BioNTech (BNTX +0.33%) rose to prominence several years ago thanks to its role in the coronavirus market. The company developed Comirnaty, one of the best-selling COVID-19 vaccines, with Pfizer (PFE +0.77%). However, vaccination rates have dropped significantly due to a combination of factors, including stricter market regulations. As a result, BioNTech's coronavirus business hasn't performed well recently. The good news is that the company's future no longer depends on its work in this industry. There is another much larger area BioNTech is targeting. Here's what investors need to know.
Image source: Getty Images.
The industry's largest therapeutic area The weight-loss market is grabbing headlines for its rapid growth. But the largest area in the industry by annual sales remains oncology. There are several reasons for that. Let's consider four of them. First, cancer is one of the world's leading causes of death. According to some estimates, in the U.S., one person in three will be diagnosed with cancer at some point in their lives. So, it is a fairly common disease with a significant annual death toll. Second, the oncology market is massive. There are dozens of types of cancer, and some corners of the industry remain underserved, which can attract even more drugmakers.
Third, because cancer is a life-threatening condition, regulators often grant cancer medicines in development special designations that can help speed up approval, a factor that incentivizes drugmakers to develop more of them. Lastly, cancer medicines often command high prices and can sometimes be administered over years. The cancer therapeutics space will continue to expand, and, according to some estimates, it will be worth $516.2 billion by 2035, with a compound annual growth rate of 9.3% over that period. That's the market where BioNTech is looking to carve out a meaningful niche. Can the company pull it off?
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BioNTech's exciting pipeline BioNTech has more than 25 phase 2 or phase 3 ongoing oncology clinical trials. This large pipeline should lead to at least a few approvals. Several of the company's products look particularly promising. Perhaps the most interesting is pumitamig, which BioNTech is developing in collaboration with Bristol Myers Squibb (BMY +1.23%). Pumitamig is a bispecific antibody, a class of medicines that bind to two different targets simultaneously, enabling it to direct the body's immune system to attack diseases like cancer more effectively than conventional antibodies.
Bispecific antibodies like pumitamig could gain significant traction in the coming years. The medicine has been dubbed a potential "Keytruda killer," or next-generation oncology medicines that could challenge Keytruda, currently the best-selling cancer drug on the market. Pumitamig is being investigated across cancers of the lung, kidney, breast, liver, colon, and rectum, among others. Pumitamig is well-positioned to earn approval within a couple of years and, eventually, generate well over $1 billion in annual sales. And that's just one of BioNTech's oncology candidates. Expect the company to improve its financial results significantly as it continues to make headway in this market.
Is BioNTech stock a buy? BioNTech's pipeline looks promising, even beyond its oncology-related work. The biotech is developing products in other areas, notably infectious diseases. It is working on vaccines for tuberculosis and even HIV. Clinical progress over the next few years could significantly strengthen its prospects. However, BioNTech's valuation is concerning. The stock is worth $23.2 billion, despite posting just $3.3 billion in revenue over the trailing-12-month period, and its sales are declining. The company isn't consistently profitable either.
The market appears to be placing a lot of faith in BioNTech's pipeline. That won't be a problem so long as the company's work in this area goes smoothly, but its share price could fall off a cliff at any sign of trouble. And there likely will be at least some signs of trouble -- it's hard for any biotech company to run a pipeline that large without encountering clinical or regulatory setbacks. My view is that, even though its pipeline looks exciting, BioNTech isn't attractive at current levels. Investors would be better off waiting for the stock to fall from its current levels before initiating a position.
Baader Bank Aktiengesellschaft lowered its stake in BioNTech SE Sponsored ADR (NASDAQ:BNTX – Free Report) by 10.4% in the 1st quarter, according to its most recent filing with the SEC. The fund owned 136,425 shares of the company’s stock after selling 15,914 shares during the period. BioNTech accounts for approximately 0.9% of Baader Bank Aktiengesellschaft’s holdings, making the stock its 21st biggest holding. Baader Bank Aktiengesellschaft owned 0.05% of BioNTech worth $11,997,000 at the end of the most recent reporting period.
A number of other institutional investors have also modified their holdings of BNTX. BNP Paribas Financial Markets grew its position in shares of BioNTech by 43.0% in the 4th quarter. BNP Paribas Financial Markets now owns 1,578,094 shares of the company’s stock worth $150,235,000 after acquiring an additional 474,796 shares in the last quarter. GSK plc bought a new stake in shares of BioNTech in the 4th quarter valued at approximately $84,711,000. Morgan Stanley raised its position in shares of BioNTech by 12.9% during the 4th quarter. Morgan Stanley now owns 680,669 shares of the company’s stock valued at $64,800,000 after acquiring an additional 77,653 shares in the last quarter. Bank of America Corp DE raised its position in shares of BioNTech by 344.4% during the 3rd quarter. Bank of America Corp DE now owns 573,356 shares of the company’s stock valued at $56,544,000 after acquiring an additional 444,332 shares in the last quarter. Finally, DZ BANK AG Deutsche Zentral Genossenschafts Bank Frankfurt am Main raised its position in shares of BioNTech by 2.9% during the 2nd quarter. DZ BANK AG Deutsche Zentral Genossenschafts Bank Frankfurt am Main now owns 492,045 shares of the company’s stock valued at $52,416,000 after acquiring an additional 13,788 shares in the last quarter. Institutional investors and hedge funds own 15.52% of the company’s stock.
Insider Buying and Selling In other BioNTech news, COO Sierk Poetting sold 50,000 shares of the firm’s stock in a transaction that occurred on Wednesday, April 22nd. The shares were sold at an average price of $110.56, for a total value of $5,528,000.00. Following the sale, the chief operating officer owned 399,387 shares in the company, valued at approximately $44,156,226.72. This trade represents a 11.13% decrease in their ownership of the stock. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Company insiders own 19.20% of the company’s stock.
BioNTech Trading Up 0.7% NASDAQ:BNTX opened at $92.16 on Tuesday. The firm has a market capitalization of $23.31 billion, a P/E ratio of -15.67 and a beta of 1.32. The business has a 50 day simple moving average of $91.32 and a 200 day simple moving average of $97.81. The company has a debt-to-equity ratio of 0.01, a current ratio of 8.80 and a quick ratio of 8.74. BioNTech SE Sponsored ADR has a 12-month low of $79.52 and a 12-month high of $124.00.
BioNTech (NASDAQ:BNTX – Get Free Report) last issued its earnings results on Monday, May 4th. The company reported ($2.26) earnings per share for the quarter, topping the consensus estimate of ($2.52) by $0.26. The firm had revenue of $136.71 million for the quarter, compared to analyst estimates of $207.42 million. BioNTech had a negative return on equity of 5.30% and a negative net margin of 44.39%.The firm’s revenue for the quarter was down 35.4% on a year-over-year basis. During the same period last year, the company earned ($1.73) earnings per share. Equities research analysts predict that BioNTech SE Sponsored ADR will post -5.79 EPS for the current year.
BioNTech declared that its Board of Directors has initiated a share repurchase program on Thursday, May 7th that allows the company to repurchase $1.00 billion in shares. This repurchase authorization allows the company to repurchase up to 4.2% of its shares through open market purchases. Shares repurchase programs are generally a sign that the company’s board of directors believes its stock is undervalued.
Analyst Upgrades and Downgrades A number of research firms have commented on BNTX. Morgan Stanley decreased their price objective on shares of BioNTech from $126.00 to $119.00 and set an “overweight” rating for the company in a report on Wednesday, July 8th. Canaccord Genuity Group dropped their target price on shares of BioNTech from $171.00 to $158.00 and set a “buy” rating on the stock in a report on Wednesday, May 6th. UBS Group upgraded shares of BioNTech from a “neutral” rating to a “buy” rating and raised their price target for the stock from $117.00 to $135.00 in a research report on Wednesday, May 27th. Sanford C. Bernstein reaffirmed a “market perform” rating on shares of BioNTech in a report on Friday, June 5th. Finally, HC Wainwright reaffirmed a “buy” rating and issued a $130.00 price target on shares of BioNTech in a report on Monday, April 27th. One equities research analyst has rated the stock with a Strong Buy rating, thirteen have assigned a Buy rating, four have issued a Hold rating and one has given a Sell rating to the company. According to data from MarketBeat, the stock presently has an average rating of “Moderate Buy” and a consensus target price of $129.12.
Get Our Latest Research Report on BioNTech
About BioNTech (Free Report)
BioNTech SE (NASDAQ: BNTX) is a Germany-based biotechnology company that develops next-generation immunotherapies and vaccines, with a primary focus on messenger RNA (mRNA) technology. Founded in 2008 and headquartered in Mainz, BioNTech advances a platform approach to design and manufacture therapeutics across oncology, infectious diseases and other high unmet-need areas. The company is publicly traded on the NASDAQ exchange and became widely known for its rapid development and global deployment of an mRNA-based COVID-19 vaccine in collaboration with Pfizer.
BioNTech’s core activities include discovery research, clinical development and manufacturing of mRNA-based medicines, personalized cancer immunotherapies, engineered cell therapies, and antibody- and protein-based therapeutics.
Further Reading Five stocks we like better than BioNTech The Ugliest Stocks in the Market Just Got a Very Expensive Vote of Confidence Is Domino’s Stock Serving Up a Buying Opportunity? A $1T Black Hole: SpaceX Eyes Pentagon AI to Break Free Why Gold Miners Could Be the Market’s Biggest Comeback Story Want to see what other hedge funds are holding BNTX? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for BioNTech SE Sponsored ADR (NASDAQ:BNTX – Free Report).
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Amova Asset Management Americas Inc. acquired a new position in shares of BioNTech SE Sponsored ADR (NASDAQ:BNTX – Free Report) in the 1st quarter, according to its most recent filing with the Securities & Exchange Commission. The fund acquired 77,694 shares of the company’s stock, valued at approximately $6,905,000.
A number of other large investors have also recently made changes to their positions in the stock. GSK plc acquired a new stake in shares of BioNTech during the 4th quarter worth approximately $84,711,000. BNP Paribas Financial Markets lifted its stake in shares of BioNTech by 43.0% in the 4th quarter. BNP Paribas Financial Markets now owns 1,578,094 shares of the company’s stock valued at $150,235,000 after purchasing an additional 474,796 shares during the period. Bank of America Corp DE boosted its holdings in BioNTech by 344.4% during the third quarter. Bank of America Corp DE now owns 573,356 shares of the company’s stock worth $56,544,000 after buying an additional 444,332 shares in the last quarter. Voloridge Investment Management LLC acquired a new stake in BioNTech during the fourth quarter valued at $41,656,000. Finally, Davern Capital Partners LP acquired a new stake in BioNTech during the fourth quarter valued at $35,340,000. 15.52% of the stock is owned by hedge funds and other institutional investors.
BioNTech Trading Up 0.7% Shares of BNTX opened at $92.16 on Tuesday. BioNTech SE Sponsored ADR has a 52-week low of $79.52 and a 52-week high of $124.00. The stock has a market cap of $23.31 billion, a PE ratio of -15.67 and a beta of 1.32. The firm’s fifty day moving average is $91.32 and its two-hundred day moving average is $97.81. The company has a quick ratio of 8.74, a current ratio of 8.80 and a debt-to-equity ratio of 0.01.
