partners raised their price target on shares of Regeneron Pharmaceuticals from $641.00 to $824.00 and gave the company a “market perform” rating in a research report on Monday, August 17th. Wall Street Zen cut shares of Regeneron Pharmaceuticals from a “strong-buy” rating to a “buy” rating in a report on Saturday, September 12th. Finally, Weiss Ratings reiterated a “hold (c)” rating on shares of Regeneron Pharmaceuticals in a report on Wednesday, June 24th. Fourteen research analysts have rated the stock with a Buy rating and ten have issued a Hold rating to the company. According to data from MarketBeat.com, Regeneron Pharmaceuticals presently has a consensus rating of “Moderate Buy” and a consensus price target of $802.18.

Read Our Latest Stock Analysis on REGN

Regeneron Pharmaceuticals Company Profile (Free Report)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses technologies involving genetics, antibodies and other biologic treatments to advance therapies in areas such as eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease and rare disorders.

Regeneron’s marketed medicines include EYLEA and EYLEA HD for retinal diseases, Libtayo for certain cancers, Praluent for cardiovascular disease, Evkeeza for homozygous familial hypercholesterolemia and Veopoz for a rare immune disorder.

Featured Articles Five stocks we like better than Regeneron Pharmaceuticals Aeluma’s Selloff Could Be Setting Up Its Next Big Move Crypto Bill Stalls, Smart Money Calls: Time to Buy the Dip? The September Scramble: Find Sanctuary in These 3 Defensive Dividend Stocks The Fed’s Rate Hike Could Backfire If Oil Prices Collapse Want to see what other hedge funds are holding REGN? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN – Free Report).

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2026-09-16 07:28 1mo ago
2026-09-14 09:37 1mo ago
REGN Investors Have Opportunity to Lead Regeneron Pharmaceuticals, Inc. Securities Fraud Lawsuit with SBS Law
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
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LOS ANGELES--(BUSINESS WIRE)--Schall, Brown & Schwartz LLP (“SBS”), a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Regeneron Pharmaceuticals, Inc. (“Regeneron” or “the Company”) (NASDAQ: REGN) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Shareholders who purchased shares of REGN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery.

CLASS PERIOD: August 1, 2025 to May 15, 2026

DEADLINE: September 14, 2026

If you are a shareholder who suffered a loss, click here to participate.

CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. Regeneron led investors to believe that its Phase III Fianlimab-Libtayo Study was likely to succeed by achieving its primary endpoint. The Company utilized flawed statistical assumptions. In fact, the Company failed to demonstrate clinical differentiation from other therapies. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. When the market learned the truth about Regeneron, investors suffered damages.

We also encourage you to contact Brian Schall or David Schwartz of Schall, Brown & Schwartz LLP, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com, or by email at [email protected].

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

Join the case to recover your losses

WHY SBS? Schall, Brown & Schwartz LLP represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. Bringing together the extensive experience and diverse skillsets of founding partners Brian Schall, Andrew Brown, and David Schwartz, SBS is dedicated to aggressively advocating for every investor.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

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2026-09-15 16:49 1mo ago
2026-09-15 08:49 1mo ago
Novo Nordisk vs. Regeneron Pharmaceuticals: Which Healthcare Stock Is a Better Buy in 2026?
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
The race for pharmaceutical dominance often centers on chronic disease management. For investors, deciding between Novo Nordisk (NVO -1.70%) and Regeneron Pharmaceuticals (REGN -1.53%) requires a close look at their unique market strengths.

Novo Nordisk focuses heavily on metabolic disorders, particularly diabetes and weight loss, where it holds a massive global share. Regeneron leverages its proprietary technologies to develop treatments for eye diseases, cancer, and inflammatory conditions. Comparing these two giants reveals different approaches to growth and risk.

