Key Takeaways INCY is set to report Q2 results with revenue estimates at $1.40B and earnings expected at $1.85 per share.INCY may benefit from strong Jakafi demand, higher royalties and Opzelura growth with a one-time Q2 benefit.Incyte's newer products, including Niktimvo and Monjuvi, are expected to add to second-quarter revenues. Incyte Corporation (INCY - Free Report) is expected to beat expectations when it reports second-quarter 2026 earnings on July 28, before the opening bell. The Zacks Consensus Estimate for the to-be-reported quarter’s revenues is pegged at $1.40 billion, while the same for earnings is pinned at $1.85 per share.
Let’s see how things might have shaped up before the announcement.
Factors Likely to Influence INCY's Q2 ResultsIncyte primarily derives product revenues from the sales of its lead drug, Jakafi (ruxolitinib), in the United States, as well as from the sales of other marketed drugs. Its momentum is likely to have continued on the back of strong Jakafi sales, a first-in-class, selective JAK1/JAK2 inhibitor, in all approved indications (polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease [GvHD]).
The Zacks Consensus Estimate for Jakafi's second-quarter sales is pegged at $796.5 million.
Incyte also earns product royalty revenues from Novartis (NVS - Free Report) for the commercialization of Jakafi in ex-U.S. markets.
While Incyte markets Jakafi in the United States, Novartis markets the same drug as Jakavi outside the United States. INCY is expected to have received higher royalties from NVS in the to-be-reported quarter due to potentially higher Jakavi sales.
Year to date, Incyte shares have gained 18.1% compared with the industry’s 1.3% growth.
Image Source: Zacks Investment Research
Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
In the to-be-reported quarter, Opzelura (ruxolitinib cream) sales are expected to have been driven by continued growth in new patient starts and refills in the United States, for both its approved indications, atopic dermatitis and vitiligo. Incyte's second-quarter results are expected to benefit from its recent settlement with the CMS regarding Medicaid rebate rules for Opzelura. The agreement eliminates potential liabilities related to the application of line extension regulations, leading to a one-time, non-cash benefit of approximately $246 million in the second quarter from the reversal of previously accrued balances. The settlement should also improve Opzelura's gross-to-net performance going forward, and management is expected to update its financial guidance to reflect the impact.
The Zacks Consensus Estimate for Opzelura’s second-quarter sales is pegged at $214.7 million.
While Jakafi’s sales and royalties are the key catalysts for Incyte’s revenue growth, sales of other drugs like Minjuvi, Pemazyre and Iclusig, and Olumiant’s royalties from Eli Lilly (LLY - Free Report) are also likely to have contributed to Incyte’s top line. INCY has a collaboration agreement with LLY for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to Eli Lilly. It is approved for several types of autoimmune diseases.
Incyte acquired exclusive global rights to Monjuvi/Minjuvi (tafasitamab), initially approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma, from MorphoSys in 2024. Last year, the FDA approved Monjuvi for relapsed or refractory follicular lymphoma, expanding its label and boosting sales. Minjuvi also secured approvals for this indication in the EU and Japan in 2025.
The Zacks Consensus Estimate for Iclusig, Minjuvi/Monjuvi and Pemazyre’s second-quarter sales is pegged at $35.5 million, $50.6 million and $22.4 million, respectively. Incremental sales from Zynyz, too, are expected to have boosted Incyte’s revenues in the to-be-reported quarter.
Incyte and partner Syndax launched Niktimvo (axatilimab-csfr) in the United States in early 2025 after FDA approval for chronic graft-versus-host disease (cGvHD) patients who have failed at least two prior systemic therapies. Niktimvo is Incyte's second approved treatment for cGvHD (third-line). The Zacks Consensus Estimate for Niktimvo’s second-quarter sales is pegged at $63.5 million.
Higher research and development expenses, as well as increased selling, general and administrative costs, are likely to have escalated operating expenses in the second quarter of 2026.
INCY's Earnings Surprise HistoryIncyte has a mixed history of earnings surprises. The company beat earnings estimates in three of the trailing four quarters, while missing the same on the remaining occasion, delivering an average surprise of 18.26%. In the last reported quarter, INCY posted an earnings surprise of 31.16%.
Earnings Whispers for INCY StockOur proven model predicts an earnings beat for INCY this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat, which is the case here, as you will see below.
INCY’s Earnings ESP: Incyte’s Earnings ESP is +18.47% as the Most Accurate Estimate currently stands at $2.19, higher than the Zacks Consensus Estimate, which is pegged at $1.85. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
INCY’s Zacks Rank: INCY has a Zacks Rank #3 at present.
Another Stock With a Favorable CombinationHere is a stock worth considering from the healthcare space, as our model shows that this, too, has the right combination of elements to beat on earnings this reporting cycle.
ACADIA Pharmaceuticals (ACAD - Free Report) has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of ACAD have lost 7% year to date. The company’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 20.83%. Acadia is scheduled to report second-quarter results on Aug. 4.
Incyte (INCY - Free Report) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.
The earnings report, which is expected to be released on July 28, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.
While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.
Zacks Consensus EstimateThis specialty drugmaker is expected to post quarterly earnings of $1.85 per share in its upcoming report, which represents a year-over-year change of +17.8%.
Revenues are expected to be $1.4 billion, up 15.3% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.53% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core.
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Incyte?For Incyte, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +18.47%.
On the other hand, the stock currently carries a Zacks Rank of #3.
So, this combination indicates that Incyte will most likely beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Incyte would post earnings of $1.38 per share when it actually produced earnings of $1.81, delivering a surprise of +31.16%.
Over the last four quarters, the company has beaten consensus EPS estimates three times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Incyte appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
Key Takeaways HALO grants INCY the right to ENHANZE to support subcutaneous formulations of INCA033989.HALO will receive upfront, milestone and potential royalty payments if products are commercialized.HALO's ENHANZE aims to enable more convenient subcutaneous dosing regimens for patients. Halozyme Therapeutics (HALO - Free Report) announced that it has entered into a global collaboration and license agreement with Incyte (INCY - Free Report) to evaluate additional subcutaneous formulations of the latter’s INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody for a cancer indication.
With the partnership, the companies are looking to investigate additional subcutaneous formulations of Incyte’s INCA033989, utilizing Halozyme's proprietary ENHANZE drug delivery technology in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs).
The companies aim to develop more convenient subcutaneous dosing regimens that could improve the treatment experience for patients with mutCALR-expressing MPNs.
The deal gives Incyte the rights to develop and commercialize Halozyme’s ENHANZE drug delivery technology with its mutCALR development program and an option to nominate up to two additional targets for use with ENHANZE.
Per the agreement, Halozyme will receive an undisclosed amount of upfront payment from Incyte as well as additional milestone payments upon the achievement of specified development, regulatory and commercial milestones. Halozyme is also eligible to receive royalties on future net sales if a product is commercialized from this partnership using ENHANZE.
HALO’s Price PerformanceYear to date, shares of Halozyme have increased 14.6% compared with the industry’s rise of 3.2%.
Image Source: Zacks Investment Research
HALO’s ENHANZE Technology Aid RevenuesHalozyme’s ENHANZE drug delivery technology has been used in the development of subcutaneous formulations of various approved drugs through partnerships with large drugmakers. The company has several marketed partnered drugs based on this technology, including the subcutaneous formulation of J&J’s (JNJ - Free Report) Darzalex and Roche’s (RHHBY - Free Report) Phesgo.
Per the agreements, these companies have been granted worldwide license rights to develop and commercialize their products using ENHANZE technology. These deals generate royalties on sales of marketed drugs, milestone payments and annual license fees, which comprise Halozyme’s top line.
Halozyme’s top line also comprises product sales, royalty payments from Roche for Phesgo and J&J for subcutaneous Darzalex as well as revenues under collaboration agreements related to its ENHANZE technology.
Halozyme’s royalty revenues totaled $240.7 million in the first quarter of 2026, up 43% from the year-ago quarter’s level. This was mainly due to the robust demand for Phesgo, subcutaneous Darzalex and Vyvgart Hytrulo, on which it earns royalties.
Management expects royalty revenues to be in the range of $1.13-$1.17 billion in 2026, implying year-over-year growth of 30% to 35%.
HALO’s Zacks RankHalozyme currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Fifth Third Bancorp boosted its stake in shares of Incyte Corporation (NASDAQ:INCY – Free Report) by 145.2% in the 1st quarter, according to the company in its most recent disclosure with the SEC. The firm owned 27,289 shares of the biopharmaceutical company’s stock after buying an additional 16,160 shares during the quarter. Fifth Third Bancorp’s holdings in Incyte were worth $2,568,000 as of its most recent SEC filing.
A number of other large investors have also added to or reduced their stakes in the stock. Elyxium Wealth LLC purchased a new stake in Incyte in the fourth quarter worth $28,000. Smithfield Trust Co lifted its position in shares of Incyte by 135.0% during the 4th quarter. Smithfield Trust Co now owns 282 shares of the biopharmaceutical company’s stock valued at $28,000 after buying an additional 162 shares during the last quarter. MUFG Securities EMEA plc bought a new position in shares of Incyte during the 2nd quarter worth $32,000. CYBER HORNET ETFs LLC bought a new position in shares of Incyte during the 2nd quarter worth $33,000. Finally, Leonteq Securities AG purchased a new stake in Incyte in the 4th quarter worth about $35,000. Hedge funds and other institutional investors own 96.97% of the company’s stock.
Wall Street Analysts Forecast Growth A number of equities analysts have weighed in on INCY shares. Truist Financial increased their target price on shares of Incyte from $103.00 to $105.00 and gave the stock a “hold” rating in a research report on Monday, June 22nd. TD Cowen reissued a “hold” rating on shares of Incyte in a research report on Tuesday, June 9th. Royal Bank Of Canada upped their price target on shares of Incyte from $95.00 to $99.00 and gave the company a “sector perform” rating in a research note on Tuesday, July 7th. Oppenheimer reaffirmed a “market perform” rating and issued a $107.00 price objective on shares of Incyte in a report on Monday, June 8th. Finally, Barclays raised their price objective on shares of Incyte from $117.00 to $134.00 and gave the stock an “overweight” rating in a report on Tuesday, July 14th. Eight research analysts have rated the stock with a Buy rating and fourteen have assigned a Hold rating to the company’s stock. According to MarketBeat, Incyte currently has a consensus rating of “Hold” and an average price target of $109.95.
Read Our Latest Analysis on INCY
Incyte Stock Performance Shares of INCY opened at $115.65 on Tuesday. Incyte Corporation has a 12-month low of $67.17 and a 12-month high of $119.60. The company has a current ratio of 3.68, a quick ratio of 3.60 and a debt-to-equity ratio of 0.01. The company has a market cap of $23.10 billion, a PE ratio of 16.33, a price-to-earnings-growth ratio of 1.06 and a beta of 0.76. The stock has a 50-day moving average price of $105.29 and a 200-day moving average price of $101.16.
Incyte (NASDAQ:INCY – Get Free Report) last announced its earnings results on Tuesday, April 28th. The biopharmaceutical company reported $1.81 earnings per share (EPS) for the quarter, topping the consensus estimate of $1.38 by $0.43. The company had revenue of $1.27 billion during the quarter, compared to analyst estimates of $1.22 billion. Incyte had a net margin of 26.71% and a return on equity of 26.66%. The firm’s quarterly revenue was up 20.9% compared to the same quarter last year. During the same period in the previous year, the business earned $1.16 earnings per share. As a group, equities analysts forecast that Incyte Corporation will post 6.61 earnings per share for the current fiscal year.
Incyte Company Profile (Free Report)
Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company’s research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.
The company’s flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.
Read More Five stocks we like better than Incyte 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
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Bank of New York Mellon Corp lessened its holdings in Incyte Corporation (NASDAQ:INCY – Free Report) by 1.3% during the 1st quarter, according to its most recent filing with the Securities & Exchange Commission. The firm owned 989,709 shares of the biopharmaceutical company’s stock after selling 12,540 shares during the period. Bank of New York Mellon Corp owned about 0.50% of Incyte worth $93,151,000 at the end of the most recent reporting period.
A number of other institutional investors and hedge funds also recently made changes to their positions in the business. Geode Capital Management LLC increased its holdings in Incyte by 11.3% during the fourth quarter. Geode Capital Management LLC now owns 4,993,012 shares of the biopharmaceutical company’s stock valued at $491,500,000 after buying an additional 506,842 shares during the last quarter. Invesco Ltd. boosted its stake in shares of Incyte by 13.2% during the 4th quarter. Invesco Ltd. now owns 3,473,781 shares of the biopharmaceutical company’s stock worth $343,105,000 after acquiring an additional 405,611 shares during the last quarter. Arrowstreet Capital Limited Partnership boosted its stake in shares of Incyte by 13.7% during the 3rd quarter. Arrowstreet Capital Limited Partnership now owns 3,103,946 shares of the biopharmaceutical company’s stock worth $263,246,000 after acquiring an additional 373,298 shares during the last quarter. Morgan Stanley grew its position in shares of Incyte by 0.9% during the 4th quarter. Morgan Stanley now owns 2,663,823 shares of the biopharmaceutical company’s stock valued at $263,106,000 after acquiring an additional 23,087 shares during the period. Finally, Robeco Institutional Asset Management B.V. grew its position in shares of Incyte by 7.0% during the 4th quarter. Robeco Institutional Asset Management B.V. now owns 2,480,793 shares of the biopharmaceutical company’s stock valued at $245,028,000 after acquiring an additional 161,405 shares during the period. Hedge funds and other institutional investors own 96.97% of the company’s stock.