BioNTech (NASDAQ:BNTX – Get Free Report) last issued its earnings results on Monday, May 4th. The company reported ($2.26) earnings per share (EPS) for the quarter, beating the consensus estimate of ($2.52) by $0.26. BioNTech had a negative return on equity of 5.30% and a negative net margin of 44.39%.The company had revenue of $136.71 million during the quarter, compared to analysts’ expectations of $207.42 million. During the same period in the prior year, the business earned ($1.73) EPS. The firm’s quarterly revenue was down 35.4% on a year-over-year basis. Research analysts forecast that BioNTech SE Sponsored ADR will post -5.79 earnings per share for the current fiscal year.
BioNTech announced that its board has initiated a stock buyback plan on Thursday, May 7th that permits the company to repurchase $1.00 billion in outstanding shares. This repurchase authorization permits the company to reacquire up to 4.2% of its stock through open market purchases. Stock repurchase plans are often a sign that the company’s management believes its shares are undervalued.
Wall Street Analysts Forecast Growth Several analysts have commented on BNTX shares. Wells Fargo & Company dropped their price objective on BioNTech from $150.00 to $140.00 and set an “overweight” rating on the stock in a report on Wednesday, May 6th. UBS Group raised BioNTech from a “neutral” rating to a “buy” rating and upped their target price for the stock from $117.00 to $135.00 in a research note on Wednesday, May 27th. Truist Financial upgraded BioNTech to a “strong-buy” rating in a research report on Wednesday, March 25th. Morgan Stanley dropped their price target on shares of BioNTech from $126.00 to $119.00 and set an “overweight” rating on the stock in a research note on Wednesday, July 8th. Finally, Jefferies Financial Group reissued a “buy” rating on shares of BioNTech in a report on Monday, June 1st. One equities research analyst has rated the stock with a Strong Buy rating, thirteen have issued a Buy rating, four have assigned a Hold rating and one has assigned a Sell rating to the company’s stock. Based on data from MarketBeat, the company presently has a consensus rating of “Moderate Buy” and a consensus price target of $129.12.
View Our Latest Report on BioNTech
Insider Activity at BioNTech In other news, COO Sierk Poetting sold 50,000 shares of the stock in a transaction on Wednesday, April 22nd. The stock was sold at an average price of $110.56, for a total transaction of $5,528,000.00. Following the completion of the transaction, the chief operating officer directly owned 399,387 shares in the company, valued at approximately $44,156,226.72. This represents a 11.13% decrease in their position. The transaction was disclosed in a document filed with the SEC, which can be accessed through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders own 19.20% of the company’s stock.
BioNTech Company Profile (Free Report)
BioNTech SE (NASDAQ: BNTX) is a Germany-based biotechnology company that develops next-generation immunotherapies and vaccines, with a primary focus on messenger RNA (mRNA) technology. Founded in 2008 and headquartered in Mainz, BioNTech advances a platform approach to design and manufacture therapeutics across oncology, infectious diseases and other high unmet-need areas. The company is publicly traded on the NASDAQ exchange and became widely known for its rapid development and global deployment of an mRNA-based COVID-19 vaccine in collaboration with Pfizer.
BioNTech’s core activities include discovery research, clinical development and manufacturing of mRNA-based medicines, personalized cancer immunotherapies, engineered cell therapies, and antibody- and protein-based therapeutics.
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MAINZ, Germany, July 21 , 2026 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the second quarter 2026 on Tuesday, August 4, 2026. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update.
On July 7, Cathie Wood's Ark Genomic Revolution ETF (ARKG +0.39%) sold over 44,000 shares of BioNTech (BNTX 0.32%), a German immunotherapy maker. The next day, it sold over 78,000 shares, a transaction valued at around $7.4 million.
As of July 10, that left her asset management company with just 307 shares, valued at a little more than $28,000. Because Ark Invest holds positions worth millions of dollars and BioNTech is now the smallest holding in this entire exchange-traded fund (ETF), it may be fair to assume that Wood has moved on from BioNTech.
Image source: Getty Images.
What may have caused BioNTech to get the boot One thing to know about ARKG is that it's an actively managed ETF, so it's common for the fund to move in and out of stocks frequently.
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Because Wood's ETF has now sold most of its BioNTech shares, it appears to be moving on, freeing up capital for Ark Invest. BioNTech stock has underperformed this year; as of this writing, its price is down nearly 4% year to date and has dipped more than 17% over the last 12 months. But there are challenges ahead that could continue to send shares lower.
One is that revenue is expected to land somewhere between 2 billion euros ($2.2 billion) and 2.3 billion euros ($2.6 billion) in 2026, a significant decrease from the 2.9 billion euros ($3.3 billion) reported for 2025. That's largely due to an expected drop in revenue from its COVID-19 vaccine, developed in partnership with Pfizer.
Another financial issue is that BioNTech reported back-to-back net losses in 2024 and 2025, after a net profit of 900 million euros ($1 billion) in 2023. That trend of net losses will likely continue, as BioNTech already showed a net loss in its 2026 first-quarter earnings report.
There are also issues on the leadership front. BioNTech's co-founders, Uğur Şahin and Özlem Türeci, are leaving the company by the end of 2026. Şahin is the CEO, and Türeci is the chief medical officer, so those are significant roles to fill. What makes that leadership transition even more challenging is that BioNTech has been shifting its focus from vaccines to oncology treatments.
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Is it time to sell BioNTech? The move from Ark Invest is notable. While investors shouldn't automatically follow its lead in selling the stock, BioNTech is trying to overcome several challenges at once. The company has a promising clinical pipeline of more than 25 phase 2 or phase 3 trials in oncology, but it only has one commercial product -- that COVID vaccine with slumping sales. All of this is complicated by the need to find new leadership.
If you haven't invested yet, you may want to consider holding off on starting a position -- at least until new management is found and the drugs in the pipeline show more progress.
Dividend investing is a proven way to earn above-average long-term returns. That's why top dividend stocks often attract large crowds of investors and trade at a premium. However, it's possible to find quality income stocks that are reasonably -- or even attractively -- valued, perhaps because they have faced challenges from which they will recover, but the market has yet to catch on.
Let's consider two dividend stocks that fit this description: Pfizer (PFE +1.45%) and Bristol Myers Squibb (BMY +2.24%). For dividend seekers with $1,000 to spare -- that isn't saved for bills or emergencies -- here's why it would be a great idea to invest in these stocks.
Image source: The Motley Fool.
1. Pfizer In 2022, Pfizer became the first biopharmaceutical company to reach $100 billion in annual sales, mostly due to its dominance in the coronavirus market. But it's been pretty much downhill from there. The drugmaker was unable to sustain solid revenue from its COVID-19 products as vaccination and hospitalization rates declined. Also, Pfizer will face important patent cliffs by the end of the decade. The company's anticoagulant Eliquis, which it shares the rights to with Bristol Myers, will lose patent exclusivity.
It's not surprising, then, that the company has lagged broader equities recently. However, the next five years could be transformational for the pharmaceutical giant as it advances important pipeline candidates. Pfizer has a deep pipeline, and multiple "shots on goal" should allow it to launch brand-new, highly successful products, eventually, even amid occasional clinical setbacks.
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The company's oncology pipeline looks particularly attractive, with candidates such as PF'4404, an investigational medicine in a newer class of cancer drugs, bispecific antibodies. Unlike traditional monoclonal antibodies, the current standards of care in oncology, which target one disease marker, bispecific antibodies can target two at the same time, often making them more effective at finding and destroying cancer cells. Pfizer thinks PF'4404 could be a pipeline-in-a-drug, earning approval across several market niches.
The medicine is currently in phase 3 studies and could deliver important clinical wins in the coming years. And it's just one of many promising candidates in Pfizer's oncology pipeline. The company is also making solid progress with its weight loss pipeline, with some candidates currently in phase 3 studies. Meanwhile, even though Pfizer's financial results haven't been great, some of its products are performing well and should help push sales higher for the foreseeable future. The company's bladder cancer drug Padcev and its respiratory syncytial virus vaccine, Abrysvo, are good examples.
Pfizer's strong pipeline and resilient underlying business (despite some headwinds) mean it is unlikely to cut its dividend. It currently offers a forward yield of 7.1% and has increased its payouts by 51.3% over the past decade. Lastly, the stock is trading at just 8.2x forward earnings, versus an average of 18.2 for healthcare stocks. This blue chip dividend stock looks like a strong buy at current levels. And with $1,000, investors can buy 42 shares of Pfizer.
2. Bristol Myers Squibb After facing some patent cliffs in recent years, Bristol Myers has gotten back on the right track. The company's revenue is moving in the right direction again, albeit slowly. However, the pharmaceutical leader will face more patent cliffs by the end of the decade, notably for two of its best-selling drugs, Eliquis and Opdivo, a cancer medicine. Bristol Myers seems well-equipped to replace those two drugs and has already taken important steps in that direction, with the approval of a subcutaneous version of Opdivo that will contribute to its top-line well into the next decade.
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Elsewhere, Bristol Myers is partnering with Johnson & Johnson (JNJ +3.05%) to develop Milvexian, a next-gen anticoagulant that aims to be just as effective as competitors while avoiding the bleeding risk associated with typical anticoagulants. Milvexian has received the Fast Track Designation from the U.S. Food and Drug Administration, a program that helps expedite the review and approval of drugs that treat serious conditions and address a high unmet need.
This suggests that the data so far indicate Milvexian could be just as good as advertised. Further, Bristol Myers is looking to get into the bispecific antibody market and is working on a promising candidate, pumitamig, with BioNTech (BNTX +0.38%). Expect solid progress from these (and other) candidates in the next couple of years. And in the meantime, even with the looming major patent cliffs, Bristol Myers has a portfolio of newer launches that are performing well and should eventually help replace older medicines.
The company isn't at risk of cutting its dividend. Bristol Myers' forward yield is 4.3%, and it has increased its payouts by 65.8% over the past decade. Finally, with the stock trading at 9x forward earnings, now is a great time to buy. $1,000 is good for 17 shares at the stock's current price.
The logo of BioNTech is pictured at Biontech's research laboratory for individualised vaccines against cancer in Mainz, Germany, July 27, 2023. REUTERS/Wolfgang Rattay Purchase Licensing Rights, opens new tab
CompaniesBERLIN, July 3 (Reuters) - BioNTech (22UAy.DE), opens new tab has held confidential talks with potential buyers about the German sites that the COVID‑19 vaccine maker plans to close, which has now grown to four locations, the Handelsblatt newspaper reported on Friday.
The German company had said in May that it would close three sites in Germany - Idar-Oberstein, Marburg and Tuebingen - by the end of 2027, and also end operations in Singapore by the first quarter of next year, affecting up to 1,860 jobs.
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According to Handelsblatt, the Berlin-based BioNTech subsidiary JPT Peptides is also being put up for sale.
The maker of peptides used in immunology and drug discovery is no longer profitable, and BioNTech plans to close it by the end of this year, the report said, citing people familiar with the decisions.
BioNTech and JPT Peptides did not immediately respond to emailed requests for comment.
Writing by Miranda Murray; Editing by Lincoln Feast.
Our Standards: The Thomson Reuters Trust Principles., opens new tab
A sign marks the offices of Moderna in Cambridge, Massachusetts, U.S., July 22, 2025. REUTERS/Brian Snyder/File Photo Purchase Licensing Rights, opens new tab
BERLIN, June 17 (Reuters) - U.S. pharmaceutical company Moderna (MRNA.O), opens new tab is interested in investing in production facilities in Germany, with an eye on plants that its German rival BioNTech plans to close, CEO Stephane Bancel told the German business daily Handelsblatt on Wednesday.