The case for Novo NordiskNovo Nordisk operates as a specialized leader among pharmaceutical stocks focusing on chronic disease care. Its primary focus remains on diabetes and obesity, where it provides essential medicines like insulin and GLP-1 treatments to patients in roughly 170 countries. Its latest annual report, filed for 2025, noted a workforce of approximately 68,800 people dedicated to these therapeutic areas. While major customers are not specifically disclosed in SEC filings, the company relies on a diverse base of healthcare providers and distributors globally.

In FY 2025, revenue reached nearly $47.7 billion, representing a 6.4% increase over the previous year. This growth follows a significant expansion in its obesity care portfolio during prior fiscal periods. The firm reported net income of close to $15.8 billion for the year. This resulted in a net margin of approximately 33.1%. A net margin measures how much profit a company keeps for every dollar of sales generated after all expenses are paid.

As of its December 2025 balance sheet, the debt-to-equity ratio is roughly 0.7x. This metric compares total liabilities to shareholder equity to assess financial leverage. The current ratio, which measures the ability to pay short-term obligations with short-term assets, sits at approximately 0.8x. For the fiscal year, free cash flow was nearly $4.5 billion. Free cash flow is the cash a business generates after paying for its operations and capital expenditures.

Regeneron Pharmaceuticals focuses on inventing and commercializing medicines for serious conditions, including eye diseases and rare genetic disorders. The company relies on a concentrated group of distributor customers, with two entities accounting for roughly 77% of gross product revenue in 2025. Customer concentration like this adds a layer of risk to the business. To manage its global presence, the firm maintains strategic partnerships with Sanofi (SNY -1.45%) and Bayer for its lead products. In July 2026, it expanded its pipeline by collaborating with Telix Pharmaceuticals (TLX +10.22%) for cancer therapies.

In FY 2025, revenue reached approximately $14.3 billion, which was a 1% increase over the previous fiscal year. It reported net income of nearly $4.5 billion for the period. This produced a net margin of roughly 31.4%, showing that the company retains nearly a third of its revenue as profit. The company has maintained steady profitability despite facing increased competition in its core therapeutic areas.

As of its December 2025 balance sheet, the debt-to-equity ratio is close to 0.1x, indicating a very low level of total debt relative to equity. The current ratio stands at approximately 4.1x, suggesting a high degree of liquidity for meeting short-term debts. For the fiscal year, free cash flow was nearly $4.1 billion. This represents the actual cash available to the company after it has funded its ongoing operations and necessary equipment purchases.

Risk profile comparisonNovo Nordisk faces risks primarily associated with its heavy reliance on the metabolic health market. As competition in the GLP-1 space intensifies from rivals like Amgen (AMGN -0.54%) and AstraZeneca (AZN -0.02%), pricing pressures could impact future growth. Additionally, the company must manage complex global supply chains to meet the soaring demand for its injectable treatments. Regulatory shifts in drug pricing, particularly in the United States, also pose a continuous threat to its high net margins.

Regeneron faces significant revenue concentration, as it is highly dependent on sales of EYLEA and Dupixent. Biosimilar competition began impacting EYLEA sales following the expiration of its U.S. regulatory exclusivity in May 2024. The company is also navigating multiple securities fraud class action lawsuits alleging that investors were misled about clinical trial risks. Furthermore, Regeneron relies heavily on Sanofi and Bayer for commercialization, and any disputes with these partners could disrupt operations. Regulatory delays for candidates like itepekimab also present hurdles to its product pipeline.

Valuation comparisonRegeneron appears to trade at a slight premium based on its P/S ratio, while Novo Nordisk offers a lower multiple relative to its Forward P/E and future earnings estimates.

MetricNovo NordiskRegeneron PharmaceuticalsForward P/E12.5x14.3xP/S ratio4.0x5.6xValuation metrics sourced from Financial Modeling Prep (FMP) and may differ from other data providers.