Analysts Set New Price Targets A number of equities analysts recently commented on the company. BMO Capital Markets raised their target price on Incyte from $94.00 to $112.00 and gave the stock a “market perform” rating in a report on Monday, July 13th. Citigroup reissued a “market perform” rating on shares of Incyte in a report on Wednesday, July 15th. Truist Financial upped their price target on Incyte from $103.00 to $105.00 and gave the stock a “hold” rating in a research report on Monday, June 22nd. Royal Bank Of Canada raised their price objective on Incyte from $95.00 to $99.00 and gave the stock a “sector perform” rating in a research note on Tuesday, July 7th. Finally, TD Cowen reaffirmed a “hold” rating on shares of Incyte in a research report on Tuesday, June 9th. Eight equities research analysts have rated the stock with a Buy rating and fourteen have given a Hold rating to the company’s stock. Based on data from MarketBeat.com, the stock has a consensus rating of “Hold” and an average price target of $109.95.
Read Our Latest Analysis on INCY
Incyte Stock Performance Incyte stock opened at $115.65 on Tuesday. The company’s 50-day moving average price is $105.29 and its 200-day moving average price is $101.16. The company has a quick ratio of 3.60, a current ratio of 3.68 and a debt-to-equity ratio of 0.01. The company has a market cap of $23.10 billion, a PE ratio of 16.33, a price-to-earnings-growth ratio of 1.06 and a beta of 0.76. Incyte Corporation has a twelve month low of $67.17 and a twelve month high of $119.60.
Incyte (NASDAQ:INCY – Get Free Report) last announced its quarterly earnings results on Tuesday, April 28th. The biopharmaceutical company reported $1.81 EPS for the quarter, beating analysts’ consensus estimates of $1.38 by $0.43. The firm had revenue of $1.27 billion during the quarter, compared to the consensus estimate of $1.22 billion. Incyte had a net margin of 26.71% and a return on equity of 26.66%. The firm’s revenue for the quarter was up 20.9% compared to the same quarter last year. During the same quarter last year, the firm earned $1.16 EPS. On average, equities research analysts forecast that Incyte Corporation will post 6.61 EPS for the current fiscal year.
Incyte Company Profile (Free Report)
Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company’s research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.
The company’s flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.
See Also Five stocks we like better than Incyte 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
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Andra AP fonden lessened its position in Incyte Corporation (NASDAQ:INCY – Free Report) by 34.6% during the 1st quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The firm owned 259,048 shares of the biopharmaceutical company’s stock after selling 137,252 shares during the quarter. Andra AP fonden owned about 0.13% of Incyte worth $24,382,000 at the end of the most recent quarter.
A number of other institutional investors and hedge funds have also recently bought and sold shares of the company. Nordea Investment Management AB boosted its stake in Incyte by 941.8% during the fourth quarter. Nordea Investment Management AB now owns 322,223 shares of the biopharmaceutical company’s stock worth $31,874,000 after buying an additional 291,293 shares in the last quarter. Toth Financial Advisory Corp bought a new position in shares of Incyte during the 4th quarter worth about $1,213,000. Fairvoy Private Wealth LLC boosted its position in shares of Incyte by 468.8% during the 4th quarter. Fairvoy Private Wealth LLC now owns 30,169 shares of the biopharmaceutical company’s stock valued at $2,980,000 after acquiring an additional 24,865 shares in the last quarter. SG Americas Securities LLC boosted its position in shares of Incyte by 627.8% during the 4th quarter. SG Americas Securities LLC now owns 186,790 shares of the biopharmaceutical company’s stock valued at $18,449,000 after acquiring an additional 161,124 shares in the last quarter. Finally, Universal Beteiligungs und Servicegesellschaft mbH increased its stake in Incyte by 11.5% in the fourth quarter. Universal Beteiligungs und Servicegesellschaft mbH now owns 210,097 shares of the biopharmaceutical company’s stock valued at $20,719,000 after acquiring an additional 21,735 shares during the period. Institutional investors and hedge funds own 96.97% of the company’s stock.
Incyte Stock Down 1.4% Shares of NASDAQ:INCY opened at $115.65 on Tuesday. The company has a quick ratio of 3.60, a current ratio of 3.68 and a debt-to-equity ratio of 0.01. The firm has a market cap of $23.10 billion, a P/E ratio of 16.33, a P/E/G ratio of 1.06 and a beta of 0.76. Incyte Corporation has a 12 month low of $67.17 and a 12 month high of $119.60. The company’s 50-day moving average price is $105.29 and its two-hundred day moving average price is $101.16.
Incyte (NASDAQ:INCY – Get Free Report) last announced its earnings results on Tuesday, April 28th. The biopharmaceutical company reported $1.81 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $1.38 by $0.43. Incyte had a net margin of 26.71% and a return on equity of 26.66%. The company had revenue of $1.27 billion for the quarter, compared to analyst estimates of $1.22 billion. During the same period in the prior year, the business earned $1.16 earnings per share. Incyte’s quarterly revenue was up 20.9% on a year-over-year basis. As a group, research analysts forecast that Incyte Corporation will post 6.61 EPS for the current fiscal year.
Wall Street Analysts Forecast Growth A number of equities research analysts have weighed in on INCY shares. Barclays lifted their price objective on Incyte from $117.00 to $134.00 and gave the company an “overweight” rating in a report on Tuesday, July 14th. Oppenheimer reiterated a “market perform” rating and issued a $107.00 price target on shares of Incyte in a research report on Monday, June 8th. Weiss Ratings reissued a “buy (b-)” rating on shares of Incyte in a report on Monday, June 29th. Sanford C. Bernstein started coverage on shares of Incyte in a report on Thursday, May 21st. They issued a “market perform” rating and a $99.00 target price on the stock. Finally, TD Cowen reissued a “hold” rating on shares of Incyte in a report on Tuesday, June 9th. Eight equities research analysts have rated the stock with a Buy rating and fourteen have issued a Hold rating to the stock. According to MarketBeat, the stock has a consensus rating of “Hold” and a consensus target price of $109.95.
View Our Latest Stock Analysis on Incyte
About Incyte (Free Report)
Incyte Corporation is a Wilmington, Delaware–based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies in oncology and inflammation. Since its founding in 2002, Incyte has grown from a small research organization into a global enterprise, advancing a portfolio of internally developed and partnered assets. The company’s research and development efforts center on small-molecule drugs and biologics that modulate critical signaling pathways implicated in cancer, autoimmune disorders and rare diseases.
The company’s flagship product is Jakafi® (ruxolitinib), a Janus kinase (JAK) inhibitor approved for the treatment of myelofibrosis and polycythemia vera.
Read More Five stocks we like better than Incyte 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 INCY? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Incyte Corporation (NASDAQ:INCY – Free Report).
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Agreement provides Incyte the rights to develop and commercialize ENHANZE® with its mutCALR development program and an option to nominate up to two additional targets
, /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") today announced that it has entered into a global collaboration and license agreement with Incyte (Nasdaq: INCY) to evaluate additional subcutaneous formulations of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs), utilizing Halozyme's proprietary ENHANZE® drug delivery technology. The collaboration will focus on the potential for ENHANZE® to strengthen the subcutaneous formulation currently in development for INCA033989, with the goal of enabling more convenient delivery and dosing regimens that may improve the treatment experience.
Under the terms of the agreement, Halozyme will receive an upfront payment from Incyte and is eligible to receive additional payments upon achievement of agreed upon milestones. In addition, Halozyme is eligible to receive royalties on net sales of commercialized medicines using ENHANZE®. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE®.
"This collaboration with Incyte underscores the continued momentum and broad applicability of our ENHANZE technology across high-value therapeutic areas," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "Incyte brings a strong portfolio and deep expertise in hematology, and we look forward to working together to enable the development of more convenient subcutaneous treatment options for patients. This agreement builds on Halozyme's established track record of successful collaborations with leading biopharmaceutical companies and further diversifies our portfolio of partnered programs across multiple therapeutic areas."
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V., Skye Bioscience and GSK.
Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at‑home and healthcare‑provider settings. The addition of Surf Bio's polymer‑based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon™ and Surf Bio's technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals and Oruka Therapeutics.
Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.
Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.
For more information, visit www.halozyme.com and connect with us on LinkedIn.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning royalty revenue growth, margins and durability, potential new partnerships and innovations, the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE® including facilitating more convenient administration and dosing regimens of injectable medications through subcutaneous delivery and potentially lowering the treatment burden, easing treatment access and improving the treatment experience for patients. These forward-looking statements may also include statements regarding the product development and commercialization efforts of Halozyme's collaboration partner (including the potential advancement, regulatory approval and launch of products as a result of such efforts and the potential nomination of additional targets) and Halozyme's potential receipt of payments associated with achievement of certain milestones, and royalties on sales of commercialized products. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue" and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including risks and uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether additional targets are nominated under the collaboration agreement referred to in this press release and whether collaborative products are ultimately developed, approved or commercialized and the potential future market for such products, unexpected levels of revenue growth, expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
WILMINGTON, Del.--(BUSINESS WIRE)---- $INCY--Incyte Data to Be Highlighted in Four Rapid Oral Presentations at ESMO 2026 Support Efforts to Improve Outcomes in Difficult-to-Treat Cancers.
Incyte (Nasdaq: INCY) today announced complete safety and efficacy data from all patients (n=16) enrolled in the Phase 1/2 multidose study of VGA039 (latarciba
- Treatment with latarcibart led to an 81% median reduction in annualized bleeding rate (ABR) across all bleeding categories and patient types with von Willebrand disease (VWD)
- Latarcibart, administered via a once monthly subcutaneous dosing regimen, was shown to be safe and well tolerated over multiple doses in this study
- Pivotal Phase 3 VIVID-6 trial evaluating latarcibart’s potential to be the first targeted therapy for VWD is currently enrolling
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq: INCY) today announced complete safety and efficacy data from all patients (n=16) enrolled in the Phase 1/2 multidose study of VGA039 (latarcibart), a novel, Protein S-targeting, investigational monoclonal antibody for patients with von Willebrand disease (VWD). The data are being shared in an oral presentation today at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH 2026 Congress) in Paris.
“These results continue to build a highly consistent body of evidence supporting latarcibart as a significant potential treatment advancement for patients with VWD,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of R&D.
Share Latarcibart modulates Protein S to improve hemostasis, potentially enhancing the body’s ability to prevent or reduce the frequency of bleeding episodes. Latarcibart is in pivotal Phase 3 development for patients with VWD, the most common inherited bleeding disorder. If approved, latarcibart has the potential to be the first, once monthly subcutaneous prophylactic therapy for patients with VWD, offering an important alternative to the frequent intravenous infusions of replacement factor concentrates commonly used in the prophylactic setting today. Given its novel mechanism, latarcibart may also have potential in other bleeding disorders.
“These results continue to build a highly consistent body of evidence supporting latarcibart as a significant potential treatment advancement for patients with VWD,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “This multidose dataset underscores the potential of latarcibart to address the longstanding need for a prophylactic therapy that provides meaningful protection for patients with all types of VWD. We are continuing to enroll the Phase 3 VIVID-6 study as we work toward redefining the standard of routine prophylactic care for patients with VWD.”
As of May 5, 2026, data from all 16 patients enrolled in the Phase 1/2 multidose study were available, and all participants had completed the multidose regimen of six doses of latarcibart, with maintenance doses administered subcutaneously every four weeks. Key data highlights include:
Substantial reductions in ABR (annualized bleeding rate) were seen across study patients, including all VWD types and bleed types, such as serious GI and hemophilia-like joint and muscle bleeds. The median ABR reduction across all VWD types and bleed categories was 81%. In patients switching from prior von Willebrand factor (VWF)-containing prophylaxis (IV infusions multiple times per week), bleed reductions were 75-100%, indicating potential improvement over current standard of care. Among patients not previously receiving IV prophylaxis, 7 had historical ABRs >12, a key eligibility criterion for the Phase 3 VIVID-6 study. In this group, ABR reductions ranged from 46-100%, with nearly all patients (6/7) achieving reductions >73%. Latarcibart treatment resulted in ~86% reduction in VWF-treated breakthrough bleeds, with 70% of patients with prior VWF-treated bleeds not experiencing a VWF-treated breakthrough bleed while on treatment. All participants who entered the study with a substantial bleed burden transitioned to continue receiving latarcibart in the ongoing open-label extension study. Latarcibart once monthly subcutaneous prophylaxis was safe and well tolerated over multiple doses. Three treatment-emergent adverse events (TEAEs) related to latarcibart were reported: two Grade 2 headaches in one patient and one report of Grade 1 injection site reactions. There was also one unrelated serious adverse event of severe gastrointestinal (GI) bleeding in a patient with a history of frequent and severe GI bleeding. “Many people with VWD struggle with bleeding and need more effective and convenient prophylactic treatments. The study results showed treatment with latarcibart delivered consistent and clinically meaningful reductions in bleeding across a diverse group of VWD patients, including patients with all major types of the disease and individuals transitioning from intensive IV prophylaxis,” said Allison Wheeler, M.D., MSCI, Associate Professor of Pediatrics at the University of Washington. “Equally important, the favorable safety profile and once monthly subcutaneous dosing regimen have the potential to substantially reduce treatment burden while providing consistent bleed protection. Together, these findings provide a strong foundation for the Phase 3 study and support latarcibart’s potential as an important new treatment option for patients with VWD.”