"If we were to find the right partnership with the German government, these facilities would be an interesting option -compared with building a new one," Bancel said.
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Writing by Miranda Murray Editing by Tomasz Janowski
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While healthcare stocks have underperformed broader equities in recent years, there are still highly attractive companies in the sector worth consideration. However, other fairly popular healthcare players aren't worth investing in. Consider the following three healthcare stocks: Zoetis (ZTS 2.25%), BioNTech (BNTX +1.12%), and Intellia Therapeutics (NTLA 1.94%). The first two have lagged the market over the past year, while the last one has performed well. Even so, Zoetis and BioNTech are far more attractive stocks than Intellia Therapeutics for investors focused on the long game. Let me explain.
Image source: Getty Images.
A well-established animal health leader Let's start with Zoetis, a company that focuses on animal health. Over the past two years, it has faced some challenges, including increased competition for one of its core growth drivers -- Apoquel, a medicine for allergic itch in dogs -- as well as scrutiny over potential side effects for Solensia and Librela, which treat osteoarthritis (OA) pain in cats and dogs, respectively.
However, Zoetis should eventually bounce back. Even with stiffer competition for Apoquel, the company has a strong presence in this niche and estimates that millions of dogs remain untreated or undertreated.
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Meanwhile, it has earned approval for Portela and Lenivia, newer OA pain medicines for cats and dogs. These two also have the advantage of being long-acting options that can be administered every three months, compared to monthly for their predecessors.
These two should grab a decent share of the market. Meanwhile, in the long run, Zoetis should continue launching new products, as it has for a while, while capitalizing on increased spending on pets. Lastly, Zoetis is a fantastic dividend stock, having increased its payouts by 458% over the past decade, which makes it a top stock for income seekers.
An innovative biotech with a deep pipeline BioNTech hasn't performed well due to significant issues in the coronavirus vaccine market. Recent regulatory changes in the U.S. have made it harder for many people to get vaccinated. Even before that, this area was somewhat unpredictable.
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However, BioNTech is working on developing newer products. The company has a fairly impressive pipeline with more than 25 phase 2 or phase 3 clinical trials in oncology alone. Some of its candidates look particularly promising. Consider the company's BNT327, an investigational cancer medicine it is developing with Bristol Myers Squibb. This candidate is a bispecific antibody, a newer class of drugs. BioNTech believes BNT327 has the potential to set new standards of care across multiple indications.
Only time will tell if the biotech is right, but this and many other candidates are why the stock could bounce back and perform well over the next five years as it makes significant clinical and regulatory progress.
A high-risk gene editing specialist Intellia Therapeutics has made progress with its leading pipeline candidates over the past year. They include lonvo-z, a potential gene-editing medicine for hereditary angioedema -- a genetic disorder that causes painful episodes of swelling -- and nex-z, an investigational treatment for transthyretin amyloidosis, a rare condition in which abnormal protein clumps form around some organs, causing cardiovascular (and other) problems. Nex-z and lonvo-z are Both are undergoing phase 3 studies.
Nex-z hit a roadblock last year when regulators placed its clinical trials on hold due to suspected adverse reactions following the death of a patient. But the U.S. Food and Drug Administration lifted the hold, allowing Intellia to move forward.
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So, it seems like everything is going well for the biotech. However, it faces significant uncertainty. First, there is still the possibility that one -- or both -- of its late-stage assets will fail in ongoing studies. If that happens, the stock will fall off a cliff. Even if it doesn't, Intellia Therapeutics will face an uphill battle. Gene-editing treatments are expensive and difficult to administer. Between getting third-party payers on board and properly treating patients, it could be years before Intellia Therapeutics generates steady revenue from its products -- if it ever does. It will take even more time for the company to turn profitable. That's why the stock is very risky and not worth it for long-term investors right now.
MAINZ, Germany, April 21, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the first quarter 2026 on Tuesday, May 5, 2026. Additionally, the Company will host a conference call and webcast that day at 8:00 a.m. ET (2:00 p.m. CET) for investors, financial analysts and the general public to discuss its financial results and provide a corporate update. To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN will be provided. It is recommended to register at least one day in advance. The slide presentation and audio of the webcast will be available via this link. Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page in the Investor Relations section of the Company's website at www.BioNTech.com. A replay of the webcast will be made available shortly after the call and archived on the Company's website for 30 days following the call.
BioNTech SE Sponsored ADR (BNTX - Free Report) shares ended the last trading session 6.1% higher at $111.6. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 19% gain over the past four weeks.
The growing investor optimism related to the company’s novel investigative therapies, which are being developed for treating cancer and other serious diseases, might have driven the recent share price rally.
This company is expected to post quarterly loss of $2.52 per share in its upcoming report, which represents a year-over-year change of -38.5%. Revenues are expected to be $214.62 million, up 11.6% from the year-ago quarter.
While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
For BioNTech, the consensus EPS estimate for the quarter has been revised 27.4% lower over the last 30 days to the current level. And a negative trend in earnings estimate revisions doesn't usually translate into price appreciation. So, make sure to keep an eye on BNTX going forward to see if this recent jump can turn into more strength down the road.
The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
BioNTech is part of the Zacks Medical - Biomedical and Genetics industry. Genmab A/S Sponsored ADR (GMAB - Free Report) , another stock in the same industry, closed the last trading session 3% lower at $27.06. GMAB has returned 8.7% in the past month.
Genmab's consensus EPS estimate for the upcoming report has changed +2.2% over the past month to $0.15. Compared to the company's year-ago EPS, this represents a change of -51.6%. Genmab currently boasts a Zacks Rank of #3 (Hold).
Lockheed Martin (LMT 1.52%) posted Q1 earnings of $6.44 per share, missing estimates of $6.74, as heavy spending on production expansion and $1 billion in debt repayments weighed on results. Shares fell nearly 5% Thursday, though they’re up 6.6% year-to-date.
The cash burn explained: Free cash flow came in at negative $291 million, driven by production investments across 20+ facilities and $816 million in dividends—not deteriorating demand. Full year intact: Lockheed held its 2026 guidance: $29.35–$30.25 EPS and $6.5B–$6.8B in free cash flow, backed by a recent $4.7B Patriot interceptor contract. Metric (GAAP unless noted)Q1 2026 (12 weeks)Q1 2025 (13 weeks)Y/YEPS$6.44$7.28(11.5%)Revenue (billions)$18.0$18.00%Operating Margin, Aeronautics (Non-GAAP)8.9%10.2%(1.3 pp)Operating Margin, Missiles and Fire Control (Non-GAAP)13.7%13.8%(0.1 pp)Free Cash Flow (Non-GAAP, millions)($291)$955-130.5% Closing Bell 4:07 pm
Stocks closed lower Thursday as rising Middle East tensions pushed oil to its fourth straight gain. Brent crude climbed 3.1% to $105.07 a barrel on stalled U.S.-Iran diplomacy and threats in the Strait of Hormuz. The Nasdaq fell 0.9%; the S&P 500 and Dow each dropped 0.4%.
ServiceNow Takes the Biggest Hit: Shares of ServiceNow (NOW 0.71%) plunged 18% despite revenue growth — investors punished the company for trimming its projected operating margin. Microsoft (MSFT +0.11%) fell 4% in sympathy. IBM and Tesla Also Disappoint: IBM (IBM 1.13%) dropped 8.3% after holding revenue guidance flat. Tesla (TSLA +1.82%) shed 3.6% after announcing $25 billion in planned capital expenditures tied to AI and robotics. FDA Approves Regeneron’s Historic Hearing Cure 3:52 pm — REGN +2.64%
It’s a big day for Regeneron Pharmaceuticals (REGN +0.11%). The FDA approved Otarmeni, Regeneron’s gene therapy for children born deaf due to a rare genetic mutation, making it the first-ever gene therapy to restore hearing. In clinical trials, it improved hearing in 11 of 12 children. In an unusual move, Regeneron is offering the drug free in the U.S., a striking contrast to the million-dollar price tags common in gene therapy.
Free of charge, unprecedented: The condition affects just 20 to 50 U.S. newborns annually, but Regeneron aims to expand the drug's reach if further studies succeed. “We don’t feel like we have to figure out how to maximally price this so that we can try to make a windfall,” said George Yancopoulos, Regeneron’s co-founder and chief scientific officer. Same-day Fool rec: Regeneron is recommended in Motley Fool Health AI, the Fool's newest real-money portfolio, which was launched today. The buy report highlighted Regeneron’s genetic medicines pipeline and $5.9 billion R&D commitment; today’s approval is exactly the kind of pipeline payoff that thesis was built on.
Because apparently ruling the chip world wasn’t enough, Nvidia (NVDA +0.15%) is teaming up with nuclear startup Oklo (OKLO 0.64%) and the Los Alamos National Laboratory to use AI to advance nuclear research.
Not just vibes: The trio will develop AI models to validate nuclear fuel and study power generation for nuclear-powered AI factories—real, substantive work with serious infrastructure implications. "The company also shows significant strength in its technology, marked by substantial R&D investments, key project advancements, and strategic partnerships that position it competitively within the advanced nuclear sector," according to the Moneyball Hidden Gems primary database. The bull case for Oklo: HSBC (HSBC +2.15%) slapped a buy rating and $96 price target on Oklo stock, but investors should note Oklo has no meaningful revenue yet and needs regulatory approval before any of this becomes real. "Makes no sense for this stock to be gaining as it is. And yet it continues," member SoLongGoodbye wrote recently. Right now the stock remains essentially a bet on a future that hasn't arrived yet; a lot of optimism is already baked in.
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Meta Axes 8K Jobs, Kills 6K Openings 2:58 pm — META -2.50%
Mark Zuckerberg isn’t done swinging the axe. Meta (META 0.14%) is cutting 10% of its workforce — about 8,000 jobs — and canceling 6,000 open roles it had planned to fill. Layoffs begin May 20. It’s the latest in a string of cuts at Meta, which has been shedding metaverse-era headcount while pivoting hard toward AI. Microsoft (MSFT +0.11%) apparently got the memo too, announcing its first-ever voluntary buyout program Thursday for roughly 7% of its U.S. workforce.
Zuck’s AI Gap: Meta has openly trailed OpenAI, Alphabet (GOOG +0.44%), and Anthropic in generative AI — and Zuckerberg seems willing to spend (and cut) whatever it takes to close it. Big Tech’s New Math: Amazon (AMZN 1.24%) cut 16,000 jobs in January. The calculus is simple: fewer humans, more GPUs.
Texas Instruments (TXN +1.35%) beat on earnings and raised guidance, so the stock did what stocks do and jumped. Nothing shocking about that. The real story is whether they can actually pull off integrating Silicon Labs without tripping over themselves, and whether industrial demand holds up or rolls over next quarter. Management seems buttoned up and the cash generation is real.
Nice beat from a company that some people haven’t thought about since the 1980s…
Today's Lunchtime News 1:15 pm — SBUX +0.5%
Starbucks (SBUX +0.74%) is seeing early signs that last month's loyalty program overhaul is pulling in value-conscious customers, CNBC reports. Loyalty transactions accounted for 60% of the coffee chain's fiscal 2025 revenue, making the Rewards program central to CEO Brian Niccol's broader turnaround push.