Which stock would I buy in 2026?I'd go with Regeneron. Its most recent quarter was one of the strongest in the company's history, with every major drug hitting record sales simultaneously. Dupixent grew at an extraordinary pace across all nine of its approved uses, EYLEA HD surpassed its older predecessor in U.S. sales for the first time, and Libtayo posted record global revenue. The company beat earnings estimates by a wide margin and is entering the second half of the year with a step-up in collaboration revenue from its Sanofi partnership. That is a business firing across every product line at once.

Novo Nordisk is not without its strengths. The Wegovy pill captured the vast majority of the U.S. oral obesity market since launch, treating more patients than ever before, and the company raised its full-year outlook. But pricing pressure from the U.S. government, reduced Medicaid coverage for obesity drugs, and intensifying competition from Eli Lilly are creating headwinds that are expected to weigh on results through the rest of the year.

For investors with patience and a long horizon, Regeneron's diversified, multi-drug growth story is a more comfortable foundation than a company navigating significant pricing and competitive pressure on its most important product.
2026-09-15 02:07 1mo ago
2026-09-14 20:31 1mo ago
Regeneron Pharmaceuticals, Inc. (REGN) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Regeneron Pharmaceuticals, Inc. (REGN) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript
2026-09-15 02:07 1mo ago
2026-09-14 22:03 1mo ago
Regeneron Highlights Dupixent Growth, Cemdisiran Catalysts and EYLEA HD Momentum
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
Amylyx Stock: Why the Full Pipeline Story MattersRegeneron Pharmaceuticals NASDAQ: REGN outlined growth opportunities for Dupixent, pipeline catalysts for cemdisiran and continued commercial momentum for EYLEA HD during the Morgan Stanley Global Healthcare Conference.

Marion McCourt, Regeneron’s EVP and head of commercial, said Dupixent’s growth opportunity is supported by patient demand across nine approved U.S. indications. While Sanofi independently raised its 2030 Dupixent sales guidance to EUR 25 billion from EUR 22 billion, McCourt said Regeneron shares the ambition to expand access to the therapy globally.

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Dupixent Growth Across Indications Ozempic, Mounjaro, Wegovy, or Zepbound? This ETF Holds Them AllAtopic dermatitis remains Dupixent’s largest indication, accounting for about half of total Dupixent net sales, according to McCourt. However, she said the U.S. market has reached only “high teens, maybe 20%” penetration, leaving substantial unmet need.

McCourt said patient adherence has remained high because patients can experience returning symptoms, including itch and lesions, when treatment is interrupted. She also pointed to Dupixent’s potential benefits for patients with multiple type 2 inflammatory diseases, such as atopic dermatitis alongside asthma or chronic rhinosinusitis with nasal polyps.

Pfizer Adds to Its Big Bet on Weight Loss DrugsBeyond atopic dermatitis, McCourt identified COPD as Dupixent’s most successful respiratory launch and said chronic spontaneous urticaria, or CSU, has shown what she described as the company’s second-best trajectory among dermatologists. She also cited eosinophilic esophagitis, bullous pemphigoid and prurigo nodularis as important indications serving patients with previously limited treatment options.

Ryan Crowe, SVP of investor relations and portfolio strategy and intelligence, said Regeneron aims to sustain leadership in immunology and inflammation through a pipeline that includes a long-acting IL-13 antibody, a longer-acting antibody targeting the same receptor as Dupixent, an IL-4 ligand program and an IL-4/IL-13 bispecific candidate. The company also has an undisclosed-target antibody in early development for genetically linked diseases that may include primary biliary cholangitis, systemic lupus, ulcerative colitis and Sjögren’s disease.

Chris Fenimore, Regeneron’s EVP of finance and CFO, said the company continues discussions with Sanofi regarding the future structure of their collaboration. He said both companies are seeking to leverage the value created by Dupixent, though he did not provide timing for a potential update.

Capital Allocation and Business Development Fenimore said Regeneron remains active in business development and is not limited to platform or early-stage transactions. While the company sees advantages in platforms capable of producing multiple products, it has also evaluated later-stage opportunities, he said.