More information regarding the ISTH 2026 Congress can be found on the ISTH website: https://www.isthcongress.org/ (Session details: Novel Therapies for Bleeding Disorders, Including VWD and Rare Bleeding Disorders – 2; Publication Number: OC 32.3).
About VGA039 (latarcibart)
VGA039 (latarcibart) is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. Latarcibart has the potential to be a universal prophylactic therapy for numerous bleeding disorders, starting with all types of von Willebrand disease (VWD) and bleeding sites. As a subcutaneously self-administered investigational antibody therapy with a once monthly dosing regimen, latarcibart has the potential to improve bleeding outcomes, convenience, and quality of life for patients.
Latarcibart has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). Latarcibart has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of latarcibart as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.
Incyte acquired VGA039 (latarcibart) in July 2026 as part of its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics LLC.
About the VIVID Clinical Program
The VIVID multinational clinical program consists of multiple clinical trials, from Phase 1 to 3, in both a platform multi-phase protocol (VIVID-1-5) and a standalone Phase 3 protocol (VIVID-6) evaluating the safety and efficacy of VGA039 in VWD. The VIVID clinical program is active across 6 continents and designed to support future registrational filings globally.
About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). People with VWD may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the data to be presented by Incyte at the ISTH 2026 Congress; Incyte’s expectations regarding VGA039’s (latarcibart’s) clinical development and regulatory approvals; the potential and promise latarcibart offers patients with bleeding disorders, including the potential to be the first once monthly subcutaneous prophylactic therapy for patients with VWD, its potential improvement over current standards of care for patients with VWD and other bleeding disorders, and its potential ability to address significant unmet need, reduce treatment burden and improve quality of life; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including results from clinical trials of and the sufficiency of clinical trial data for latarcibart, as well as Incyte’s other products and product candidates, to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for latarcibart, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Incyte (INCY 0.67%) and TG Therapeutics (TGTX 1.43%) are commercial-stage biotech companies that are using blockbuster drugs to fund the growth of their promising pipelines. Incyte is known for its work in Janus kinase (JAK) inhibition, focusing on dermatology, oncology, hematology, inflammation, and autoimmune disorders.TG Therapeutics is focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases.
Both stocks are delivering strong returns. Shares of Incyte are up more than 17% this year, while TG Therapeutics is up nearly 90% so far in 2026.
Here are reasons to buy the pharmaceutical stocks:
Image source: Getty Images.
Incyte has strong cash flow and operational beats Incyte's financial health is anchored by its blockbuster JAK inhibitor, Jakafi, for rare blood cancers, and its fast-growing dermatology cream, Opzelura, approved to treat vitiligo and eczema.
In the first quarter, Incyte reported Jakafi sales of $758 million, up 7% year over year, and Opzelura had sales of $143 million, up 20% over the same period last year. Overall revenue was $1.27 billion, up 21% year over year, and earnings per share (EPS) were $1.47, up 83.7% over the first quarter of 2025. Adjusted EPS was $1.81, beating the analysts' consensus of $1.34.
The growing diversification of its pipeline Incyte is aggressively using its free cash flow to buy its way out of concentration risk. A prime example is its recent $1.25 billion acquisition of Vega Therapeutics, which gives it a highly promising phase 3 subcutaneous bleeding disorder asset (VGA039). This expands its footprint into hematology outside of cancer, padding its late-stage pipeline with potential first-in-class multibillion-dollar drugs.
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CEO Bill Meury said Incyte has 10 phase 3 studies underway and anticipates four new approvals and launches in cancer and immunology through early 2027. One key late-stage pipeline therapy is Monjuvi, which performed well as a combination therapy in a phase 3 trial as a first-line treatment for diffuse large B-cell lymphoma (DLBCL).
Another is povorcitinib to treat the skin conditions hidradenitis suppurativa and nonsegmental vitiligo. The company also has high hopes for INCB161734 as a treatment for pancreatic ductal adenocarcinoma.
Highly efficient financial metrics For a biotech, Incyte demonstrates remarkable capital efficiency. It has an exceptional return on equity of more than 30%, reflecting a management team that is proficient at turning shareholder investments and cash reserves into real, tangible earnings.
TG Therapeutics is riding Briumvi momentum Briumvi, TG Therapeutics' IV infusion for the treatment of relapsing forms of multiple sclerosis (MS), is driving growth. Management recently raised its full-year revenue guidance to $925 million after the drug brought in $194.8 million in first-quarter U.S. sales alone. The company also raised full-year Briumi guidance to $885 million to $900 million in sales.
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The drug is in a phase 3 trial as an at-home self-administered subcutaneous injection format to treat MS. It is also being examined for treatment-resistant schizophrenia in patients who do not fully respond to standard antipsychotics, as well as a subcutaneous form to treat Myasthenia Gravis, a chronic, rare autoimmune neuromuscular disorder.
It has an attractive acquisition profile TG Therapeutics has a powerhouse gross-margin profile sitting around 83%. In the first quarter, the company reported revenue of $204.9 million, up 69.5%, year over year. EPS was $0.12, up 300% over the same period a year ago.
Given the recent wave of multibillion-dollar merger and acquisition deals sweeping the biotech sector, the company's highly profitable, single-blockbuster commercial engine makes it a prime, highly lucrative takeover target for a pharmaceutical giant looking to buy a turnkey neurology franchise.
Potential suitors include large pharmaceutical companies with an existing footprint in neurology and immunology, such as Sanofi, which has a history of big MS drugs such as Aubagio and Lemtrada; Novartis, the maker of competing MS drugs Kesimpta and Gilenya; and Biogen, a dominant player in the MS space.
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, July 28, 2026. The schedule for the press release and conference call/webcast is as follows: Q2 2026 Press Release: July 28, 2026, at 7:00 a.m. ET Q2 2026 Conference Call: July 28, 2026, at 8:00 a.m. ET Domestic Dial-In Number: 877-407-3042 International Dial-In Number: 201-389-0864 Conference ID Number: 13759.
WILMINGTON, Del.--(BUSINESS WIRE)---- $INCY--Incyte Completes Acquisition of Vega Therapeutics, a Wholly Owned Subsidiary of Star Therapeutics, Expanding its Hematology Portfolio.
Three outlier inflow signals push biopharmaceutical firm Incyte Corporation (INCY) up 71% in a year.
INCY discovers, develops, and sells proprietary therapeutics focused on hematology, oncology, inflammation, and autoimmunity. The company’s first-quarter fiscal 2026 earnings report, INCY showed $1.27 billion in quarterly revenue (a 21% year-over-year gain) led by Jakafi ($758 million) and Opzelura ($143 million), net sales of $1.1 billion (a 20% rise), and offered annual net sales guidance of up to $4.94 billion, representing a 13% jump from the prior year. To expand its hematology business, the company also recently acquired a therapeutics firm focused on bleeding disorders.
It’s no wonder INCY shares are up 15% this year, and they could rise more. MoneyFlows data shows how Big Money investors are again betting heavily on the stock.
Institutions Buying Incyte Institutional volumes reveal plenty. In the last year, INCY has endured some choppiness. But it’s once again enjoying strong investor demand, which we believe to be institutional support.
Each green bar signals unusually large volumes in INCY shares. They reflect our proprietary inflow signal, pushing the stock higher:
Source: www.moneyflows.com Plenty of health care names are under accumulation right now. But there’s a powerful fundamental story happening with Incyte.
Incyte Fundamental Analysis Institutional support and a healthy fundamental backdrop make this company worth investigating. As you can see, INCY has had strong sales and earnings growth:
Also, EPS is estimated to ramp higher this year by +16.3%.
Now it makes sense why the stock has been generating Big Money interest. INCY has a track record of strong financial performance.
Marrying great fundamentals with MoneyFlows software has found some big winning stocks over the long term.
Incyte has been a top-rated stock at MoneyFlows for years. That means the stock has unusual buy pressure and growing fundamentals. We have a ranking process that showcases stocks like this on a weekly basis.
In the last year, INCY has drawn three outlier inflow signals and is up 70.7%. The blue bars below show when INCY was a top pick on the Outlier 20 report…Big Money support matters:
Source: www.moneyflows.com Tracking unusual volumes reveals the power of money flows.
This is a trait that most outlier stocks exhibit…the best of the best. Big Money demand drives stocks upward.
Incyte Price Prediction The INCY action isn’t new at all. Big Money buying in the shares is signaling to take notice. Given the historical gains in share price and strong fundamentals, this stock could be worth a spot in a diversified portfolio.
Disclosure: the author holds no position in INCY at the time of publication.
If you are a Registered Investment Advisor (RIA) or are a serious investor, take your investing to the next level and follow our free weekly MoneyFlows insights.
Incyte (INCY) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.
Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in INCY over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.
Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positi
MORGES, Switzerland--(BUSINESS WIRE)---- $INCY--Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis.
Key Takeaways MIRM/INCY reported positive phase II data showing zilurgisertib's efficacy in FOP patients.The investigational therapy reduced the proportion of patients with new HO lesions by 81% versus placebo.MIRM and INCY's zilurgisertib NDA received FDA Priority Review, with a decision due by Sept. 26, 2026. Mirum Pharmaceuticals (MIRM - Free Report) and Incyte Corporation (INCY - Free Report) have reported positive pivotal phase II results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral ALK2 inhibitor, in adolescent and adult patients with fibrodysplasia ossificans progressiva (FOP). The data showed that the investigational oral therapy reduced the proportion of patients with new heterotopic ossification (HO) lesions. Improvements were observed across key secondary endpoints, including lesion volume measures and reductions in disease flare activity, reflecting zilurgisertib’s potential as a new treatment option for the ultra-rare disease.
FOP is a rare genetic disorder in which muscle, tendons and other soft tissues progressively transform into bone, causing irreversible loss of mobility and severe disability over time. Based on the positive pivotal study findings, the FDA has accepted the new drug application (NDA) for zilurgisertib for FOP and granted Priority Review status. The agency is expected to deliver its decision regarding the NDA by Sept. 26, 2026.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions. Mirum licensed worldwide development and commercialization rights to the candidate from Incyte.
Year to date, MIRM and INCY’s shares have risen 28.5% and 1%, respectively, against the industry’s 1.4% decline.
Image Source: Zacks Investment Research
MIRM/INCY's Pivotal Phase II FOP Study Data in DetailsThe pivotal phase II PROGRESS study is evaluating the safety and efficacy of zilurgisertib in FOP patients. Cohort 1 enrolled 63 patients aged 12 years and older, who were randomized equally to receive either zilurgisertib 100 mg once daily or placebo for 24 weeks, followed by an open-label extension period. At the time of analysis, 61 patients had available 48-week whole-body CT scan data.
The primary endpoint assessed the proportion of patients developing new HO lesions at Week 24. Results showed that only one patient (3.1%) in the zilurgisertib arm developed a new lesion compared with five patients (16.7%) in the placebo group, representing an 81% reduction. The treatment demonstrated consistent benefits across several secondary efficacy measures.
Mirum and Incyte reported particularly strong effects on new lesion burden. Patients receiving zilurgisertib experienced a 99.9% reduction in the total volume of newly formed HO lesions compared with placebo at Week 24. The mean volume of new lesions was nearly eliminated in the treatment arm, highlighting the drug's ability to suppress abnormal bone formation. Treated patients also developed fewer new lesions overall compared with placebo recipients.
The study also showed favorable effects on overall disease burden. Patients receiving zilurgisertib experienced a reduction in total HO lesion volume by Week 24, whereas total lesion volume increased among placebo-treated patients. Annualized flare activity was likewise lower in the treatment arm, with patients receiving zilurgisertib reporting fewer new disease flares than those receiving placebo.
Results from the open-label extension demonstrated sustained benefit through Week 48. No new HO lesions were observed among patients who continued receiving zilurgisertib, and no new lesions were reported in patients who crossed over from placebo to active treatment after Week 24. Total HO lesion volume continued to decline in both groups through Week 48, while flare activity remained low over the extended treatment period.
The safety profile remained favorable throughout the placebo-controlled portion of the study. Most adverse events were mild to moderate in severity, and no patients discontinued treatment or required dose reductions because of adverse events.
With positive pivotal data now in hand and Priority Review underway, Mirum and Incyte are moving closer to potentially bringing zilurgisertib to patients with FOP, a population with limited treatment options and significant unmet medical need.
MIRM/INCY’s Zacks Rank and Stocks to ConsiderMirum and Incyte currently carry a Zacks Rank #3 (Hold) each.
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 97.2% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 18.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
(We are reissuing this article to correct a mistake. The previous article, issued on June 16, 2026, should no longer be relied upon.)
WILMINGTON, Del.--(BUSINESS WIRE)---- $INCY--Incyte Japan Announces Approval of Minjuvi (tafasitamab) in Combination with Lenalidomide for Adults with Relapsed or Refractory DLBCL.
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Stock to Watch: Incyte (INCY - Free Report) Wilmington, Delaware based Incyte Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. The company conducts its European clinical development operations in Geneva, Switzerland.