Early traction: The new 60-star redemption option has become the program's most popular reward, with more than a quarter of all redemptions opting for the $2 discount. The first "free Mod Monday" more than doubled point redemptions versus earlier Mondays this year, and reusable cup usage for double-star bonuses jumped by double digits. Earnings on deck: Starbucks reports fiscal second-quarter results after the bell next Tuesday, with management expected to share more on loyalty trends and the broader turnaround. The chain's traffic struggles have been tied to losing active Rewards members, so any signs of a rebound there will be a key watch item. SBUX performance
Today +0.5%
1 Year +20.7%
5 Years -15.0%
Related articles
Starbucks Adds Bonuses and Tips in Turnaround Push Is Starbucks Brewing Something Good? Is Starbucks Finally Back?
ServiceNow's AI Wins Can't Calm the Street 1:25 pm — NOW -18.6%
By Matt Frankel, CFP®
Team Hidden Gems
ServiceNow (NOW 0.71%) beat its own guidance on revenue, earnings, and subscription growth, yet a Middle East-driven deal slowdown and looming margin pressure from its security acquisitions overshadowed the quarter. Revenue climbed 22% year-over-year to $3.67 billion and non-GAAP earnings per share rose 19.8% to $0.97. Adoption of its AI workflow tool Now Assist accelerated sharply, as the number of customers spending over $1 million on the product grew 130% year-over-year.
Delayed on-premises deal closings in the Middle East trimmed roughly 75 basis points off subscription growth, which management attributed to the ongoing Iran conflict. It also warned that integration costs from the Armis and Veza security acquisitions will weigh on margins until fiscal 2027. Those headwinds offset a $205 million bump to full-year subscription revenue guidance.
Shares are down roughly 17% in Thursday mid-day trading near $86.
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IBM Beats on Q1, but Consulting Stalls 12:20 pm — IBM -8.8%
By Matt Frankel, CFP®
Team Hidden Gems
International Business Machines (IBM 1.13%) beat expectations on both revenue and earnings, yet the market punished it for unchanged guidance and weakness in its consulting arm. Revenue grew 9% year-over-year to $15.9 billion and non-GAAP earnings per share jumped 19% to $1.91, ahead of Wall Street forecasts on both lines. The biggest upside surprise came from infrastructure, where a 51% surge in IBM Z mainframe sales helped segment profit more than double.
Software, the company's largest revenue contributor, grew 11% year-over-year on hybrid cloud and AI demand, and operating margins expanded to 29.8%. Consulting, however, grew only 1% in constant currency. That matters because the segment houses most of IBM's $12.5 billion generative AI book, where investors are most worried about AI-native competitors eating into IBM's advisory work. Despite the strong Q1 showing, management reaffirmed its full-year outlook for more than 5% constant-currency revenue growth and a roughly $1 billion free cash flow increase.
Shares are down about 9% in Thursday trading near $228.
Microsoft Cuts 7% of U.S. Workforce 12:10 pm — MSFT -3.3%
Microsoft (MSFT +0.11%) is launching its first-ever voluntary buyout program, targeting approximately 7% of its U.S. workforce as it aggressively reallocates resources toward artificial intelligence. The 51-year-old titan will offer retirement packages to senior directors and below whose age and tenure total at least 70. This strategic thinning comes as Microsoft, Alphabet (GOOG +0.44%), and Amazon (AMZN 1.24%) face immense capital expenditure requirements for data centers while disruptive coding AI threatens legacy software margins. To retain top talent amid this transition, Microsoft is also decoupling stock awards from cash bonuses, granting managers more flexibility to reward elite performers.
Streamlined Incentives: The move to five pay options instead of nine simplifies the annual review process, allowing the company to pivot compensation toward AI-critical roles. Fiscal Prudence: By opting for voluntary exits over forced layoffs, Microsoft aims to reduce its 228,000-person headcount while maintaining internal morale during a volatile period for software valuations. ServiceNow Plunges on War Headwinds 11:15 am — NOW -16.1%
ServiceNow (NOW 0.71%) shares plummeted 17% Thursday morning, dragging down peers like Salesforce (CRM 0.23%), Adobe (ADBE 6.75%), and Oracle (ORCL 0.05%). While the company matched first-quarter earnings estimates at $0.97 per share, management revealed that the ongoing conflict in Iran delayed several large on-premise deals. This geopolitical friction created a 75-basis-point headwind for subscription revenue, which grew 22% to $3.67 billion. Investors reacted sharply to the news, as the software sector already faces heightened scrutiny regarding its ability to maintain growth rates while navigating both global instability and the rapid transition toward generative artificial intelligence.
Collateral Damage Discovered: The sales slowdown at ServiceNow sparked a contagion effect across the industry, with Salesforce shedding 8% as traders price in similar international deal delays. AI Valuation Pressure: Despite strong headline numbers, software giants are being punished for any sign of weakness as the market weighs if AI will eventually commoditize core enterprise platforms. Paramount Triumphs in WBD Bidding War 11:10 am — PSKY -5.1%
Warner Bros. Discovery (WBD +0.37%) shareholders overwhelmingly approved a $31-per-share acquisition by Paramount Skydance (PSKY 0.19%) on Thursday, moving the blockbuster media merger toward a third-quarter close. The deal follows an intense bidding war involving Netflix (NFLX 1.20%) and Comcast (CMCSA +2.21%). Paramount's offer includes a $7 billion breakup fee and covers WBD's previous $2.8 billion penalty to Netflix. While the premium offers certainty in a volatile streaming landscape, investors expressed frustration over non-binding executive payouts. CEO David Zaslav is set to receive an $800 million "golden parachute," including a controversial $335 million tax gross-up, despite a formal shareholder vote rejecting the compensation package.
Strategic Consolidation Play: By folding HBO Max, CNN, and the Warner Bros. film studio into its portfolio, Paramount aims to build a "next-generation" scale capable of rivaling Disney (DIS 0.43%) in global streaming dominance. Regulatory Hurdles Remain: While investors and proxy firms like ISS are on board, the merger still requires federal sign-off, which could be complicated by the consolidation of major news and sports broadcasting assets. WBD performance
Today -0.2%
1 Year +227.4%
5 Years -29.0%
Hidden Gems Primary
Database Superscore
51
Top of the Morning 10:25 am — ISRG flat
By Sanmeet Deo
Team Rule Breakers
Intuitive Surgical (ISRG 0.50%) dropped its Q1 2026 results on April 21, and the numbers were hard to argue with. Revenue hit $2.77 billion, up 23% year over year, while non-GAAP earnings per share surged to $2.50, crushing estimates of $2.12. Procedures grew 17% globally, the Ion lung-biopsy platform jumped 39%, and management promptly raised full-year guidance. For good measure, the company bought back $1.1 billion of its own stock in a single quarter, the largest repurchase in company history.
The bull case is compelling. The most important detail in the report wasn't the topline beat, it was that revenue grew six percentage points faster than procedures. That gap is pricing power made visible, driven by the da Vinci 5 platform commanding higher ASPs and generating ~11% more utilization per system than its predecessor. As the installed base of 11,395 systems churns out high-margin instrument and accessory revenue every quarter, the flywheel keeps spinning faster. Japan's new reimbursement policy in June 2026 could add another growth leg.
The bear case has teeth too. China, once a promising growth frontier, is now effectively dead money until at least 2027, with domestic competition and policy headwinds showing no signs of abating. Tariffs are trimming roughly 100 basis points from gross margins. And a newly disclosed cybersecurity incident involving unauthorized customer data access introduces a tail risk management hasn't faced before.
At its current valuation, Intuitive already prices in a lot of perfection. The business is exceptional, the question is whether the stock gives you room to breathe.
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9:25 am — MEDP -23.2% in pre-market trading
By Andy Cross
Motley Fool CIO
Medpace (MEDP 1.77%) shares are under pressure today after reporting Q1 2026 earnings yesterday that exceeded estimates but left investors concerned over future business. Q1 EPS of $4.28 beat the $3.94 estimates. And revenue of $706.6 million outpaced expectations of $697.6 million. The contract research company also maintained its full-year 2026 guidance with revenues between $2.755 billion and $2.855 billion and EPS between $16.68 and $17.50.
The conference call is just going on as I write this, but some of the concerns are about the book-to-bill ratio, which dipped down to 0.88x from 1.04x last quarter and 0.9x a year ago. Book-to-bill measures future business relative to the current sales. Above 1 is better than not. Medpace's ratio this quarter was also below analysts' consensus estimate of 1.04x according to VisibleAlpha, a S&P GlobalMarket Intelligence company. And that estimate has trended down. So this 0.88x result comes as a bit of a surprise.
5:15 am — BNTX -0.69% in pre-market trading
By Morning Show host Thomas King, CFA
Team Rule Breakers
Pancreatic cancer is one of the deadliest. In 2019 and 2020, sixteen patients were treated with a cancer vaccine developed by BioNTech (BNTX +1.12%) and Genentech which was designed to stimulate their immune system to recognize and attack the cancerous cells. Of the sixteen patients treated, eight had a significant immune system response, and of these eight, seven were alive five years after receiving the vaccine. Seven of the total of sixteen patients (44%), and seven of the eight (88%) that had an immune response were alive five years later. This is a dramatic improvement from the typical five-year survival rate for pancreatic cancer, which is 13%. This was a small study with only sixteen patients, but the results are encouraging and the vaccine will now be tested in a larger group of patients in a Phase 2 study.
Opening Bell 9:35 am -- TSLA -2.6%, IBM -9.6%, NOW -15.9%
Wall Street is pulling back from Wednesday's record peaks as heavy-hitting tech earnings trigger a selective sell-off. While the S&P 500 and Nasdaq initially rallied on President Trump’s Iran ceasefire extension, disappointing reactions to corporate results have soured the mood. Tesla (TSLA +1.82%) shares reversed early gains to trade 3% lower after CEO Elon Musk projected a "substantial" surge in capital expenditures — hitting $25 billion for 2026 — to fund its shift into AI and robotics. Meanwhile, enterprise software giants IBM (IBM 1.13%) and ServiceNow (NOW 0.71%) are dragging on the indices, dropping 7% and 13% respectively, as investors question if current profit growth can sustain premium valuations amid ongoing geopolitical "heartburn."
Market indexes
S&P 500
-0.26%
Nasdaq
-0.43%
Dow
-0.45%
Netflix's $25B Buyback Signals Share Confidence 8:00 am -- NFLX +1.22% in pre-market trading
Netflix (NFLX 1.20%) is shifting its capital strategy from mega-mergers to shareholder returns, authorizing a new $25 billion share repurchase program following its exit from the $72 billion race for Warner Bros. Discovery (WBD +0.37%). The move comes as the streamer sits on $12.3 billion in cash--boosted by a $2.8 billion breakup fee from Paramount Skydance (PSKY 0.19%)--and looks to soothe investors following a tepid Q2 forecast and the impending departure of co-founder Reed Hastings. With acquisition "noise" behind it, Netflix is pivoting toward internal growth, including the recent purchase of AI film-tech firm InterPositive and a $20 billion content spend targeting live sports and advertising scale.
High-Yield Confidence: The buyback resumes with $6.8 billion still remaining from a previous 2024 plan, signaling management's belief that shares are undervalued after a recent 10% post-earnings dip to roughly $94. Scaling the Ad Tier: Analysts expect the ad-supported segment to double revenue to $3 billion in 2026, serving as a critical offset to slowing subscriber growth in mature markets like the U.S. and Canada.