The company’s decision-making is driven by scientific potential, commercial opportunity, development cost and the speed with which an asset could reach the market, Fenimore said. He added that Regeneron remains disciplined on valuations and is willing to deploy capital when an opportunity meets its criteria.

On shareholder returns, Fenimore said the company does not view its dividend as a major capital-return mechanism or a near- to medium-term dividend-growth story. Regeneron began its dividend program at $0.88 per share in 2025 and increased it to $0.94 per share in 2026, representing annual payouts of roughly $400 million.

The company repurchased approximately $2 billion of shares in the first half of the year, including $1.2 billion in the second quarter, and had $2.5 billion remaining under its authorization. Fenimore said buybacks are valuation-sensitive, with purchases increasing when the stock trades at lower levels.

Cemdisiran Readouts and Launch Planning Regeneron expects an FDA decision on cemdisiran for myasthenia gravis in November. McCourt said the company has established a neurology business unit and expects to be launch-ready if the product is approved. She highlighted cemdisiran’s every-three-month dosing schedule, as well as its clinical profile, safety and mechanism of action.

Crowe said a Phase III readout in paroxysmal nocturnal hemoglobinuria, or PNH, is expected in the fourth quarter. The study evaluates cemdisiran combined with pozelimab against eculizumab over 26 weeks, with co-primary endpoints of disease control measured by LDH and transfusion avoidance. Both endpoints must be met for the study to be positive.

Also in the fourth quarter, Regeneron expects an interim analysis from its geographic atrophy program. The study is evaluating systemic cemdisiran alone and in combination with pozelimab against placebo. Crowe said the 26-week analysis of the first 225 patients will assess the slope of geographic atrophy lesion size, safety and other endpoints. The results are intended to guide the ongoing 750-patient registrational cohort.

EYLEA HD Uptake and Competition McCourt said EYLEA HD represented about 60% of combined EYLEA and EYLEA HD franchise net sales in the second quarter, up from roughly 50% in the first quarter. She attributed uptake to label enhancements, including dosing options for retinal vein occlusion and longer durability, which she said provide the broadest label in the anti-VEGF category.

Regeneron expects additional competition and potential pricing pressure from 2 mg EYLEA biosimilars over time. Fenimore said the company continues to expect approval of a prefilled syringe from one or more contract manufacturing organizations by year-end.

Crowe said the timing of potential biosimilars for 8 mg aflibercept is difficult to predict. He noted that patent proceedings involving Alvotech are ongoing, with oral arguments scheduled for Dec. 4 and a Patent Trial and Appeal Board decision expected in early March. Regeneron believes its broader intellectual-property estate will be relevant to any biosimilar launch timing.

McCourt also said linvoseltamab has received encouraging early feedback in heavily pretreated, fourth-line-plus multiple myeloma patients. She said physicians have cited its efficacy, safety, ease of use and lower hospitalization requirements, while emphasizing that additional clinical studies will be important to support potential expansion into earlier treatment lines.

About Regeneron Pharmaceuticals (NASDAQ:REGN)Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses technologies involving genetics, antibodies and other biologic treatments to advance therapies in areas such as eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease and rare disorders.

Regeneron's marketed medicines include EYLEA and EYLEA HD for retinal diseases, Libtayo for certain cancers, Praluent for cardiovascular disease, Evkeeza for homozygous familial hypercholesterolemia and Veopoz for a rare immune disorder.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

Should You Invest $1,000 in Regeneron Pharmaceuticals Right Now?Before you consider Regeneron Pharmaceuticals, you'll want to hear this.

MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Regeneron Pharmaceuticals wasn't on the list.