INCY is a #3 (Hold) on the Zacks Rank, with a VGM Score of A.
Momentum investors should take note of this Medical stock. INCY has a Momentum Style Score of A, and shares are up 0.8% over the past four weeks.
Eight analysts revised their earnings estimate upwards in the last 60 days for fiscal 2026. The Zacks Consensus Estimate has increased $0.09 to $7.67 per share. INCY boasts an average earnings surprise of +18.3%.
With a solid Zacks Rank and top-tier Momentum and VGM Style Scores, INCY should be on investors' short list.
Key Takeaways MIRM/INCY reported positive phase II data showing zilurgisertib's efficacy in FOP patients.The investigational therapy reduced new HO lesion formation by 81% versus placebo and met key secondary goals.MIRM and INCY's zilurgisertib NDA received FDA Priority Review, with a decision due by Sept. 26, 2026. Mirum Pharmaceuticals (MIRM - Free Report) and Incyte Corporation (INCY - Free Report) have reported positive pivotal phase II results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral ALK2 inhibitor, in adolescent and adult patients with fibrodysplasia ossificans progressiva (FOP). The data showed that the investigational oral therapy significantly reduced new heterotopic ossification (HO) lesion formation. Key secondary endpoints, including lesion volume measures and disease flare activity, were met, which reflected zilurgisertib’s potential as a new treatment option for the ultra-rare disease.
FOP is a rare genetic disorder in which muscle, tendons and other soft tissues progressively transform into bone, causing irreversible loss of mobility and severe disability over time. Based on the positive pivotal study findings, the FDA has accepted the new drug application (NDA) for zilurgisertib for FOP and granted Priority Review status. The agency is expected to deliver its decision regarding the NDA by Sept. 26, 2026.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions. Mirum licensed worldwide development and commercialization rights to the candidate from Incyte.
Year to date, MIRM and INCY’s shares have risen 25.7% and 9.9%, respectively, against the industry’s 1.4% decline.
Image Source: Zacks Investment Research
MIRM/INCY's Pivotal Phase II FOP Study Data in DetailsThe pivotal phase II PROGRESS study is evaluating the safety and efficacy of zilurgisertib in FOP patients. Cohort 1 enrolled 63 patients aged 12 years and older, who were randomized equally to receive either zilurgisertib 100 mg once daily or placebo for 24 weeks, followed by an open-label extension period. At the time of analysis, 61 patients had available 48-week whole-body CT scan data.
The primary endpoint assessed the proportion of patients developing new HO lesions at Week 24. Results showed that only one patient (3.1%) in the zilurgisertib arm developed a new lesion compared with five patients (16.7%) in the placebo group, representing an 81% reduction. The treatment demonstrated consistent benefits across several secondary efficacy measures.
Mirum and Incyte reported particularly strong effects on new lesion burden. Patients receiving zilurgisertib experienced a 99.9% reduction in the total volume of newly formed HO lesions compared with placebo at Week 24. The mean volume of new lesions was nearly eliminated in the treatment arm, highlighting the drug's ability to suppress abnormal bone formation. Treated patients also developed fewer new lesions overall compared with placebo recipients.
The study also showed favorable effects on overall disease burden. Patients receiving zilurgisertib experienced a reduction in total HO lesion volume by Week 24, whereas total lesion volume increased among placebo-treated patients. Annualized flare activity was likewise lower in the treatment arm, with patients receiving zilurgisertib reporting fewer new disease flares than those receiving placebo.
Results from the open-label extension demonstrated sustained benefit through Week 48. No new HO lesions were observed among patients who continued receiving zilurgisertib, and no new lesions were reported in patients who crossed over from placebo to active treatment after Week 24. Total HO lesion volume continued to decline in both groups through Week 48, while flare activity remained low over the extended treatment period.
The safety profile remained favorable throughout the placebo-controlled portion of the study. Most adverse events were mild to moderate in severity, and no patients discontinued treatment or required dose reductions because of adverse events.
With positive pivotal data now in hand and Priority Review underway, Mirum and Incyte are moving closer to potentially bringing zilurgisertib to patients with FOP, a population with limited treatment options and significant unmet medical need.
MIRM/INCY’s Zacks Rank and Stocks to ConsiderMirum and Incyte currently carry a Zacks Rank #3 (Hold) each.
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 106.7% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 16.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
(We are reissuing this article to correct a mistake. The original article, issued on June 15, 2026, should no longer be relied upon.)
Key Takeaways MIRM/INCY reported positive phase II data showing zilurgisertib met the primary endpoint in FOP patients.The investigational therapy reduced new HO lesion formation by 81% versus placebo and met key secondary goals.MIRM and INCY's zilurgisertib NDA received FDA Priority Review, with a decision due by Sept. 26, 2026. Mirum Pharmaceuticals (MIRM - Free Report) and Incyte Corporation (INCY - Free Report) have reported positive pivotal phase II results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral ALK2 inhibitor, in adolescent and adult patients with fibrodysplasia ossificans progressiva (FOP). The data showed that the investigational oral therapy significantly reduced new heterotopic ossification (HO) lesion formation, meeting the study’s primary endpoint. Key secondary endpoints, including lesion volume measures and disease flare activity, were also met, supporting zilurgisertib’s potential as a new treatment option for the ultra-rare disease.
FOP is a rare genetic disorder in which muscle, tendons and other soft tissues progressively transform into bone, causing irreversible loss of mobility and severe disability over time. Based on the positive pivotal study findings, the FDA has accepted the new drug application (NDA) for zilurgisertib for FOP and granted Priority Review status. The agency is expected to deliver its decision regarding the NDA by Sept. 26, 2026.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions. Mirum licensed worldwide development and commercialization rights to the candidate from Incyte.
Year to date, MIRM and INCY’s shares have risen 25.7% and 9.9%, respectively, against the industry’s 1.4% decline.
Image Source: Zacks Investment Research
MIRM/INCY's Pivotal Phase II FOP Study Data in DetailsThe pivotal phase II PROGRESS study is evaluating the safety and efficacy of zilurgisertib in FOP patients. Cohort 1 enrolled 63 patients aged 12 years and older, who were randomized equally to receive either zilurgisertib 100 mg once daily or placebo for 24 weeks, followed by an open-label extension period. At the time of analysis, 61 patients had available 48-week whole-body CT scan data.
The primary endpoint assessed the proportion of patients developing new HO lesions at Week 24. Results showed that only one patient (3.1%) in the zilurgisertib arm developed a new lesion compared with five patients (16.7%) in the placebo group, representing an 81% reduction. The treatment demonstrated consistent benefits across several secondary efficacy measures.
Mirum and Incyte reported particularly strong effects on new lesion burden. Patients receiving zilurgisertib experienced a 99.9% reduction in the total volume of newly formed HO lesions compared with placebo at Week 24. The mean volume of new lesions was nearly eliminated in the treatment arm, highlighting the drug's ability to suppress abnormal bone formation. Treated patients also developed fewer new lesions overall compared with placebo recipients.
The study also showed favorable effects on overall disease burden. Patients receiving zilurgisertib experienced a reduction in total HO lesion volume by Week 24, whereas total lesion volume increased among placebo-treated patients. Annualized flare activity was likewise lower in the treatment arm, with patients receiving zilurgisertib reporting fewer new disease flares than those receiving placebo.
Results from the open-label extension demonstrated sustained benefit through Week 48. No new HO lesions were observed among patients who continued receiving zilurgisertib, and no new lesions were reported in patients who crossed over from placebo to active treatment after Week 24. Total HO lesion volume continued to decline in both groups through Week 48, while flare activity remained low over the extended treatment period.
The safety profile remained favorable throughout the placebo-controlled portion of the study. Most adverse events were mild to moderate in severity, and no patients discontinued treatment or required dose reductions because of adverse events.
With positive pivotal data now in hand and Priority Review underway, Mirum and Incyte are moving closer to potentially bringing zilurgisertib to patients with FOP, a population with limited treatment options and significant unmet medical need.
MIRM/INCY’s Zacks Rank and Stocks to ConsiderMirum and Incyte currently carry a Zacks Rank #3 (Hold) each.
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 106.7% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 16.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced pivotal Phase 2 results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral activin receptor-like kinase 2 (ALK2) inhibitor, in adolescents and adults (≥12 years of age) with fibrodysplasia ossificans progressiva (FOP). Results were shared in a late-breaking rapid-fire presentation at ENDO 2026, the Endocrine Society’s annual meeting.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260614539468/en/
Results from Cohort 1 of the PROGRESS study demonstrated a consistent treatment effect across measures of disease activity and durability through Week 48. During the open-label extension, no new HO lesions were observed among patients who continued to receive zilurgisertib or among placebo-treated patients who crossed over to active treatment at Week 24.
"The findings presented at ENDO represent an important milestone for the zilurgisertib program and further strengthen the growing body of clinical evidence supporting its potential as a treatment for FOP," said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-Stage Development at Incyte.
"People living with FOP and their families urgently need additional treatment options," said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. "These results reinforce our confidence in the potential of zilurgisertib and our commitment to working with Incyte to bring this important program forward as we prepare for potential commercialization and support the FOP community."
Cohort 1 of the PROGRESS study evaluated zilurgisertib 100 mg once-daily in 63 adolescents and adults (≥12 years of age) with FOP. Patients were randomized 1:1 to receive zilurgisertib (n=32) or placebo (n=31) during a 24-week, placebo-controlled, double-blind period, followed by an open-label extension period. Baseline demographics and disease characteristics were generally balanced between treatment groups, with a mean age of approximately 21 years and evidence of recent disease activity prior to enrollment. A total of 61 patients had 48-week whole-body CT scan data available at the time of the open-label extension analysis.
Key efficacy findings included:
Fewer patients receiving zilurgisertib developed new HO lesions at Week 24, with an 81% reduction versus placebo (p=0.0986). 99.9% reduction in total volume of new HO lesions in patients receiving zilurgisertib versus placebo at Week 24 (nominal p-value<0.0001). Reduction in total existing HO lesion volume compared with an increase observed in placebo-treated patients at Week 24 (nominal p-value=0.004). Among patients receiving zilurgisertib, no new HO lesions were observed and total HO lesion volume continued to decrease from Week 24 to Week 48. Among patients who crossed over from placebo to zilurgisertib, no new HO lesions were observed and total HO lesion volume decreased from Week 24 to Week 48. Key Efficacy Findings (Week 24 Placebo-Controlled Period and Week 48 Crossover)
Endpoint
Zilurgisertib (ZGB)
(n=32)
Week 24
Placebo
(n=31)
Week 24
Key Finding
Open-Label Extension
Week 48
Number (%) of patients who developed new HO lesions
1 (3.1)
5 (16.7)
81% reduction vs placebo
No patients with new HO lesions observed at Week 48 (n=61)
Zilurgisertib was generally well-tolerated during the 24-week placebo-controlled period of the study. Data showed:
Most adverse events were mild or moderate in severity. No adverse events led to treatment discontinuation or dose reduction. Serious adverse events and Grade ≥3 adverse events occurred at low rates in both treatment groups. The most commonly reported adverse events among patients receiving zilurgisertib were FOP flare-up or aching/pain due to FOP (25%), headache (21.9%), upper respiratory tract infection (21.9%), arthralgia (18.8%), epistaxis (12.5%), and nausea (12.5%). The full abstract is available on the Endocrine Society’s ENDO 2026 website. Detailed analyses are also posted on the Publications & Presentations section of Mirum’s website.
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for zilurgisertib for the treatment of FOP in patients 12 years of age and older and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date for zilurgisertib is September 26, 2026.
About Zilurgisertib
Zilurgisertib is an investigational, oral, small molecule, activin receptor-like kinase 2 (ALK2) inhibitor in development for the treatment of Fibrodysplasia Ossificans Progressiva (FOP). Zilurgisertib is designed to inhibit the ALK2 receptor, which is abnormally active in most patients with FOP and leads to bone formation in soft tissues, a process known as heterotopic ossification (HO). FOP is an ultra-rare genetic disease that affects approximately 300 patients in the U.S. and 900 worldwide, with diagnosis typically occurring in early childhood. Zilurgisertib was evaluated in the PROGRESS pivotal Phase 2 study, which formed the basis of a new drug application (NDA). The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.
Mirum Pharmaceuticals, Inc. licensed zilurgisertib from Incyte for worldwide development and commercialization.
About the PROGRESS Study
PROGRESS is a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of zilurgisertib in patients with fibrodysplasia ossificans progressiva (FOP). PROGRESS Cohort 1 enrolled patients 12 years of age and older who were randomized 1:1 to receive zilurgisertib 100 mg once daily or placebo during a 24-week double-blind treatment period, followed by an open-label extension. Additional PROGRESS cohorts will evaluate the efficacy and safety of zilurgisertib in patients ages 6 to <12 years of age (Cohort 2) and in patients ages 2 to <12 years of age (Cohort 3).
The primary endpoint of the study is the proportion of Cohort 1 patients with new heterotopic ossification (HO) lesions at Week 24 as assessed by whole-body CT scan data. Key secondary endpoints include the number and total volume of new HO lesions, changes in total HO lesion volume and flare activity through Week 24.
About Mirum Pharmaceuticals
Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX).
Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS).
Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Mirum Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company’s planned participation at a scientific congress, Mirum’s continued advancement of zilurgisertib with Incyte, the likelihood of a FDA approval pathway for zilurgisertib and the potential benefit of zilurgisertib in real world settings versus scientific presentations of data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the presentation of data from the PROGRESS study; the potential for zilurgisertib to become a treatment option for people living with FOP; expectations regarding ongoing and future clinical trials for zilurgisertib, including the timing of such trials; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s and its partners’ products; the ability of Incyte and its partners to achieve commercial success for their marketed products and product candidates, if approved; Incyte’s and its partners’ ability to obtain and maintain protection of intellectual property for their products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s and its partners’ products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Mirum and the Mirum logo are trademarks of Mirum Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260614539468/en/
FOSTER CITY, Calif. & WILMINGTON, Del.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced pivotal Phase 2 results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral activin receptor-like kinase 2 (ALK2) inhibitor, in adolescents and adults (≥12 years of age) with fibrodysplasia ossificans progressiva (FOP). Results were shared in a late-breaking rapid-fire presentation at ENDO 2026, the Endocrine Society’s annual meeting.
Results from Cohort 1 of the PROGRESS study demonstrated a consistent treatment effect across measures of disease activity and durability through Week 48. During the open-label extension, no new HO lesions were observed among patients who continued to receive zilurgisertib or among placebo-treated patients who crossed over to active treatment at Week 24.
"The findings presented at ENDO represent an important milestone for the zilurgisertib program and further strengthen the growing body of clinical evidence supporting its potential as a treatment for FOP," said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-Stage Development at Incyte.
"People living with FOP and their families urgently need additional treatment options," said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. "These results reinforce our confidence in the potential of zilurgisertib and our commitment to working with Incyte to bring this important program forward as we prepare for potential commercialization and support the FOP community."
Cohort 1 of the PROGRESS study evaluated zilurgisertib 100 mg once-daily in 63 adolescents and adults (≥12 years of age) with FOP. Patients were randomized 1:1 to receive zilurgisertib (n=32) or placebo (n=31) during a 24-week, placebo-controlled, double-blind period, followed by an open-label extension period. Baseline demographics and disease characteristics were generally balanced between treatment groups, with a mean age of approximately 21 years and evidence of recent disease activity prior to enrollment. A total of 61 patients had 48-week whole-body CT scan data available at the time of the open-label extension analysis.
Key efficacy findings included:
Fewer patients receiving zilurgisertib developed new HO lesions at Week 24, with an 81% reduction versus placebo (p=0.0986). 99.9% reduction in total volume of new HO lesions in patients receiving zilurgisertib versus placebo at Week 24 (nominal p-value<0.0001). Reduction in total existing HO lesion volume compared with an increase observed in placebo-treated patients at Week 24 (nominal p-value=0.004). Among patients receiving zilurgisertib, no new HO lesions were observed and total HO lesion volume continued to decrease from Week 24 to Week 48. Among patients who crossed over from placebo to zilurgisertib, no new HO lesions were observed and total HO lesion volume decreased from Week 24 to Week 48. Key Efficacy Findings (Week 24 Placebo-Controlled Period and Week 48 Crossover)
Endpoint
Zilurgisertib (ZGB)
(n=32)
Week 24
Placebo
(n=31)
Week 24
Key Finding
Open-Label Extension
Week 48
Number (%) of patients who developed new HO lesions
1 (3.1)
5 (16.7)
81% reduction vs placebo
No patients with new HO lesions observed at Week 48 (n=61)
Zilurgisertib was generally well-tolerated during the 24-week placebo-controlled period of the study. Data showed:
Most adverse events were mild or moderate in severity. No adverse events led to treatment discontinuation or dose reduction. Serious adverse events and Grade ≥3 adverse events occurred at low rates in both treatment groups. The most commonly reported adverse events among patients receiving zilurgisertib were FOP flare-up or aching/pain due to FOP (25%), headache (21.9%), upper respiratory tract infection (21.9%), arthralgia (18.8%), epistaxis (12.5%), and nausea (12.5%). The full abstract is available on the Endocrine Society’s ENDO 2026 website. Detailed analyses are also posted on the Publications & Presentations section of Mirum’s website.
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for zilurgisertib for the treatment of FOP in patients 12 years of age and older and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date for zilurgisertib is September 26, 2026.
About Zilurgisertib
Zilurgisertib is an investigational, oral, small molecule, activin receptor-like kinase 2 (ALK2) inhibitor in development for the treatment of Fibrodysplasia Ossificans Progressiva (FOP). Zilurgisertib is designed to inhibit the ALK2 receptor, which is abnormally active in most patients with FOP and leads to bone formation in soft tissues, a process known as heterotopic ossification (HO). FOP is an ultra-rare genetic disease that affects approximately 300 patients in the U.S. and 900 worldwide, with diagnosis typically occurring in early childhood. Zilurgisertib was evaluated in the PROGRESS pivotal Phase 2 study, which formed the basis of a new drug application (NDA). The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.
Mirum Pharmaceuticals, Inc. licensed zilurgisertib from Incyte for worldwide development and commercialization.
About the PROGRESS Study
PROGRESS is a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of zilurgisertib in patients with fibrodysplasia ossificans progressiva (FOP). PROGRESS Cohort 1 enrolled patients 12 years of age and older who were randomized 1:1 to receive zilurgisertib 100 mg once daily or placebo during a 24-week double-blind treatment period, followed by an open-label extension. Additional PROGRESS cohorts will evaluate the efficacy and safety of zilurgisertib in patients ages 6 to <12 years of age (Cohort 2) and in patients ages 2 to <12 years of age (Cohort 3).
The primary endpoint of the study is the proportion of Cohort 1 patients with new heterotopic ossification (HO) lesions at Week 24 as assessed by whole-body CT scan data. Key secondary endpoints include the number and total volume of new HO lesions, changes in total HO lesion volume and flare activity through Week 24.
About Mirum Pharmaceuticals
Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX).
Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS).
Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Mirum Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company’s planned participation at a scientific congress, Mirum’s continued advancement of zilurgisertib with Incyte, the likelihood of a FDA approval pathway for zilurgisertib and the potential benefit of zilurgisertib in real world settings versus scientific presentations of data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the presentation of data from the PROGRESS study; the potential for zilurgisertib to become a treatment option for people living with FOP; expectations regarding ongoing and future clinical trials for zilurgisertib, including the timing of such trials; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s and its partners’ products; the ability of Incyte and its partners to achieve commercial success for their marketed products and product candidates, if approved; Incyte’s and its partners’ ability to obtain and maintain protection of intellectual property for their products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s and its partners’ products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Mirum and the Mirum logo are trademarks of Mirum Pharmaceuticals, Inc.
More News From Mirum Pharmaceuticals, Inc. and Incyte
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced updated clinical data from two Phase 1 studies evaluating the safety, tolerability and efficacy of INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). INCA033989 demonstrated rapid, clinically meaningful responses and consistent molecular activity across both myelofibrosis (MF) and essential thrombocythemia (ET), with convergent evidence supporting the potential for disease modification.
“The data presented at EHA 2026 demonstrate clinically meaningful and consistent responses with INCA033989 across both myelofibrosis and essential thrombocythemia,” said Pablo J. Cagnoni, M.D., President of Incyte and Global Head of R&D at Incyte.
Share These findings are being presented in oral and poster presentations at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden (Session: Myeloproliferative neoplasms – Clinical, Presentation numbers: S216, PS1983, PF884).
“The data presented at EHA 2026 demonstrate clinically meaningful and consistent responses with INCA033989 across both myelofibrosis and essential thrombocythemia,” said Pablo J. Cagnoni, M.D., President of Incyte and Global Head of Research and Development. “What distinguishes INCA033989 is its potential to deliver disease control while targeting the biology that drives it. We remain on track to initiate our pivotal ET study by mid-2026 and are actively engaging regulators on a pivotal MF program.”
Results in Patients with Myelofibrosis (MF)
The safety, tolerability, and efficacy of INCA033989 in Type 1 and non-Type 1 patients with MF harboring a CALR mutation is being evaluated in two ongoing Phase 1 studies. Results demonstrate that INCA033989 delivers broad, clinically meaningful improvements across spleen volume, symptom burden and anemia in patients with MF. As a monotherapy and in combination with ruxolitinib, INCA033989 had a manageable safety profile and the majority of patients remained on treatment – no dose-limiting toxicities were observed, and a maximum tolerated dose was not reached.
Monotherapy: INCA033989 was evaluated as monotherapy in patients who were resistant, refractory or intolerant to JAK inhibitor treatment after >12 weeks (JAK R/R/I), or ineligible to JAK inhibitor therapy. The dose escalation cohort evaluated INCA033989 from 24-3500 mg, and the dose expansion cohort evaluated 250 mg and 2000 mg.
INCA033989 monotherapy demonstrated durable clinical benefit, with clinically meaningful improvements across spleen volume, symptoms and anemia across both JAK R/R/I and JAK ineligible patients.
Spleen Volume Reduction (SVR): Rapid and robust spleen volume reductions were observed in patients, with 55% (38/69) and 39% (27/69) of patients achieving the best SVR25 and SVR35 reduction, respectively. At Week 24, 27% (17/62) patients achieved SVR35, including 47% (8/17) JAK ineligible and 20% (9/45) JAK R/R/I. Robust responses were observed in JAK ineligible patients regardless of mutation type (60% [6/10] Type-1 vs. 29% [2/7] non-Type 1). In JAK R/R/I patients, clinically meaningful reductions were observed in 31% (8/26) of Type-1 patients across all evaluated doses at Week 24, and 33% (1/3) of non-Type-1 patients evaluated at 2500 mg, the highest evaluated dose. Symptom Improvement: Improvements in symptoms were also observed in the majority of patients, with 53% of patients achieving at least a 50% best TSS reduction (TSS50). At Week 24, 32% of patients achieved TSS50, including 29% and 33% of JAK ineligible and JAK R/R/I patients, respectively. Anemia: Rapid and durable anemia improvements were observed in most patients, with anemia response occurring in 60% of evaluable anemic patients, and 52% of patients achieved a major anemia response. Improvements in anemia were observed across patients regardless of prior JAK exposure, including 63% of JAK R/R/I patients and 55% of JAK ineligible patients. Molecular: Consistent reductions in variant allele frequency (VAF) were observed across most patients, regardless of prior JAK exposure and mutation type, with 89% of patients achieving a reduction in whole blood mutCALR VAF (Type 1: 90%, Non-Type 1: 88%), and 81% of patients achieving a ≥25% reduction in mutCALR peripheral blood mononuclear cells (PBMC) from baseline (Type 1: 62%, Non-Type 1: 38%). INCA033989 was generally well-tolerated, with 84% (70/83) of patients remaining on therapy at the time of the data cut off. Treatment emergent adverse events (TEAEs) occurred in 92% (76) of patients, with 27% (22) of patients experiencing Grade ≥3 TEAEs, the most frequent of which were cytopenias. No dose-limiting toxicities were observed, and discontinuations due to TEAEs were limited (n=2).
Combination therapy: INCA033989 (dose range: 70 to 2,500 mg) was evaluated in combination with ruxolitinib in patients with MF who experience a suboptimal response to ruxolitinib monotherapy. INCA033989 demonstrated additive, multi-domain clinical activity in patients when administered in combination with ruxolitinib.
SVR: At Week 24, 55% (11/20) and 30% (6/20) of patients achieved SVR25 and SVR35, respectively. Symptom Improvement: 31% (5/16) of patients achieved TSS50 at Week 24. Anemia: Anemia response occurred in 35% (6/17) of evaluable anemic patients. INCA033989 in combination with ruxolitinib was generally well-tolerated, with 76% (16) of patients remaining on treatment at the time of the data cut off. In the combination arm (n=21), all patients experienced TEAEs. Grade ≥3 TEAEs were reported in 67% (14) of patients, most commonly anemia (33%).
Translational data
Clinical response occurred regardless of mutational complexity with SVR, anemia and molecular responses observed in patients with and without high molecular risk (HMR) mutations. 93% of patients with HMR had a reduction in whole blood mutCALR VAF, as did 88% of those without HMR mutations. A reduction in mutCALR-positive hematopoietic stem and progenitor cells (HSPCs) was also seen, indicating activity at the level of disease-initiating cells. "Patients with CALR-mutated MF have distinct disease biology and often respond poorly to available therapies, underscoring the need for treatments targeting the underlying driver of disease," said Claire Harrison, M.D., Professor of MPNs and Deputy Chief Medical Officer, Guy’s and St. Thomas’ NHS Foundation Trust. "What stands out in these data is that INCA033989 produced rapid and robust spleen, symptom and anemia responses, alongside reductions in mutCALR allele burden regardless of HMR mutations, pointing to activity at the level of the disease-initiating clone."
Results in Patients with Essential Thrombocythemia
In patients with ET, INCA033989 demonstrated rapid, deep and durable hematologic and molecular responses across both Type 1 and non-Type 1 CALR patients, supporting potential for disease modification in a population resistant or intolerant to prior cytoreductive therapy.