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This Morning's Breakfast News 7:30 am -- IBM -7.48% in pre-market trading
IBM (IBM 1.13%) fell over 7% ahead of the market open despite quarterly results beating revenue and earnings estimates, as cautious guidance for the full year weighed on sentiment, something CEO Arvind Krishna blamed on broader geopolitical uncertainty.
"A lot of consumer companies are my clients": Krishna pointed out that higher inflation could see people spend less at companies such as Walmart (WMT +0.44%), which indirectly impacts IBM from reduced activity. "IBM's consulting business will be both threatened and supported by more sophisticated AI tools": In late February, TMF chief investment officer Andy Cross explained the Hidden Gems recommendation is under pressure from AI disruption, but "mainframes remain necessary infrastructure for hugely complex computing systems."
ICYMI: Wednesday's Scoreboard 6:00 am -- AOS unchanged in pre-market trading
A.O. Smith (AOS +0.72%) was the subject of the latest Scoreboard video.
China's Tech Giants Race to Back DeepSeek 5:30 am -- BABA -2.34% in pre-market trading
Chinese internet giants Tencent (TCEHY 0.20%) and Alibaba (BABA +0.02%) are in advanced talks to lead a landmark $300 million funding round for DeepSeek, a move that could value the AI pioneer at over $20 billion. The start-up, owned by hedge fund High-Flyer Capital Management, has gained global recognition for its high-efficiency, low-cost open-source models that rival U.S. leaders like Alphabet (GOOG +0.44%). Tencent has reportedly proposed acquiring up to a 20% stake, though negotiations remain fluid as DeepSeek resists ceding significant control. For the tech titans, the deal is a strategic grab for "agentic AI" leadership and a way to lock in demand for their respective cloud computing and data center services.
Benchmark Battle: DeepSeek's target valuation is being compared to MiniMax, another Chinese "super unicorn" recently valued by Goldman Sachs at $38.9 billion due to its extreme optimization of computing costs. Agentic Shift: DeepSeek is pivotally expanding into software "agents" capable of autonomous task execution, a sector where Alibaba recently consolidated its AI services into a single business unit to drive 2026 growth.
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Tilray Jumps on Cannabis Rescheduling Hopes 4:45 am -- TLRY +2.50% in pre-market trading
Tilray (TLRY 2.73%) shares surged over 11% as cannabis stocks rallied following reports that the Trump administration is expected to move toward reclassifying marijuana to Schedule III. The potential regulatory shift has sparked heavy buying interest across the sector.
Rescheduling catalyst drives sector rally: Reports indicate the administration is expected to finalize marijuana reclassification, which investors view as a major regulatory catalyst that could ease tax burdens and boost the industry. Analyst sees significant upside potential: A Wall Street analyst highlighted over 40% upside for Tilray based on its leading Canadian market share and growing beverage revenue, adding to the bullish sentiment surrounding the stock.
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Before the Opening Bell 4:30 am
Stock futures retreated Thursday as a breakdown in U.S.-Iran negotiations overshadowed President Trump's "indefinite" ceasefire. While the truce holds, a complete naval blockade of the Strait of Hormuz has pushed Brent crude back above $103 per barrel, fueling stagflation fears ahead of April's manufacturing data. Tesla (TSLA +1.82%) added to the volatility; despite a Q1 earnings beat, shares fell 2% after CEO Elon Musk jacked up 2026 capital expenditure guidance to $25 billion to fund a massive "Cybercab" and AI robotics push. As cash flow concerns mount, investors are pivoting to pre-market results from American Express (AXP +2.18%), Blackstone (BX +1.58%), and American Airlines (AAL +2.25%) to gauge consumer and industrial resilience.
The $25B Bet: Tesla's tripled capex run-rate targets six simultaneous production lines, including a dedicated "Optimus" humanoid robot facility in Austin set to begin large-scale output this August. Banking on the Premium: American Express is expected to post a 10% earnings jump to $4.01 per share, as its high-net-worth customer base remains largely insulated from war-related energy spikes. HSBC Holdings is an advertising partner of Motley Fool Money. American Express is an advertising partner of Motley Fool Money. This article was created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. Andy Cross has positions in Adobe, Alphabet, Amazon, Comcast, Mastercard, Medpace, Meta Platforms, Microsoft, Netflix, Nvidia, Salesforce, ServiceNow, Starbucks, Tesla, Walt Disney, and Warner Bros. Discovery. Sanmeet Deo, CFA has positions in Alphabet, Amazon, Intuitive Surgical, Medpace, Netflix, Tesla, and Walmart. Seth Jayson has positions in A. O. Smith, Amazon, Microsoft, Nvidia, Salesforce, ServiceNow, and Walt Disney. Thomas King, CFA has positions in Adobe, Alphabet, Amazon, BioNTech Se, Intuitive Surgical, Mastercard, Microsoft, Salesforce, Tesla, Texas Instruments, and Walt Disney. The Motley Fool has positions in and recommends A. O. Smith, Adobe, Alphabet, Amazon, Blackstone, DoorDash, International Business Machines, Intuitive Surgical, Mastercard, Medpace, Meta Platforms, Microsoft, Netflix, Nvidia, Oracle, Regeneron Pharmaceuticals, Salesforce, ServiceNow, Starbucks, Tencent, Tesla, Texas Instruments, Walmart, Walt Disney, and Warner Bros. Discovery. The Motley Fool recommends Alibaba Group, BioNTech Se, Comcast, HSBC Holdings, Lockheed Martin, and Tilray Brands and recommends the following options: long January 2028 $330 calls on Adobe, long January 2028 $520 calls on Intuitive Surgical, short January 2028 $340 calls on Adobe, and short January 2028 $530 calls on Intuitive Surgical. The Motley Fool has a disclosure policy.
BioNTech SE (Nasdaq: BNTX) today reported financial results for the three months ended March 31, 2026 and provided an update on its corporate progress.
The logo of BioNTech is pictured at Biontech's research laboratory for individualised vaccines against cancer in Mainz, Germany, July 27, 2023. REUTERS/Wolfgang Rattay/File Photo Purchase Licensing Rights, opens new tab
SummaryCompaniesBioNTech transfers COVID-19 vaccine production to PfizerCutbacks come after co-founders announced departures to start new ventureCompany plans $1 billion share buyback, cost cuts, reaffirms R&D budgetShares fall 6.1%FRANKFURT, May 5 (Reuters) - BioNTech (22UAy.DE), opens new tab said on Tuesday it would close sites affecting up to 1,860 jobs and buy back up to $1 billion worth of its shares, as the COVID‑19 vaccine maker pivots away from pandemic-era manufacturing and prepares for a leadership transition.
The German company, which reported on Tuesday that it fell further into the red in the first quarter, said it would close sites in Idar-Oberstein, Marburg and Tuebingen, Germany, as well as in Singapore. The closures are part of a production transfer of its COVID-19 vaccine to partner Pfizer (PFE.N), opens new tab this year.
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BioNTech shares were down 6.1% after its results and announcement of plant closures.
BioNTech, the initial inventor of the Western world's most commonly used immunisation shot during the pandemic, said in March that its two co-founders would leave by the end of this year to start a new venture.
After years of deals and hiring for a deeper development pipeline and a commercial build-up, CEO Ugur Sahin and Chief Medical Officer Oezlem Tuereci, the married couple behind the success, said at the time they would strike out on their own to pursue early drug research.
The exit from Idar-Oberstein, Marburg, and Tuebingen is planned by the end of 2027, while operations in Singapore are expected to end during the first quarter of 2027, the statement said.
For each site, BioNTech is exploring options including a partial or total sale, it added.
It acquired operations in Tuebingen as part of the takeover of domestic peer CureVac for about $1.25 billion, agreed in June last year.
BioNTech also said it would ramp up cost-cutting, potentially reaching about 500 million euros ($584.50 million) in annual savings in 2029.
Based on BioNTech's staff of about 8,400, about 22% would be affected by job cuts, predominantly in Germany.
In March last year, BioNTech unveiled plans to cut between 950 and 1,350 positions until 2027 and it was not immediately clear how many jobs have already been cut.
The company, which had 16.7 billion euros in cash and financial securities as of March 31, will also repurchase up to $1 billion of its shares over the next 12 months.
It reported a first-quarter net loss of 532 million euros, compared with a loss of 416 million in the year-earlier period.
The group reaffirmed a 2026 research and development budget of 2.2 billion to 2.5 billion euros.
($1 = 0.8554 euros)
Reporting by Patricia Weiss and Ludwig Burger, editing by Linda Pasquini and Susan Fenton
Our Standards: The Thomson Reuters Trust Principles., opens new tab
The company said it would exit operations at some manufacturing plants in Germany and Singapore, as well as sites it acquired as part of its CureVac takeover.
The stock’s decline comes amid a broader market rally, with major indices like the Nasdaq up by 1.19% and the S&P 500 gaining 0.72%.
• BioNTech stock is under selling pressure. What’s pulling BNTX shares down?
BioNTech Revenue Miss, Wider Net Loss Pressure SentimentIn its first-quarter financial results, BioNTech reported revenues of 118.1 million euros ($138 million), down from 182.8 million euros a year ago, missing the consensus estimate of $214.62 million.
The sales fell primarily due to lower sales of its COVID-19 vaccines.
The company also recorded a net loss of 531.9 million euros, compared to a net loss of 415.8 million euros in the prior year.
The COVID-19 vaccine maker reported an adjusted loss of 1.95 euros ($2.28), better than the Street’s loss expectation of $2.52.
“Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations,” said Ramón Zapata, CFO at BioNTech. “We are committed to a diligent capital allocation strategy that empowers us to pursue our goal of evolving into a leading biopharmaceutical company with multiple oncology products by 2030.”
Restructuring Plan Targets Cost Savings, Site ExitsBioNTech is planning to wind down operations at manufacturing sites in Idar-Oberstein, Marburg, Tübingen and Singapore, along with CureVac facilities, impacting up to 1,860 roles.
The exits from Idar-Oberstein, Marburg and Tübingen are targeted by end-2027, while Singapore operations are set to close in the first quarter of 2027. The company is evaluating divestment options for these sites, including partial or full sales.
The restructuring is expected to deliver phased cost savings, reaching roughly 500 million euros in recurring annual savings by 2029 at full run-rate.
BioNTech reiterated its FY2026 revenue guidance of 2 billion–2.3 billion euros ($2.33 billion–$2.68 billion), compared to the Wall Street estimate of $2.56 billion.
BNTX Stock Price Activity: BioNTech shares were down 3% at $96.37 at the time of publication on Tuesday, according to Benzinga Pro data.
Photo: Piotr Swat / Shutterstock
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The logo of BioNTech is pictured at Biontech's research laboratory for individualised vaccines against cancer in Mainz, Germany, July 27, 2023. REUTERS/Wolfgang Rattay/File Photo Purchase Licensing Rights, opens new tab
CompaniesBERLIN, May 6 (Reuters) - A German government spokesperson said on Wednesday that the loss of BioNTech vaccine production in the country can be offset by other companies.
He added that the government continues to assume that the vaccine supply to the population is guaranteed.
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BioNTech this week said it would close sites affecting up to 1,860 jobs, as the COVID-19 vaccine maker pivots away from pandemic-era manufacturing.
Reporting by Thomas Seythal Editing by Madeline Chambers
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BioNTech SE is downgraded to Sell due to declining COVID vaccine revenues, leadership exits, and pipeline uncertainty. BNTX faces €531.9m Q1 net loss, expects €2–3bn 2026 revenues, and plans €1bn share buyback amid €16.8bn cash reserves. Major staff cuts and site exits are underway, targeting €500m annual savings to support the oncology pivot.