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2026-09-14 18:47 1mo ago
2026-09-14 12:39 1mo ago
CLASS ACTION DEADLINE TONIGHT: Faruqi & Faruqi, LLP Reminds Regeneron (REGN) Investors of Securities Class Action Lawsuit Deadline on September 14, 2026
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
NEW YORK--(BUSINESS WIRE)---- $REGN #ClassAction--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) (NASDAQ: REGN) and reminds investors of the September 14, 2026 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and.
2026-09-14 18:47 1mo ago
2026-09-14 12:46 1mo ago
REGN DEADLINE ALERT: Hagens Berman Alerts Regeneron Pharmaceuticals, Inc. Investors to Today's September 14, 2026 Lead Plaintiff Deadline in Securities Class Action
REGN Regeneron Pharmaceuticals
FMP Stock News
Original source text
, /PRNewswire/ -- Hagens Berman Sobol Shapiro LLP alerts investors in Regeneron Pharmaceuticals (NASDAQ: REGN) that a securities class action lawsuit has been filed after its surprising revelations concerning a Phase 3 clinical trial of a therapy intended to treat patients with melanoma.

The news that the trial failed drove the price of Regeneron shares sharply lower and, along with the severe market reaction ($11 billion market cap wipeout), triggered the lawsuit which seeks to represent investors who purchased or otherwise acquired shares of Regeneron common stock between August 1, 2025 and May 15, 2026. 

National shareholder rights firm Hagens Berman is investigating the legal claims and urges Regeneron investors with substantial losses to submit your losses now. The firm also invites persons who may be able to assist in the investigation to contact its attorneys.

View our latest video summary of the allegations: youtu.be/rsW1-f8ARRs

Class Period: Aug. 1, 2025 – May 15, 2026
Lead Plaintiff Deadline: Sept. 14, 2026
Visit: www.hbsslaw.com/regn
Contact the Firm Now: [email protected]
                                         844-916-0895

Regeneron Pharmaceuticals, Inc. (REGN) Securities Class Action:

The litigation is focused on the propriety of Regeneron's repeated optimism about the state of- (and changes to-) its Phase 3 trial of Fianlimab in combination with Libtayo as a first-line treatment for metastatic or locally advanced melanoma (the "Study").

The Study's primary endpoint was progression-free survival ("PFS") and Regeneron has characterized the combination as a "potential blockbuster." "Events" – disease progression or death – determined the timing and statistical power of the primary PFS analysis.

The complaint alleges that Regeneron made false and misleading statements while failing to disclose critical information to investors. In particular, the lawsuit accuses the company and its management of not informing investors that the Study's preliminary statistical assumptions were flawed, the active treatment arm was not achieving meaningful differentiation over standard therapies, and achievement of its primary endpoint was unlikely.

Throughout the Class Period, Regeneron and the other defendants assured investors of their confidence in the Trial's achieving its primary endpoint even when events were slowing down. At one point, management said the slowing event rates are "because the test arms are performing well."

The truth began to emerge on April 29, 2026, when Regeneron first revealed that it decided to alter the Trial protocol such that "t]he primary analysis of progression-free survival will now consider all patients enrolled in the study with a minimum follow-up of 6 months."

One prominent analyst reportedly questioned whether the decision was made because, in contrast to management's expressed confidence, the "underlying PFS benefit may be insufficient to show statistical significance."

Then, on May 12, 2026, Regeneron admitted that the decision to alter the Trial protocol was made in response to "slow event rates," occurred nearly six months ago, and was "submitted it to all the global regulatory authorities in November, December timeframe."

Three days later, the final blow came. On May 15, 2026, Regeneron abruptly reported the "trial did not reach statistical significance of the primary endpoint of improvement in progression-free survival (PFS)."

"We're focused on whether Regeneron altered the Trial protocol without timely telling investors to intentionally mislead them because the defendants knew so-called blockbuster potential for the combination wasn't really there," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation of the pending claims in the suit.

If you invested in Regeneron and have substantial losses, or have knowledge that will assist the firm's investigation, submit your losses now » 

If you'd like more information and answers to other frequently asked questions about the Regeneron case and the firm's investigation, read more »

Whistleblowers: Persons with non-public information regarding Regeneron should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].

About Hagens Berman
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SOURCE Hagens Berman Sobol Shapiro LLP