Hematologic Response:
Across doses, 70% (80/114) of patients achieved a complete hematologic response (CHR, platelet count ≤400 × 109/L and leukocytes <10 × 109/L) and 87% achieved complete or partial hematologic response (CHR/PHR, platelet count ≤600 × 109/L and leukocytes <10 × 109/L). 81% of patients with Type 1 mutCALR achieved a durable (>12 weeks) CHR at 750 mg and above; and 50% of patients with non–Type 1 mutCALR achieved a durable CHR/PHR at 2500 mg. The median time to onset of durable CHR was 2.1 weeks. Molecular Response and Disease Biology:
≥25% reduction in mutCALR VAF correlated with durable CHR (nominal P<0.0001, n=103). Of the patients who achieved a CHR and had ≥1 post-baseline VAF assessment, 73% achieved ≥25% reduction in VAF. Durable molecular response was observed in both Type 1 and non–Type 1 mutCALR. A reduction in mutCALR megakaryocytes was seen in both Type 1 and non-Type 1 patients treated with INCA033989 INCA033989 was well tolerated with 95% of patients remaining on treatment. The median duration of INCA033989 exposure was 8.1 months (range from 0.59 to 27.0 months). A low incidence of Grade ≥3 adverse events was observed (19%); the most common were neutropenia (4.4%) and lipase increase (3.5%). Grade ≥3 cytopenia TEAEs occurred in 6% (7/114) of patients; no Grade ≥3 thrombocytopenia TEAEs were observed.
“In patients with ET who were resistant to or intolerant of prior cytoreductive therapy, INCA033989 resulted in rapid and durable normalization of platelet counts with accompanying molecular responses, with the majority of patients achieving a CHR," said John Mascarenhas, M.D., Professor of Medicine at the Icahn School of Medicine at Mt. Sinai and Director, Center of Excellence for Blood Cancers and Myeloid Disorders, The Tisch Cancer Institute. "As there are currently no mutation-specific treatments available for patients with ET, this approach is critically important for this high-risk patient population. These results provide a strong foundation for advancing INCA033989 into a registrational Phase 3 study."
In November of 2025, INCA033989 was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ET harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy. A Phase 3 study of INCA033989 in mutCALR positive patients with ET who are resistant or intolerant to at least one prior cytoreductive therapy (EXCALIBUR-ET2, NCT07623200) is being initiated in mid-2026.
More information regarding the EHA 2026 Congress can be found on the EHA website: https://ehaweb.org/connect-network/eha2026-congress.
About Myeloproliferative Neoplasms (MPNs) and Mutations in Calreticulin (mutCALR)
Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein folding. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs),1 a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells.2,3 Among two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases.4 In MF, it is estimated that 70-83% of CALR mutations in the U.S. are identified as Type 1, with 15-30% identified as non-Type 1.4,5 There are currently no targeted therapies for CALR mutations.
Incyte is at the forefront of developing novel therapies for patients with mutCALR ET or MF that target only malignant cells, sparing normal cells, including INCA033989, a first-in-class, mutCALR-specific therapy. INCA033989 received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ET harboring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy. A Phase 3 study of INCA033989 in patients with ET with a Type 1 or non-Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy is being initiated (EXCALIBUR-ET2, NCT07623200).
About the INCA33989-101 & INCA33989-102 Trials
The clinical trial program for INCA033989 includes two multicenter, open-label Phase 1 studies, INCA33989-101 (NCT05936359) and INCA33989-102 (NCT06034002). The studies are evaluating the safety, tolerability and efficacy of INCA033989 in ~455 adult (≥18 years old) patients with mutCALR-expressing myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET) and myelofibrosis (MF).
The primary endpoint of the studies is measured by the number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs) and the number of participants with TEAEs leading to dose modification or discontinuation. Secondary endpoints include response rates, mean change of ET total symptom score, percentage of MF patients achieving spleen volume reduction, MF patient anemia response, mean change in disease-related allele burden and various pharmacokinetics measures.
For more information on the studies, please visit: https://clinicaltrials.gov/study/NCT05936359 and https://clinicaltrials.gov/study/NCT06034002.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the presentation of data for INCA033989; the potential for disease modification and the potential to benefit patients offered by INCA033989; expectations regarding ongoing and future clinical trials, including the timing of such trials; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s products; Incyte’s ability to achieve commercial success for its products, once approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
1 Raghavan, M., Wijeyesakere S.J., Peters L.R., Del Cid N. (2013) Calreticulin in the immune system: ins and outs. Trends in Immunology, 34(1):13-21. Link to source (https://www.cell.com/trends/immunology/abstract/S1471-4906(12)00131-7?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1471490612001317%3Fshowall%3Dtrue)
2 Nangalia J. Massie C.E., Baxter E.J., Nice F.L., et al. (2013) Somatic CALR mutations in myeloproliferative neoplasms with nonmutated JAK2. New England Journal of Medicine, 369(25):2391-2405. Link to source (https://www.nejm.org/doi/10.1056/NEJMoa1312542?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200www.ncbi.nlm.nih.gov)
3 Klampfl T., Gisslinger, H., Harutyunyan A.S., et al. (2013) Somatic mutations of calreticulin in myeloproliferative neoplasms. New England Journal of Medicine, 369(25):2379-2390. Link to source (https://www.nejm.org/doi/10.1056/NEJMoa1311347?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200www.ncbi.nlm.nih.gov)
4 Salzman G. and Mullally A. (2026) Novel strategies targeting mutant calreticulin in essential thrombocythemia and myelofibrosis. Blood, 147(12):1267-1277. Link to source (https://doi.org/10.1182/blood.2025028642)
5 Guglielmelli, P., Maccari, C., Sordi, B. et al. Phenotypic correlations of CALR mutation variant allele frequency in patients with myelofibrosis. Blood Cancer J. 13, 21 (2023). Link to source (https://doi.org/10.1038/s41408-023-00786-x)
A month has gone by since the last earnings report for Incyte (INCY - Free Report) . Shares have lost about 1.8% in that time frame, underperforming the S&P 500.
But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Incyte due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important drivers.
INCY Q1 Earnings and Revenues Beat Estimates on Higher Product Sales
Incyte reported first-quarter 2026 adjusted earnings of $1.81 per share, which beat the Zacks Consensus Estimate of $1.38, primarily due to higher product sales. The company reported adjusted earnings of $1.16 per share in the year-ago quarter.
Total revenues in the first quarter were $1.27 billion, which grew 21% year over year, driven primarily by the sustained performance of its lead drug, Jakafi (ruxolitinib), and increased sales of Opzelura (ruxolitinib) cream on strong launch and demand. The top line beat the Zacks Consensus Estimate of $1.23 billion.
All percentages mentioned below are on a reported basis.
INCY's Q1 Results in Detail
Revenues from the sale of Jakafi, a first-in-class JAK1/JAK2 inhibitor approved for polycythemia vera, myelofibrosis and refractory acute graft-versus-host disease (GVHD), amounted to $757.8 million, up 7% from the year-ago quarter, owing to a 6% increase in paid demand. Jakafi's sales beat the Zacks Consensus Estimate of $735.6 million.
Opzelura (ruxolitinib) cream, approved for atopic dermatitis and vitiligo, generated $143 million in sales, which rose 20% year over year, but missed the Zacks Consensus Estimate of $160.4 million. The year-over-year rise in sales was driven by increased patient demand and refills in the United States for both its approved indications.
The newly approved medicine Zynyz (retifanlimab-dlwr) generated sales of $41.4 million, which significantly increased from the year-ago quarter’s level and beat the Zacks Consensus Estimate of $30.8 million. The company obtained accelerated approval for Zynyz to treat metastatic or recurrent locally advanced Merkel cell carcinoma.
Net product revenues of Iclusig were $35.5 million, up 20% year over year. The figure beat the Zacks Consensus Estimate of $32.8 million. Pemazyre generated $22.5 million in sales, reflecting a year-over-year increase of 22%. The figure also surpassed the Zacks Consensus Estimate of $22 million.
Minjuvi's revenues totaled $49.2 million, up 67% year over year. The figure beat the Zacks Consensus Estimate of $43.6 million. Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG, which is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets in 2024.
Incyte and partner Syndax Pharmaceuticals obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. The candidate was approved under the brand name Niktimvo.
The drug is Incyte’s second approved treatment for chronic GVHD (third-line) and was launched in the United States during the first quarter of 2025. The drug recorded $55.1 million in sales in the first quarter of 2026, up significantly on a year-over-year basis, driven by strong uptake, but missed the Zacks Consensus Estimate of $56 million.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi in ex-U.S. markets. Jakavi royalty revenues from Novartis for commercialization in ex-U.S. markets rose 15% to $105.6 million. Jakavi royalties beat the Zacks Consensus Estimate of $97 million.
Incyte also receives royalties from the sales of Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small-cell lung cancer. Its partner, Novartis, has exclusive worldwide development and commercialization rights for Tabrecta. Royalty revenues from the drug’s sales amounted to $6 million, down 7% year over year. The reported figure missed the Zacks Consensus Estimate of $6.8 million.
Olumiant’s (baricitinib) product royalty revenues from Eli Lilly totaled $36.4 million, up 18% year over year. The figure beat the Zacks Consensus Estimate of $35.3 million. Incyte has a collaboration agreement with Eli Lilly for Olumiant. The drug is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. It is approved for several types of autoimmune diseases.
Adjusted research and development (R&D) expenses totaled $476.7 million, up 19% year over year. This increase was primarily due to continued investment in late-stage development assets.
Adjusted selling, general and administrative (SG&A) expenses were $304.1 million, up 1% from the prior-year quarter’s number.
INCY’s cash, cash equivalents and marketable securities amounted to $4 billion as of March 31, 2026, compared with the $3.6 billion recorded as of Dec. 31, 2025.
INCY Reiterates 2026 Guidance
The company continues to expect Jakafi revenues in the range of $3.22-$3.27 billion in 2026. Opzelura net product revenues are expected to remain in the band of $750-$790 million in 2026. Net product revenues for 2026 are expected to be in the range of $4.77-$4.94 billion.
Total adjusted R&D expenses and SG&A expenses are expected in the range of $3.205-$3.375 billion.
How Have Estimates Been Moving Since Then?It turns out, fresh estimates have trended upward during the past month.
The consensus estimate has shifted 6.25% due to these changes.
VGM ScoresAt this time, Incyte has a great Growth Score of A, though it is lagging a bit on the Momentum Score front with a B. Following the exact same course, the stock has a score of B on the value side, putting it in the second quintile for value investors.
Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, Incyte has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Incyte's Monjuvi as part of a multi-drug regimen that includes a chemotherapy standard of care for an aggressive form of non-Hodgkin lymphoma reduced the risk of disease progression, relapse or death by 25% compared to the standard alone, but with a higher rate of study dropouts due to side effects.
- Late-breaking rapid-fire presentation to include results from Cohort 1 of the placebo-controlled PROGRESS study evaluating zilurgisertib in fibrodysplasia ossificans progressiva (FOP)
FOSTER CITY, Calif. & WILMINGTON, Del.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) and Incyte (Nasdaq: INCY) today announced that pivotal Phase 2 results from the PROGRESS study evaluating zilurgisertib, an investigational ALK2 inhibitor, in patients with fibrodysplasia ossificans progressiva (“FOP”) will be presented at ENDO 2026, the Endocrine Society’s annual meeting, taking place June 13-16, 2026, in Chicago, Illinois.
Late-breaking rapid-fire presentation to include results from Cohort 1 of the placebo-controlled PROGRESS study evaluating zilurgisertib in fibrodysplasia ossificans progressiva (FOP).
Share The late-breaking rapid-fire presentation will include results from Cohort 1 of the placebo-controlled PROGRESS study, which enrolled patients 12 years of age and older and formed the basis of the New Drug Application (NDA) for zilurgisertib to the U.S. Food and Drug Administration (FDA).
In April 2026, Mirum entered into an exclusive license agreement with Incyte for worldwide rights to zilurgisertib.
“ENDO 2026 is an important milestone for the zilurgisertib FOP program as we share pivotal results from the PROGRESS study in patients living with this debilitating disease,” said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development at Incyte. “These data add to the growing clinical understanding of zilurgisertib’s potential in FOP as Incyte and Mirum continue to advance toward the FDA’s Priority Review PDUFA date of September 26, 2026.”
“FOP is a devastating, progressive disease that profoundly impacts patients and families,” said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. “At Mirum, in partnership with Incyte, we are committed to advancing zilurgisertib with urgency as we work toward potentially bringing a needed new treatment option to people living with FOP.”
Congress Presentation
Additional details regarding the presentation are as follows:
Abstracts accepted for presentation at ENDO 2026 will be available once published through the Endocrine Society’s ENDO 2026 website.
About Zilurgisertib
Zilurgisertib is an investigational, oral, small molecule, activin receptor-like kinase 2 (ALK2) inhibitor in development for the treatment of Fibrodysplasia Ossificans Progressiva (FOP). Zilurgisertib is designed to inhibit the ALK2 receptor, which is abnormally active in most patients with FOP and leads to bone formation in soft tissues, a process known as heterotopic ossification (HO). FOP is an ultra-rare genetic disease that affects approximately 300 patients in the U.S. and 900 worldwide, with diagnosis typically occurring in early childhood. Zilurgisertib was evaluated in the PROGRESS pivotal Phase 2 study, which formed the basis of a new drug application (NDA). The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.
Mirum licensed zilurgisertib from Incyte for development and commercialization globally.