MAINZ, Germany, May 7, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that it has authorized a new share repurchase program (the “Program”), under which the Company may repurchase American Depositary Shares (“ADSs”), each representing one ordinary share of the Company, for an aggregate amount of up to $1.0 billion. Repurchases under the Program may be made until and including May 6, 2027. BioNTech’s disciplined approach to capital allocation and strong financial position enables this authorization.
BioNTech expects to use the repurchased ADSs to satisfy obligations in the ordinary course of business. The Program is designed to enhance capital efficiency, support long-term value creation and maintain financial flexibility alongside BioNTech’s objective to become a multi-product company by 2030.
The commencement, timing and total amount of ADS repurchases will depend upon market conditions and may be made in open market purchases from time to time, with a focus on price efficient repurchases to ensure prudent deployment of capital. BioNTech expects to fund the Program using its existing cash resources.
“We are confident in the Company’s long-term growth prospects, and this share repurchase program is consistent with our capital allocation strategy and our commitment to sustainable value creation for our shareholders,” said Ramón Zapata, Chief Financial Officer at BioNTech. “At the same time, our disciplined approach to capital deployment enables us to maintain the financial strength necessary to advance our innovative pipeline and aim for self-sustaining growth in the years ahead.”
The Program has been designed to operate within the safe harbor provided by Rule 10b-18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the affirmative defense provided by Rule 10b5-1 of the Exchange Act.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the Company’s intent to repurchase, from time to time, the Company’s ADSs. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: changes in the market price of the Company’s ADSs, general market conditions and applicable securities laws.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
An outbreak of the hantavirus on a cruise ship recently sparked a bit of a rally in the pharmaceutical and biotech industries. While no one hopes this will become a global health crisis, if it does, those companies that develop and market effective vaccines for the hantavirus may be financially rewarded, so the argument goes. However, at this stage, it is likely not a good idea to buy into this rally. Let's consider three reasons why.
Image source: Getty Images.
1. It's not as contagious as the coronavirus While this is an evolving situation and we may not have all the facts yet, the information we have suggests that this is unlikely to become a global health crisis on the scale of the coronavirus pandemic. Here's why. COVID-19 spreads through respiratory droplets from an infected person. The hantavirus, by contrast, is primarily transmitted by contact with the saliva, droppings, or urine of infected rodents.
There is a known variant, the Andes virus, that can spread from person to person. Even that strain has a much lower transmission rate than COVID-19, according to health officials. The hantavirus can be deadly, just like the coronavirus. But its limited person-to-person transmission could make it easier to contain and help us avoid another pandemic. That means the market for hantavirus vaccines may be very limited.
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2. It's hard to pick the winners Even if the worst-case scenario happens and this turns into another pandemic, it still wouldn't be a good idea to jump into the biotech rally. Here's a key reason: It's almost impossible to predict which companies will successfully develop and market hantavirus vaccines. The experience of the COVID-19 pandemic is instructive here. Many companies tried to launch effective coronavirus vaccines. Most of them failed to develop a competitive vaccine in a timely manner and dominate the market. The list included small biotechs, such as Ocugen, and major pharmaceutical giants, like Sanofi and Merck.
The fact that Sanofi and Merck were not major winners here is especially noteworthy, given that both have strong vaccine businesses. So, one might have expected them to be among the leaders. This shows that even investing in well-established vaccine makers doesn't guarantee anything. For all we know, if the recent hantavirus outbreak becomes a pandemic, the companies that will succeed in developing effective vaccines in a timely manner may turn out to be under-the-radar corporations.
3. Picking the winners might still result in losses Let's go one step further: Suppose there is a pandemic, and an investor purchases shares of a company that successfully develops a vaccine for the hantavirus in a timely manner. Even under this scenario, market-beating returns aren't guaranteed. Below is the performance of four of the vaccine companies, those that dominated the COVID-19 market at its peak, since January 2020: Pfizer, Moderna, BioNTech, and Novavax.
PFE Total Return Level data by YCharts
Notably, two have underperformed the S&P 500 during this period -- Pfizer by a substantial margin. Investors focused on the long game shouldn't try to pick out which company might make the biggest splash in this hypothetical market. Investing in an ETF that tracks major indexes such as the S&P 500 or the Nasdaq is a safer way to achieve excellent returns over the long run.
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Some vaccine makers are still buys Moderna is one of those working on a hantavirus vaccine and has been doing so since before the recent outbreak on a cruise ship. While it may not be a buy for that specific reason, the company could have a bright future as it advances several of its current candidates through the pipeline. One of the most promising is mRNA-4157, an investigational personalized cancer vaccine. Moderna has plenty of other programs in the pipeline, and its mRNA platform, which enables it to develop vaccines faster than companies using traditional methods, is also a major strength.
Pfizer is another vaccine maker worth considering right now. The stock looks attractive on the dip, considering it has significantly replenished its pipeline and has a long list of pivotal trials it started over the past year or will kick off throughout 2026. Pfizer's shares could recover as its pipeline progresses through the end of the decade, making it a stock worth serious consideration.
4 Reasons Pfizer Could Be a Value Play You Can't MissBioNTech NASDAQ: BNTX used its virtual annual general meeting to outline a transition year marked by leadership changes, continued investment in oncology, a planned share repurchase program and a restructuring of its manufacturing network.
Chairman of the Supervisory Board Helmut Jeggle said the 2025 fiscal year was “a successful one” for the company, citing progress toward BioNTech’s goal of becoming a multi-product company by 2030. He said the company ended 2025 with cash and marketable securities totaling EUR 17.2 billion, giving it “substantial resources” for its next phase of development.
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Management Highlights Oncology Pipeline and BMS Partnership Moderna Dips on Q2 Earnings But Can It Rip on a Short Squeeze?Chief Executive Officer Professor Dr. Ugur Sahin, delivering what he described as his final annual general meeting address as CEO, said BioNTech’s strategy remains focused on two pillars: maintaining its COVID-19 vaccine business with partner Pfizer and using proceeds to advance a diversified development pipeline, particularly in oncology.
Sahin said BioNTech and Pfizer have delivered more than 5 billion COVID-19 vaccine doses worldwide since 2020. He added that BioNTech’s vaccine is distributed in more than 180 countries and regions and has a market share of more than 50% in key markets.
Novavax Plunges on Earnings Miss: Falling Knife or Buying Opp?In oncology, Sahin said BioNTech has more than 25 ongoing Phase 2 and Phase 3 studies, 17 clinical programs and a clinical evidence base that includes more than 4,000 patients. He said the company expects several data updates from key late-stage studies in 2026.
Sahin highlighted pumitamig, BioNTech’s next-generation bispecific immunomodulator, as the company’s “flagship program.” He said the candidate has shown anti-tumor activity across a broad range of cancers based on clinical data to date and may have potential as a combination partner with other agents.
BioNTech completed the acquisition of Biotheus in early 2025, bringing pumitamig fully into its pipeline, and in June 2025 entered into a global 50/50 development and commercialization collaboration with Bristol Myers Squibb. Sahin said the agreement includes a $1.5 billion upfront payment, $2 billion in additional unconditional payments and up to $7.6 billion in milestone payments.
Financial Outlook and Buyback Plan Chief Financial Officer Ramón Zapata said 2025 was a strong year for BioNTech, with total revenue of EUR 2.9 billion, slightly higher than the prior year despite lower COVID-19 vaccine revenue. The decline in vaccine revenue was partly offset by EUR 613 million recognized from the BMS collaboration.
Research and development expenses were about EUR 2.1 billion in 2025, slightly below the prior year, which Zapata attributed to portfolio management and cost sharing with BMS. For the first quarter of 2026, BioNTech reported revenue of EUR 118 million, compared with EUR 183 million a year earlier, reflecting lower COVID-19 vaccine demand. R&D expenses rose to EUR 557 million from EUR 526 million, while SG&A expenses increased to EUR 151 million from EUR 121 million.
BioNTech reaffirmed its 2026 guidance, expecting total revenue of EUR 2.0 billion to EUR 2.3 billion, adjusted R&D expenses of EUR 2.2 billion to EUR 2.5 billion and adjusted SG&A expenses of EUR 700 million to EUR 800 million.
Zapata also announced a share repurchase program of American Depositary Shares of up to $1 billion over the next 12 months. He said the program reflects “confidence in our science, capital management discipline, and a commitment to delivering long-term value for our shareholders.”
Manufacturing Consolidation to Affect About 1,800 Employees BioNTech executives also addressed the company’s planned manufacturing consolidation. Zapata said BioNTech identified sites where capacity is expected to become significantly underutilized or idle over the next 24 months and decided to exit operations at sites in Idar-Oberstein, Marburg and Singapore, as well as CureVac sites.
The decision affects approximately 1,800 colleagues, Zapata said. He added that BioNTech is exploring divestment options, including partial or full sales of the sites, and expects recurring annual savings could reach about EUR 500 million by 2029, excluding exit costs.
Sahin said the decisions were made “with a heavy heart” and after careful analysis. He said the company intends to seek socially responsible solutions for affected employees and is working with policymakers, scientific institutions and regional partners.
Zapata said commercial and clinical drug supply will not be affected. Future clinical manufacturing for mRNA-based candidates will be covered by BioNTech’s broader network, including Mainz, while commercial COVID-19 vaccine production will be handled by Pfizer from the end of 2026.
Leadership Changes and New Company Plans Jeggle said Jens Holstein retired as planned as chief financial officer on June 30, 2025, and was succeeded by Zapata on July 1. Ryan Richardson, former chief strategy officer, stepped down from the Management Board by mutual agreement effective Sept. 30, 2025. The Supervisory Board also extended the appointment of Chief Operating Officer Sierk Pötting through Dec. 31, 2027.
Kylie Jimenez, appointed chief human resources officer effective March 1, 2026, told shareholders that her role is to help BioNTech’s organization, leadership and talent evolve with its strategy as it builds toward becoming a global multi-product commercial biotechnology company.
Jeggle also addressed the previously announced departures of Sahin and Chief Medical Officer Professor Dr. Özlem Türeci, who are set to leave BioNTech at the end of the year after founding and building the company over 18 years. He said they plan to focus on a new company dedicated to next-generation mRNA candidates. In response to submitted shareholder questions, Jeggle said BioNTech’s intellectual property rights, including patents, trademarks and technology platforms, are assets of the BioNTech Group and do not belong personally to the co-founders.
Shareholders Approve AGM Resolutions Shareholders representing 92% of BioNTech’s registered share capital were present or represented at the meeting. No live shareholder questions were submitted during the general debate.
All management and Supervisory Board proposals on the agenda were approved by the required majorities. These included carrying forward the 2025 balance sheet profit, approving the compensation report, expanding the Supervisory Board from six to eight members, electing Supervisory Board members, renewing authorization for virtual annual general meetings, creating a new authorized capital 2026 and approving a domination and profit and loss transfer agreement between BioNTech SE and BioNTech Discovery GmbH.
About BioNTech NASDAQ: BNTXBioNTech SE NASDAQ: BNTX is a Germany-based biotechnology company that develops next-generation immunotherapies and vaccines, with a primary focus on messenger RNA (mRNA) technology. Founded in 2008 and headquartered in Mainz, BioNTech advances a platform approach to design and manufacture therapeutics across oncology, infectious diseases and other high unmet-need areas. The company is publicly traded on the NASDAQ exchange and became widely known for its rapid development and global deployment of an mRNA-based COVID-19 vaccine in collaboration with Pfizer.
BioNTech's core activities include discovery research, clinical development and manufacturing of mRNA-based medicines, personalized cancer immunotherapies, engineered cell therapies, and antibody- and protein-based therapeutics.
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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MAINZ, Germany, May 15, 2026 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) held its Annual General Meeting (“AGM”) today. A total of 92 per cent of the share capital was represented at the virtual assembly. All resolutions proposed on the agenda items put to the vote at today’s AGM were approved by a majority of the shareholders.
BioNTech is strengthening its focus on the Company’s growing late-stage oncology pipeline, while continuing its discovery and early research aimed at long-term innovation. Consequently, the Company's shareholders approved expanding the Supervisory Board from six to eight members and adding additional expertise: Prof. Iris Löw-Friedrich, M.D., Ph.D., and Susanne Schaffert, Ph.D., were elected as new members of the Supervisory Board.
Iris Löw-Friedrich has many years of expertise in the field of clinical development and broad experience in the scientific and medical fields. She also possesses knowledge in the areas of sales and commercialization, management, innovation, and international markets relevant to the Company.
She is an experienced Supervisory Board member and adjunct professor of internal medicine at the faculty of medicine at Goethe University in Frankfurt am Main, Germany.
Susanne Schaffert is a member of supervisory boards in the healthcare sector, including that of Merck KGaA. She possesses particular expertise in the field of oncology as well as in sales and commercialization with a focus on product launches. Her knowledge spans innovation, research and development, and organizational leadership and management.
Additionally, shareholders approved the extension of the mandates of BioNTech’s Supervisory Board members Helmut Jeggle, Prof. Anja Morawietz, Ph.D., and Prof. Rudolf Staudigl, Ph.D.
At a meeting held following the AGM, the Supervisory Board elected Helmut Jeggle as its Chairman.
The voting results for all agenda items can be viewed on the Annual General Meeting 2026 website under the section ‘Voting Results’. The speeches by Chief Executive Officer Prof. Ugur Sahin, M.D., Chief Financial Officer Ramón Zapata and the slides presented at the AGM 2026 can be found in section ‘Speeches and Presentations’ under the same link.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the potential benefits of appointed Supervisory Board members. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
Pumitamig data from the ongoing Phase 2/3 ROSETTA Lung-02 trial in first-line non-small cell lung cancer mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig in combination with chemotherapyGotistobart Phase 2 overall survival data in patients with platinum-resistant ovarian cancer add to the growing body of evidence supporting its potential as a chemotherapy-free treatment optionContinued advancement of late-stage oncology pipeline with 25+ Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as novel-novel combination trials across major cancer types MAINZ, Germany, May 22, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data and trial updates from its late-stage oncology pipeline and innovative combination programs at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting held in Chicago, from May 29 to June 02. Two oral presentations will highlight new data for key strategic assets pumitamig and gotistobart. In addition, four trial in progress poster presentations will illustrate advancement of the Company’s ongoing pivotal trials and novel-novel combination trials, including antibody-drug conjugates (“ADC”).
“Achieving more for patients with cancer through translating science into innovative therapies is our unwavering ambition at BioNTech,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “At this year’s ASCO, our presentations underscore our oncology strategy of building a diversified portfolio of complementary modalities delivering differentiated therapeutic profiles across tumor types with high unmet medical need. We are focused on accelerating key strategic programs, both as monotherapies and combinations with standard of care treatments, to deliver our first wave of oncology innovations to patients. Simultaneously, and building on this momentum, we are advancing novel-novel combination approaches, including ADC-based regimens, to unlock the full synergistic potential of our pipeline.”
Highlights of BioNTech’s late-stage oncology programs to be presented at ASCO 2026:
Pumitamig (BNT327/BMS986545) – an investigational bispecific immunomodulator combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company (“BMS”):
1L NSCLC: Data from the interim analysis of the Phase 2 dose-optimization part of the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) showed encouraging anti-tumor activity in first-line (“1L”) non-small cell lung cancer (“NSCLC”). The trial evaluated pumitamig plus chemotherapy in patients with non-squamous and squamous NSCLC without actionable genomic alterations and across PD-L1 expression levels. These data mark the third global data set to consistently show encouraging anti-tumor activity for pumitamig plus chemotherapy, adding to the reported global data in small cell lung cancer and triple-negative breast cancer. The results inform the ongoing pivotal Phase 3 part of ROSETTA Lung-02 evaluating pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Updated data from a later cut-off date will be presented in a rapid oral presentation. Gotistobart (BNT316/ONC-392) – an investigational tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”):
PROC: Data from the Phase 2 PRESERVE-004 clinical trial (NCT05446298) evaluating gotistobart plus pembrolizumab in heavily pre-treated patients with platinum-resistant ovarian cancer (“PROC”) showed durable anti-tumor activity and clinically meaningful overall survival outcomes. Together with a manageable safety profile, the results add to the growing body of evidence supporting gotistobart’s potential as a chemotherapy-free treatment option, complementing the recently announced data in second and later line squamous non-small cell lung cancer.
BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel treatment combination approaches. With more than 25 Phase 2 and Phase 3 clinical trials, including 13 ongoing pivotal trials as well as novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early to late-stage conditions.
All abstracts are available on the ASCO website. Further information on BioNTech’s late-stage oncology portfolio can be accessed here.
Full presentation details:
MedicineAbstract TitleAbstract Number/Presentation DetailsPumitamigPhase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PDL1 × VEGF-A bsAb) + chemotherapy in 1L NSCLCAbstract #8513
Rapid Oral Abstract Session
Lung Cancer - Non-Small Cell Metastatic
May 30, 2026, 1:15 - 2:45pm CDTPhase 2/3 trial of pumitamig (PD-L1 ×VEGF-A bsab) plus chemotherapy versus bevacizumab plus chemotherapy in previously untreated, unresectable, or metastatic colorectal cancer (ROSETTA CRC-203)Abstract #TPS3672
Poster Session
Genitourinary Cancer - Prostate, Testicular, and Penile
Poster Board: 229a
May 31, 2026: 9:00am-12:00pm CDTGotistobartOverall survival for patients with pre-treated platinum-resistant ovarian cancer receiving gotistobart in combination with pembrolizumabAbstract #5511
Rapid Oral Abstract session
Gynecologic Cancer
May 30, 2026: 8:00 - 9:30am CDTBNT326/YL202BNT326-01: A Phase 1b/2 trial of BNT326/YL202 (HER3 ADC) as monotherapy and in combination with pumitamig (anti-PD-L1 × VEGF bsAb) in patients with advanced solid tumorsAbstract #TPS3160
Poster Session
Developmental Therapeutics -Molecularly Targeted Agents and Tumor Biology
Poster Board: 294b
May 30, 2026: 1:30 - 4:30pm CDTBNT324/DB-1311BNT324-03: A Phase 3, randomized, open-label trial of BNT324/DB-1311, a B7H3 ADC, versus docetaxel in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)Abstract #TPS5137
Poster Session
Genitourinary Cancer - Prostate, Testicular, and Penile
Poster Board: 229a
May 31, 2026: 9:00am - 12:00pm CDTTrastuzumab pamirtecan
(BNT323/DB-1303)Fern-EC-01 (BNT323-01): A phase 3 trial of trastuzumab pamirtecan (HER2 ADC) versus investigator’s choice of chemotherapy in patients with previously treated, HER2-expressing, recurrent endometrial cancer (EC)Abstract #TPS5645
Poster Session
Gynecologic Cancer
Poster Board: 302b
June 1, 2026: 9:00am - 12:00pm CDT About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545) in multiple indications, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in multiple indications, the investigational B7H3-targeted ADC BNT324/DB-1311 in metastatic castration-resistant prostate cancer, the investigational HER2-targeted ADC trastuzumab pamirtecan (BNT323/DB-1303) in recurrent endometrial cancer, and the investigational HER3-targeted ADC BNT326/YL202 as monotherapy and in combination with pumitamig in NSCLC and advanced solid tumors; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
First investigational PD-(L)1xVEGF bispecific immunomodulator to present global data showing encouraging efficacy in combination with chemotherapy in first-line non-small cell lung cancer across PD-L1 expression levels and subtypes, highlighting its potential to set a new standard of carePumitamig plus chemotherapy showed robust and consistent antitumor activity in first-line non-small cell lung cancer at both evaluated dose levels, with higher confirmed objective response rates at the lower dose of 63.6% in the non-squamous and 72.7% in the squamous subtypesPumitamig is advancing through a comprehensive global Phase 3 development program in non-small cell lung cancer, including the actively enrolling pivotal Phase 3 part of the ROSETTA Lung-02 trial, along with two additional global Phase 3 trials MAINZ, Germany, and PRINCETON, USA, May 30, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced interim Phase 2 data from the global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) evaluating the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig (also known as BNT327 or BMS-986545) plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer (“NSCLC”).
The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level (TPS ˂ 1%, TPS 1 – 49%, and TPS ≥ 50%). The data are being presented today as a rapid oral presentation (abstract #8513) at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago.
“Despite significant immuno-oncology advances in the treatment of non-small cell lung cancer, most advanced diseases relapse on or after a PD-(L)1 checkpoint inhibitor treatment,1 indicating that targeting this immunologic pathway alone is insufficient to achieve durable responses,” said Solange Peters, M.D., Ph.D., Lead Investigator and Director of Oncology at the University Hospital of Lausanne, Switzerland. “I am encouraged by the efficacy signal with this bispecific approach, showing robust responses across subtypes and PD-L1 levels, supporting the continued investigation of pumitamig and its potential to deliver improved outcomes for a broad range of patients with NSCLC.”
The Phase 2 part of the ROSETTA Lung-02 trial evaluated pumitamig in two dose levels, in combination with chemotherapy. At this interim analysis at the April 13, 2026 data cut-off, among 40 response-evaluable patients with a median follow-up of 9.0 months, pumitamig plus chemotherapy showed a confirmed objective response rate (“cORR”) of 57.1% in patients with non-squamous NSCLC and 68.4% with squamous NSCLC with a disease control rate (“DCR”) of 100%. Encouraging anti-tumor activity was observed at both dose levels, with higher response rates at the lower dose showing a cORR of 63.6% for non-squamous and 72.7% for squamous NSCLC. Results were high at each PD-L1 expression level (cORR: 47.6% TPS ˂ 1%; 77.8% TPS 1 – 49 %; 100% TPS ≥ 50%).
Pumitamig plus chemotherapy demonstrated a manageable safety profile with a low discontinuation rate. Grade ≥ 3 treatment-related adverse events (“TRAEs”) were reported in 48.8% of patients and were considered pumitamig-related in 23.3%, leading to treatment discontinuation in four (9.3%) patients. Immune-related AEs (“irAEs”) occurred in 16 (37.2%) patients and grade ≥ 3 irAEs in two (4.7%) patients. Bleeding events were reported in nine (20.9%) patients, with only one event being grade 3.
“The data we are presenting today provide further evidence of the potential of pumitamig to enhance anti-tumor responses in advanced lung cancer, one of the most challenging indications, by simultaneously targeting PD-L1 and VEGF-A with a single molecule,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “Pumitamig has consistently shown efficacy in three global Phase 2 trials across PD-L1 expression levels. Together with our partner BMS, we are continuing to advance pumitamig in ongoing pivotal and novel-novel combination trials with the goal of delivering better outcomes for more patients.”