About the PROGRESS Study
PROGRESS is a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of zilurgisertib in patients with fibrodysplasia ossificans progressiva (FOP). PROGRESS Cohort 1 enrolled patients 12 years of age and older who were randomized 1:1 to receive zilurgisertib 100 mg once daily or placebo during a 24-week double-blind treatment period, followed by an open-label extension. Additional PROGRESS cohorts will evaluate the efficacy and safety of zilurgisertib in patients ages 6 to <12 years of age (Cohort 2) and in patients ages 2 to <12 years of age (Cohort 3).
The primary endpoint of the study is the proportion of Cohort 1 patients with new heterotopic ossification (HO) lesions at Week 24 as assessed by whole-body CT scan data. Key secondary endpoints include the number and total volume of new HO lesions, changes in total HO lesion volume and flare activity through Week 24.
About Mirum Pharmaceuticals
Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX).
Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS).
Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Mirum Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company’s planned participation at a scientific congress, Mirum’s continued advancement of zilurgisertib with Incyte, the FDA approval pathway for zilurgisertib and the potential benefit of zilurgisertib in real world settings versus scientific presentations of data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential and promise suggested by the Phase 2 PROGRESS results, the potential for zilurgisertib to become a treatment option for people living with FOP, Incyte’s plans and expectations for the PROGRESS study and Incyte’s aspirations and goals as set forth under the heading “About Incyte”.
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the ability of Incyte’s collaborators to achieve commercial success for their marketed products and product candidates, if approved; Incyte’s and Incyte’s collaborators’ ability to obtain and maintain protection of intellectual property for their products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s collaborators’ products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Mirum and the Mirum logo are trademarks of Mirum Pharmaceuticals, Inc.
More News From Mirum Pharmaceuticals, Inc. and Incyte
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) and Incyte (Nasdaq: INCY) today announced that pivotal Phase 2 results from the PROGRESS study evaluating zilurgisertib, an investigational ALK2 inhibitor, in patients with fibrodysplasia ossificans progressiva (“FOP”) will be presented at ENDO 2026, the Endocrine Society’s annual meeting, taking place June 13-16, 2026, in Chicago, Illinois.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260604863826/en/
The late-breaking rapid-fire presentation will include results from Cohort 1 of the placebo-controlled PROGRESS study, which enrolled patients 12 years of age and older and formed the basis of the New Drug Application (NDA) for zilurgisertib to the U.S. Food and Drug Administration (FDA).
In April 2026, Mirum entered into an exclusive license agreement with Incyte for worldwide rights to zilurgisertib.
“ENDO 2026 is an important milestone for the zilurgisertib FOP program as we share pivotal results from the PROGRESS study in patients living with this debilitating disease,” said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development at Incyte. “These data add to the growing clinical understanding of zilurgisertib’s potential in FOP as Incyte and Mirum continue to advance toward the FDA’s Priority Review PDUFA date of September 26, 2026.”
“FOP is a devastating, progressive disease that profoundly impacts patients and families,” said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. “At Mirum, in partnership with Incyte, we are committed to advancing zilurgisertib with urgency as we work toward potentially bringing a needed new treatment option to people living with FOP.”
Congress Presentation
Additional details regarding the presentation are as follows:
Abstract #
ORF37-04
Title
Zilurgisertib in Patients with Fibrodysplasia Ossificans Progressiva: Interim Results from the PROGRESS Study
Date/Time
Sunday, June 14, 3:30-4:15 pm CT
Abstracts accepted for presentation at ENDO 2026 will be available once published through the Endocrine Society’s ENDO 2026 website.
About Zilurgisertib
Zilurgisertib is an investigational, oral, small molecule, activin receptor-like kinase 2 (ALK2) inhibitor in development for the treatment of Fibrodysplasia Ossificans Progressiva (FOP). Zilurgisertib is designed to inhibit the ALK2 receptor, which is abnormally active in most patients with FOP and leads to bone formation in soft tissues, a process known as heterotopic ossification (HO). FOP is an ultra-rare genetic disease that affects approximately 300 patients in the U.S. and 900 worldwide, with diagnosis typically occurring in early childhood. Zilurgisertib was evaluated in the PROGRESS pivotal Phase 2 study, which formed the basis of a new drug application (NDA). The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.
Mirum licensed zilurgisertib from Incyte for development and commercialization globally.
About the PROGRESS Study
PROGRESS is a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of zilurgisertib in patients with fibrodysplasia ossificans progressiva (FOP). PROGRESS Cohort 1 enrolled patients 12 years of age and older who were randomized 1:1 to receive zilurgisertib 100 mg once daily or placebo during a 24-week double-blind treatment period, followed by an open-label extension. Additional PROGRESS cohorts will evaluate the efficacy and safety of zilurgisertib in patients ages 6 to <12 years of age (Cohort 2) and in patients ages 2 to <12 years of age (Cohort 3).
The primary endpoint of the study is the proportion of Cohort 1 patients with new heterotopic ossification (HO) lesions at Week 24 as assessed by whole-body CT scan data. Key secondary endpoints include the number and total volume of new HO lesions, changes in total HO lesion volume and flare activity through Week 24.
About Mirum Pharmaceuticals
Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX).
Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS).
Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Mirum Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the Company’s planned participation at a scientific congress, Mirum’s continued advancement of zilurgisertib with Incyte, the FDA approval pathway for zilurgisertib and the potential benefit of zilurgisertib in real world settings versus scientific presentations of data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential and promise suggested by the Phase 2 PROGRESS results, the potential for zilurgisertib to become a treatment option for people living with FOP, Incyte’s plans and expectations for the PROGRESS study and Incyte’s aspirations and goals as set forth under the heading “About Incyte”.
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the ability of Incyte’s collaborators to achieve commercial success for their marketed products and product candidates, if approved; Incyte’s and Incyte’s collaborators’ ability to obtain and maintain protection of intellectual property for their products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s collaborators’ products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
Mirum and the Mirum logo are trademarks of Mirum Pharmaceuticals, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260604863826/en/
US biotech Incyte Pharma is nearing a deal for up to $2 billion to buy blood disorder drug developer Star Therapeutics, the Financial Times reported on Sunday, citing people familiar with the matter.
- Proposed acquisition to add VGA039, a novel investigational monoclonal antibody that targets Protein S in Phase 3 development for von Willebrand disease (VWD)
- Star Therapeutics to receive $1.25 billion upfront, with up to $750 million in additional payments upon achievement of sales milestones
- Incyte will host an analyst and investor call on Monday, June 8, 2026, at 8:00 a.m. ET
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) announced today it has entered into a definitive agreement to acquire Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC, for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones, for total potential consideration of up to $2.0 billion subject to customary closing adjustments. The proposed acquisition would add VGA039, a novel monoclonal antibody, to Incyte’s hematology portfolio.
“VGA039 fits directly into our strategy of building a top-tier growth company for the future,” said Bill Meury, Chief Executive Officer of Incyte.
Share Vega Therapeutics’ lead candidate, VGA039, modulates Protein S to improve hemostasis, potentially improving the body’s ability to control bleeding in numerous bleeding disorders. VGA039 is in Phase 3 pivotal development for patients with von Willebrand disease (VWD), the most common inherited bleeding disorder. It has the potential to be the first subcutaneous prophylactic therapy with a convenient dosing regimen for patients with VWD who currently require frequent intravenous infusions.
“VGA039 fits directly into our strategy of building a top-tier growth company for the future,” said Bill Meury, Chief Executive Officer of Incyte. “It is a first-in-class, Phase 3 asset with compelling early data, a manageable development path and the potential to become an important new growth driver in one of our core therapeutic areas – hematology. The transaction has all of the attributes we look for in business development opportunities.”
Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1 The disease is characterized by excessive bleeding that can vary in severity and frequency and may significantly affect quality of life. Current prophylactic treatment options include factor replacement therapies that often require 2 to 3 intravenous infusions each week.2
“This milestone reflects our team’s deep commitment to innovation and underscores our strategy to develop first-in-class and best-in-class therapies for serious conditions with high unmet need,” said Adam Rosenthal, Ph.D., Founder and Chief Executive Officer of Star Therapeutics. “VGA039 will be advanced by Incyte, a global biopharmaceutical leader with deep expertise in hematology and a significant commercial track record. I am immensely proud of the Star Therapeutics team and our work toward making a difference for patients with von Willebrand disease.”
VGA039 has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.
The transaction has been approved by both Incyte’s and Star Therapeutics’ Boards of Directors. Under the terms of the stock purchase agreement, Incyte will acquire all the outstanding shares of Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is an equity acquisition and is expected to close in the third quarter of 2026, pending Hart-Scott-Rodino review resulting in an expected R&D charge of approximately $1.25 billion, that will be included in third quarter and full year 2026 GAAP and non-GAAP results.
Lazard is acting as financial advisor to Incyte and Goodwin Procter LLP is serving as its legal counsel. Evercore and Morgan Stanley are acting as financial advisors to Star Therapeutics, and Fenwick & West LLP is serving as its legal counsel.
Incyte Conference Call and Webcast
Incyte will host a conference call and webcast on Monday, June 8, 2026, at 8:00 a.m. ET to discuss the acquisition.
To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13761011. If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay, you will need the conference identification number, 13761011.
The live and archived webcast will be available via the Events and Presentations tab of the Investor section of Incyte.com.
About VGA039
VGA039 is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. VGA039 has the potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, starting with all types of von Willebrand disease (VWD). As a subcutaneously self-administered investigational antibody therapy with a convenient once monthly dosing regimen, VGA039 has the potential to meaningfully improve convenience and quality of life for patients.
VGA039 has received Fast Track, orphan drug, rare pediatric disease and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into a Phase 3 study (NCT07115004), VIVID-6, a global single arm cross-over study designed to investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD.
About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1
About Star Therapeutics
Star Therapeutics is a biotechnology company focused on the discovery and development of life-changing therapies for diseases with significant unmet need. Star Therapeutics' team has invented four first-in-class antibody therapies, including the first approved drug (Enjaymo®) for cold agglutinin disease, and three other therapies that are each in Phase 3 development. For more information, please visit Star-Therapeutics.com and follow us on LinkedIn and X.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the anticipated benefits of the Vega Therapeutics acquisition; costs and other anticipated financial impacts of the acquisition; expectations regarding VGA039’s development and its potential to become an important new growth driver for Incyte’s hematology portfolio; the potential and promise VGA039 offers patients with bleeding disorders and its ability to address significant unmet need; Incyte’s strategy of building a top-tier growth company for the future; expectations regarding the closing of the proposed transaction, including the expected timing of the same; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including unexpected costs, charges or expenses resulting from the acquisition; the risk that Incyte may not be able to successfully integrate the business of Vega Therapeutics and realize the expected benefits of the acquisition in a timely manner or at all; the sufficiency of clinical trial data for VGA039, as well as Incyte’s other products and product candidates, to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for VGA039, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
U.S. dollar banknotes are seen in this illustration taken March 24, 2026. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights, opens new tab
CompaniesJune 8 (Reuters) - Incyte (INCY.O), opens new tab said on Monday it will buy Vega Therapeutics, a wholly owned subsidiary of privately held Star Therapeutics, in a deal worth up to $2 billion, expanding its pipeline for blood disorder therapies.
The deal includes $1.25 billion cash upfront and up to $750 million in milestone payments, the U.S. drugmaker said.
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The acquisition gives Incyte a late-stage drug candidate for bleeding disorders, as it faces pressure on its top-selling blood cancer drug Jakafi when patent protections begin to wane around 2028.
Vega Therapeutics develops antibody therapies for rare blood disorders. The parent company, Star, spun out Vega as a separate startup in December 2022.
Its lead experimental drug, VGA039, is a monoclonal antibody being tested in patients with von Willebrand disease, the most common inherited bleeding disorder, in which blood does not clot properly due to the absence of a protein.
'TEXTBOOK' TYPE OF DEALIncyte CEO Bill Meury called the deal a "textbook" fit for the company's strategy.
"It (the deal) really checks all the boxes," Meury said, but noted that it was unlikely that they "replace Jakafi with one big swing."
Jakafi recorded sales of about $3.09 billion in 2025.
VGA039 is in a late-stage trial, with results expected in early 2029 and a potential launch after Jakafi is expected to lose patent protection.
Unlike current treatments requiring intravenous infusions multiple times a week, VGA039 offers the convenience of being administered once a month via subcutaneous injection.
Incyte Executive Vice President Dave Gardner said VGA039 could be priced at around $500,000 per year.
Truist analyst Srikripa Deverakonda estimated $1 billion in peak sales by 2036, with revenue ramping from 2030, and said that "the focus for commercialization will be Incyte's ability to generate switches to a monthly subcutaneous therapy."
The transaction is expected to close in the third quarter of 2026.
Reporting by Siddhi Mahatole in Bengaluru; Editing by Sahal Muhammed and Vijay Kishore
Our Standards: The Thomson Reuters Trust Principles., opens new tab
Incyte has agreed to buy Vega Therapeutics for up to $2 billion in a deal that expands the biopharmaceutical company's hematology portfolio into bleeding disorders.
Incyte (Nasdaq:INCY) announced today it has entered into a definitive agreement to acquire Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics, LLC, for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones, for total potential consideration of up to $2.0 billion subject to customary closing adjustments. The proposed acquisition would add VGA039, a novel monoclonal antibody, to Incyte’s hematology portfolio.