“We are committed to advancing the science of lung cancer with pumitamig and improving on the standard of care for people with this challenging disease,” said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb. “With one of the broadest registrational programs in the class, we are focused on accelerating the development of pumitamig together with BioNTech, with the goal of delivering meaningful benefit to patients, including those who have been left behind by current therapies.”
BioNTech and BMS are advancing a broad development plan for pumitamig in non-small cell lung cancer across disease stages and subgroups. In addition to the ongoing global ROSETTA Lung-02 trial, which is currently recruiting for the Phase 3 part of the trial, there are two additional global Phase 3 clinical trials in NSCLC currently enrolling. These include ROSETTA Lung-201 (NCT07361497), evaluating pumitamig compared to durvalumab following concurrent chemoradiation therapy in patients with unresectable stage III NSCLC; and ROSETTA Lung-202 (NCT07361510), evaluating pumitamig compared to pembrolizumab as a first-line treatment for patients with advanced PD-L1 ≥ 50% NSCLC. Pumitamig is also being investigated in combination with other novel investigative treatments for NSCLC, including in combination with investigational antibody-drug conjugates (“ADCs”) and other modalities.
About ROSETTA Lung-02
The global Phase 2/3 ROSETTA Lung-02 trial (NCT06712316) is evaluating pumitamig (BNT327/ BMS986545) in combination with chemotherapy in patients with first-line treatment of non-squamous and squamous non-small cell lung cancer without actionable genomic alterations and with any level of PD-L1 expression. In the Phase 2 dose-optimization part of the trial, patients were randomized 1:1 to 1400 mg or 2000 mg pumitamig plus histology-specific chemotherapy Q3W (non-squamous: carboplatin + pemetrexed; squamous: carboplatin + paclitaxel). The primary endpoints of the Phase 2 part of the trial are objective response rate (ORR) per investigator’s assessment (RECIST 1.1), best percentage change in tumor size from baseline, and safety. Key secondary endpoints include duration of response (DOR) and disease control rate (DCR). The Phase 3 part of the trial will evaluate pumitamig plus chemotherapy versus pembrolizumab plus chemotherapy. Based on the totality of the data, a pumitamig 1500 mg flat dose Q3W plus chemotherapy was selected for further evaluation in the Phase 3 part. The primary endpoint of the Phase 3 part of the trial is progression free survival (PFS) assessed by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS), ORR, DOR.
About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.
More than 2,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA LUNG-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA LUNG-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA BREAST-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA GASTRIC-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.
About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.2 Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.3 Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended March 31, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy may not achieve its primary study endpoint or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether pumitamig alone or in combination with chemotherapy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by Bristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
1. Mariniello A et al. BioDrugs, 2025 Feb 15;39(2):215–235.
2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.
3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.
Key Takeaways BMY's phase III SUCCESSOR-2 study showed mezigdomide cut progression or death risk by 52% in RRMM.BMY reported higher response rates for MeziKd, with 80.2% overall and 26.7% complete responses.BMY and BioNTech shared phase II pumitamig data showing strong first-line NSCLC activity. Bristol Myers Squibb (BMY - Free Report) reported phase III SUCCESSOR-2 results of CELMoD (cereblon E3 ligase modulation) mezigdomide.
These results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
SUCCESSOR-2 is an inferential, seamless phase II/III, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).
Mezigdomide is an oral CELMoD therapy developed using BMY’s targeted protein degradation platform.
More on BMY’s SUCCESSOR-2 ResultsResults showed MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS), representing a 52% reduction in the risk of disease progression or death compared with Kd.
The data revealed significant PFS benefits observed across both second- and third-line patients, including those with high-risk disease. The MeziKd regimen delivered markedly higher response rates, with an overall response rate of 80.2% versus 53.4% and complete response rates of 26.7% versus 8.9% for the control arm. Median overall survival has not yet been reached.
While the safety profile was consistent with prior experience, higher rates of Grade 3-4 adverse events, particularly neutropenia and infections, were reported.
BMY plans to share the results with health authorities.
BMY and Partner BNTX Present Data on PumitamigBMY and partner BioNTech (BNTX - Free Report) reported encouraging interim phase II results from the ROSETTA Lung-02 study evaluating pumitamig (BNT327/BMS-986545) plus chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC) at the ASCO.
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BNTX and BMY, designed to cooperatively bind to PD-L1 and VEGF-A.
The phase II part of the ROSETTA Lung-02 study evaluated pumitamig in two dose levels, in combination with chemotherapy.
The investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig plus chemotherapy showed robust and consistent antitumor activity in first-line NSCLC at both evaluated dose levels, with higher confirmed objective response rates at the lower dose of 63.6% in the non-squamous and 72.7% in the squamous subtypes.
Pumitamig plus chemotherapy demonstrated a manageable safety profile with a low discontinuation rate.
BioNTech and BMY are pursuing an extensive development strategy for pumitamig across multiple NSCLC settings. In addition to the ongoing global ROSETTA Lung-02 study, which is currently recruiting for the phase III part of the study, two additional global phase III studies are actively enrolling, targeting both unresectable stage III disease and first-line PD-L1–high advanced NSCLC. The broad clinical program, coupled with ongoing combination studies involving antibody-drug conjugates and other novel therapies, highlights pumitamig’s potential to become a major oncology franchise and a significant long-term value driver for both companies.
BMY Advancing a Promising Pipeline to Drive GrowthWe note that BMY boasts a deep and promising pipeline. Key pipeline candidates with multi-billion-dollar potential are milvexian (Oral factor XIa inhibitor), admilparant (LPA1 antagonist), pumitamig (PD-L1 x VEGF-A bispecific antibody) and iberdomide & mezigdomide (oral CELMoD protein degraders).
The company’s targeted protein degradation platform — built over two decades — also includes investigational approaches such as ligand-directed degraders and degrader antibody conjugates. These programs aim to tackle disease-driving proteins that were previously considered difficult to target with traditional drugs.
The FDA has accepted a new drug application for iberdomide in combination with standard treatment (daratumumab and dexamethasone) for RRMM, granting Breakthrough Therapy Designation and Priority Review, with a target action date of Aug. 17, 2026.
The company, in partnership with Johnson & Johnson, is developing milvexian for atrial fibrillation (AF) and secondary stroke prevention (SSP).
Shares of the company have gained 6% year to date compared with the industry’s growth of 0.3%.
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Concurrent with the first-quarter results reported in April, BMY highlighted the growing depth and diversification of its pipeline, with several pivotal phase III readouts expected in the second half of 2026, including milvexian in AF and SSP, Cobenfy in Alzheimer's disease psychosis, and iberdomide PFS data. Positive outcomes from these programs could further de-risk the company's long-term growth outlook, expand its portfolio, and support its goal of launching more than 10 new drugs and 30 lifecycle expansion opportunities by the end of the decade.
Management also emphasized ongoing efforts to improve R&D productivity, streamline clinical development, and strengthen the early and mid-stage pipeline, positioning the company for sustained innovation and future revenue growth as its legacy portfolio continues to be adversely impacted by the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
BMY’s Zacks Rank & Key PicksBMY currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 79.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from a loss of 88 cents to earnings of 6 cents. Over the same period, earnings estimates for 2027 have increased to 87 cents per share from 24 cents per share. IMCR shares have lost 16.8% year to date.
Key Takeaways RCUS will supply casdatifan for new treatment arms in BMY's phase I/II ROSETTA RCC-208 study.RCUS sees HIF-2 alpha inhibition with PD-L1 and VEGF-A blockade as a TKI-free kidney cancer option.RCUS expects PEAK-1 enrollment completion and a first-line metastatic ccRCC phase III launch by 2026. Arcus Biosciences (RCUS - Free Report) announced a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMY - Free Report) to evaluate casdatifan in combination with PD L1/VEGF A bispecific immunomodulator.
This collaboration is aimed at developing a novel treatment regimen that delivers more sustained tumor control in kidney cancer, a cancer of high unmet medical need.
Casdatifan is an oral, once-daily small-molecule HIF-2α inhibitor designed to provide deep and durable pathway suppression.
More on RCUS-BMY CollaborationPer the terms of the agreement, clinical-stage, global biopharmaceutical company Arcus will provide casdatifan for evaluationin BMY’s phase I/II ROSETTA RCC-208 study.
This study evaluates pumitamig (BNT327/BMS986545), an investigational PD-L1/VEGF-A bispecific antibody, being jointly developed by BMY and partner BioNTech (BNTX - Free Report) , alone or in combination with other potential treatment options in advanced renal cell carcinoma (RCC).
Under the collaboration, two new treatment arms evaluating casdatifan-based combinations will be incorporated into the ROSETTA RCC-208 study. The agreement is non-exclusive, with both companies retaining full development and commercialization rights to their respective programs.
Arcus believes the combination of HIF-2α inhibition with PD-L1 and VEGF-A blockade could provide a promising tyrosine kinase inhibitor (TKI)-free treatment option for kidney cancer patients. The partnership supports the company’s broader strategy of establishing casdatifan as a foundational therapy across multiple lines of treatment for clear cell renal cell carcinoma (ccRCC).
Early clinical studies have demonstrated encouraging antitumor activity and a favorable safety profile, supporting casdatifan’s evaluation in combination regimens.
Arcus is currently studying the drug across first-line, second-line, and late-line treatment settings through its ARC-20 platform study. It is also enrolling patients in the phase III PEAK-1 study, which compares casdatifan plus cabozantinib against cabozantinib alone in immunotherapy-experienced metastatic ccRCC.
Arcus expects to complete patient enrollment in the PEAK-1 study and initiate a phase III study in first-line metastatic ccRCC by the end of 2026.
Taiho holds development and commercialization rights for casdatifan in Japan and select Asian markets outside China, while Arcus Biosciences retains exclusive rights to the therapy in all other global territories.
In 2025, BMY collaborated with BioNTech for the global co-development and co-commercialization of pumitamig across numerous solid tumor types.
BNTX and BMY are advancing pumitamig through an extensive clinical development program that includes more than 20 ongoing or planned studies evaluating the therapy as both a standalone treatment and in combination with other anticancer approaches across more than 10 solid tumor types.
Arcus Biosciences’ Pipeline ProgramsRCUS has advanced several investigational therapies into registrational-stage clinical trials, including casdatifan, a HIF-2α inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer.
Shares of the company have gained 7.5% year to date against the industry's decline of 8.2%.
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RCUS had earlier collaborated with Gilead Sciences, Inc. (GILD - Free Report) to advance its pipeline.
However, in April 2026, Arcus announced that Gilead’s option rights under the companies’ 2020 collaboration agreement, as amended, will expire on July 14, 2026, after Gilead elected not to make the option continuation payment.
As a result, Gilead will no longer hold option rights to additional early-stage pipeline programs, including CCR6, CD89, and CD40L. However, the company will retain its existing time-limited options for several programs, including AB801, an investigational AXL inhibitor; AB598, an investigational anti-CD39 monoclonal antibody; AB102, an investigational MRGPRX2 antagonist; and an investigational TNF small-molecule inhibitor.
In March 2026, Arcus and AstraZeneca decided not to resume patient enrollment in eVOLVE-RCC02. This is a phase Ib/III study sponsored and managed by AstraZeneca that is evaluating casdatifan in combination with volrustomig, AstraZeneca’s investigational anti-PD-1/CTLA-4 bispecific antibody, for the treatment of first-line advanced or metastatic ccRCC.