Vega Therapeutics’ lead candidate, VGA039, modulates Protein S to improve hemostasis, potentially improving the body’s ability to control bleeding in numerous bleeding disorders. VGA039 is in Phase 3 pivotal development for patients with von Willebrand disease (VWD), the most common inherited bleeding disorder. It has the potential to be the first subcutaneous prophylactic therapy with a convenient dosing regimen for patients with VWD who currently require frequent intravenous infusions.
“VGA039 fits directly into our strategy of building a top-tier growth company for the future,” said Bill Meury, Chief Executive Officer of Incyte. “It is a first-in-class, Phase 3 asset with compelling early data, a manageable development path and the potential to become an important new growth driver in one of our core therapeutic areas – hematology. The transaction has all of the attributes we look for in business development opportunities.”
Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1 The disease is characterized by excessive bleeding that can vary in severity and frequency and may significantly affect quality of life. Current prophylactic treatment options include factor replacement therapies that often require 2 to 3 intravenous infusions each week.2
“This milestone reflects our team’s deep commitment to innovation and underscores our strategy to develop first-in-class and best-in-class therapies for serious conditions with high unmet need,” said Adam Rosenthal, Ph.D., Founder and Chief Executive Officer of Star Therapeutics. “VGA039 will be advanced by Incyte, a global biopharmaceutical leader with deep expertise in hematology and a significant commercial track record. I am immensely proud of the Star Therapeutics team and our work toward making a difference for patients with von Willebrand disease.”
VGA039 has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.
The transaction has been approved by both Incyte’s and Star Therapeutics’ Boards of Directors. Under the terms of the stock purchase agreement, Incyte will acquire all the outstanding shares of Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is an equity acquisition and is expected to close in the third quarter of 2026, pending Hart-Scott-Rodino review resulting in an expected R&D charge of approximately $1.25 billion, that will be included in third quarter and full year 2026 GAAP and non-GAAP results.
Lazard is acting as financial advisor to Incyte and Goodwin Procter LLP is serving as its legal counsel. Evercore and Morgan Stanley are acting as financial advisors to Star Therapeutics, and Fenwick & West LLP is serving as its legal counsel.
Incyte Conference Call and Webcast
Incyte will host a conference call and webcast on Monday, June 8, 2026, at 8:00 a.m. ET to discuss the acquisition.
To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13761011. If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay, you will need the conference identification number, 13761011.
The live and archived webcast will be available via the Events and Presentations tab of the Investor section of Incyte.com.
About VGA039
VGA039 is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. VGA039 has the potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, starting with all types of von Willebrand disease (VWD). As a subcutaneously self-administered investigational antibody therapy with a convenient once monthly dosing regimen, VGA039 has the potential to meaningfully improve convenience and quality of life for patients.
VGA039 has received Fast Track, orphan drug, rare pediatric disease and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). VGA039 has advanced into a Phase 3 study (NCT07115004), VIVID-6, a global single arm cross-over study designed to investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD.
About von Willebrand Disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by low or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with varying severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. Approximately 135,000 people in the United States have been diagnosed with von Willebrand disease.1
About Star Therapeutics
Star Therapeutics is a biotechnology company focused on the discovery and development of life-changing therapies for diseases with significant unmet need. Star Therapeutics' team has invented four first-in-class antibody therapies, including the first approved drug (Enjaymo®) for cold agglutinin disease, and three other therapies that are each in Phase 3 development. For more information, please visit Star-Therapeutics.com and follow us on LinkedIn and X.
About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.
To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.
Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the anticipated benefits of the Vega Therapeutics acquisition; costs and other anticipated financial impacts of the acquisition; expectations regarding VGA039’s development and its potential to become an important new growth driver for Incyte’s hematology portfolio; the potential and promise VGA039 offers patients with bleeding disorders and its ability to address significant unmet need; Incyte’s strategy of building a top-tier growth company for the future; expectations regarding the closing of the proposed transaction, including the expected timing of the same; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”
Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including unexpected costs, charges or expenses resulting from the acquisition; the risk that Incyte may not be able to successfully integrate the business of Vega Therapeutics and realize the expected benefits of the acquisition in a timely manner or at all; the sufficiency of clinical trial data for VGA039, as well as Incyte’s other products and product candidates, to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for VGA039, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.
_____________________________ 1
Data on File. 2
Franchini M, et al. Prophylactic management of patients with von Willebrand disease. Ther Adv Hematol. 2021;12.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260608789389/en/
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VGM ScoreIf you like to use all three kinds of investing, then the VGM Score is for you. It's a combination of all Style Scores, and is an important indicator to use with the Zacks Rank. The VGM Score rates each stock on their shared weighted styles, narrowing down the companies with the most attractive value, best growth forecast, and most promising momentum.
How Style Scores Work with the Zacks Rank The Zacks Rank is a proprietary stock-rating model that harnesses the power of earnings estimate revisions, or changes to a company's earnings expectations, to help investors build a successful portfolio.
#1 (Strong Buy) stocks have produced an unmatched +23.7% average annual return since 1988, which is more than double the S&P 500's performance over the same time frame. However, the Zacks Rank examines a ton of stocks, and there can be more than 200 companies with a Strong Buy rank, and another 600 with a #2 (Buy) rank, on any given day.
But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.
That's where the Style Scores come in.
You want to make sure you're buying stocks with the highest likelihood of success, and to do that, you'll need to pick stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you like a stock that only has a #3 (Hold) rank, it should also have Scores of A or B to guarantee as much upside potential as possible.
The direction of a stock's earnings estimate revisions should always be a key factor when choosing which stocks to buy, since the Scores were created to work together with the Zacks Rank.
Here's an example: a stock with a #4 (Sell) or #5 (Strong Sell) rating, even one with Style Scores of A and B, still has a downward-trending earnings outlook, and a bigger chance its share price will decrease too.
Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.
Stock to Watch: Incyte (INCY - Free Report) Wilmington, Delaware based Incyte Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. The company conducts its European clinical development operations in Geneva, Switzerland.
INCY is a #3 (Hold) on the Zacks Rank, with a VGM Score of B.
Additionally, the company could be a top pick for growth investors. INCY has a Growth Style Score of A, forecasting year-over-year earnings growth of 12.5% for the current fiscal year.
Eight analysts revised their earnings estimate higher in the last 60 days for fiscal 2026, while the Zacks Consensus Estimate has increased $0.13 to $7.65 per share. INCY also boasts an average earnings surprise of +18.3%.
With a solid Zacks Rank and top-tier Growth and VGM Style Scores, INCY should be on investors' short list.
Incyte Corporation (NASDAQ:INCY) said Monday it has agreed to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, in a deal valued at $1.25 billion upfront.
The transaction will add late-stage candidate VGA039 to Incyte's hematology portfolio and could reach a total value of $2 billion if certain sales milestones are achieved.
• Incyte shares are powering higher. What’s fueling INCY momentum?
Deal Brings Late-Stage Von Willebrand Disease Therapy To IncyteUnder the terms of the agreement, Star Therapeutics could receive up to $750 million in additional milestone payments tied to future sales performance.
The centerpiece of the deal is VGA039, a novel monoclonal antibody designed to modulate Protein S and improve hemostasis, potentially helping the body better control bleeding in a range of bleeding disorders.
VGA039 is currently in Phase 3 pivotal development for patients with von Willebrand disease (VWD), the most common inherited bleeding disorder.
The therapy has the potential to become the first subcutaneous prophylactic treatment for VWD patients, offering a more convenient dosing option than existing therapies that often require frequent intravenous infusions.
Incyte Highlights Growth PotentialBill Meury, CEO of Incyte, said VGA039 aligns with the company’s strategy of building a long-term growth business.
Meury described the asset as a first-in-class Phase 3 program with encouraging early data, a manageable development pathway, and the potential to become a meaningful growth contributor within Incyte's hematology franchise.
According to the company, approximately 135,000 people in the U.S. have been diagnosed with VWD.
The disorder is characterized by excessive bleeding that can vary in severity and frequency and may significantly affect quality of life.
Regulatory Support and Ongoing Phase 3 StudyVGA039 has received Breakthrough Therapy, Fast Track, orphan drug, and rare pediatric disease designations from the U.S. Food and Drug Administration.
The candidate has advanced into the Phase 3 VIVID-6 study, a global single-arm crossover trial evaluating the safety and efficacy of subcutaneous VGA039 as prophylactic treatment for bleeding in patients across all forms.
Analyst Highlights Strategic FitWilliam Blair wrote, “Overall, we believe the deal for VGA039 fits well into Incyte's current hematology franchise and capabilities, and offers a relatively de-risked Phase 3 asset with blockbuster commercial potential in the 2030s.”
Analyst Matt Phipps on Monday wrote that even with conservative assumptions around pricing and market penetration, VGA039 has a clear path to a more than $1 billion market opportunity.
INCY Stock Price Activity: Incyte shares were up 3.01% at $103.67 at the time of publication on Tuesday, according to Benzinga Pro data.
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Key Takeaways Incyte plans to acquire Vega Therapeutics for up to $2B, adding late-stage VWD candidate VGA039.INCY expects a $1.25B R&D charge at closing, with the deal targeted to close in Q3 2026.VGA039 is in phase III testing and could become the first subcutaneous preventive VWD treatment. Incyte (INCY - Free Report) announced that it will acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, for a potential consideration of up to $2 billion.
The proposed acquisition will add Vega Therapeutics’ lead candidate, VGA039, a novel monoclonal antibody, to Incyte’s hematology portfolio.
However, INCY was down 1.7% on the news probably due to high R&D charges associated with the acquisition.
INCY’s shares have gained 1.9% year to date against the industry’s decline of 3.2%.
Image Source: Zacks Investment Research
More on INCY’s Proposed Vega AcquisitionVega Therapeutics’ lead asset, VGA039, is a novel monoclonal antibody designed to improve hemostasis by modulating protein S, thereby enhancing the body's ability to control bleeding.
The therapy is being evaluated for patients with von Willebrand disease (VWD). If approved, VGA039 could become the first subcutaneous preventive treatment for VWD, offering a more convenient dosing option compared with the frequent intravenous infusions required by existing therapies.
VWD is the most common inherited bleeding disorder, affecting approximately 135,000 people in the United States.
VGA039 has received Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA, highlighting its potential to address a significant unmet need in VWD.
The candidate is currently being evaluated in the phase III VIVID-6 study (NCT07115004), a global single-arm crossover study assessing the safety and efficacy of subcutaneous VGA039 as a preventive treatment for bleeding across all VWD subtypes, including patients with severe disease burden.
Under the terms of the agreement, Star Therapeutics will receive $1.25 billion upfront and will be eligible for up to $750 million in additional milestone payments tied to future sales performance.
The acquisition has been unanimously approved by the boards of both Incyte and Star Therapeutics. Under the agreement, Incyte will acquire all outstanding shares of Vega Therapeutics, Star's wholly owned subsidiary. The transaction is expected to be closed in the third quarter of 2026, subject to customary closing conditions and regulatory clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Upon closing, Incyte expects to record an approximately $1.25 billion in R&D charge, which will be reflected in its third-quarter and full-year 2026 results.
INCY Looks to Strengthen Pipeline/PortfolioIncyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
At present, the lead drug Jakafi accounts for the majority of revenues.
The lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Encouraging uptake of new drugs like Pemazyre and Monjuvi also contributes to its top-line growth.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets.
Incyte earns product royalty revenues from Novartis for the commercialization of Jakavi in ex-U.S. markets.
Novartis also has exclusive worldwide development and commercialization rights to Tabrecta.
The Vega acquisition aligns closely with Incyte's established hematology business, allowing the company to leverage its existing R&D and commercial infrastructure while expanding its growth opportunities across both U.S. and international markets.
VGA039 is a promising late-stage hematology asset with significant commercial potential. The candidate represents a potential blockbuster opportunity with projected annual sales exceeding $1 billion and is expected to become a meaningful contributor to Incyte’s growth beyond 2029.
INCY’s Zacks Rank & Stocks to ConsiderINCY currently carries a Zacks Rank #3 (Hold). A couple of 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 60 days, estimates for Liquidia’s 2026 EPS 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 surged 85.3% 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 60 days, estimates for Immunocore’s 2026 earnings have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
Incyte is upgraded to Buy as pipeline progress and improved EPS estimates offset Jakafi concentration risk. frontMIND Phase 3 data for Monjuvi in first-line DLBCL is promising, supporting potential market share gains despite emerging competition. INCY acquired Vega Therapeutics, adding VGA039 to its hematology portfolio.
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.
The research service features daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, all of which will help you become a smarter, more confident investor.
Zacks Premium also includes the Zacks Style Scores.
What are the Zacks Style Scores? Developed alongside the Zacks Rank, the Zacks Style Scores are a group of complementary indicators that help investors pick stocks with the best chances of beating the market over the next 30 days.
Each stock is assigned a rating of A, B, C, D, or F based on their value, growth, and momentum characteristics. Just like in school, an A is better than a B, a B is better than a C, and so on -- that means the better the score, the better chance the stock will outperform.
The Style Scores are broken down into four categories:
Value ScoreFor value investors, it's all about finding good stocks at good prices, and discovering which companies are trading under their true value before the broader market catches on. The Value Style Score utilizes ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to help pick out the most attractive and discounted stocks.
Growth ScoreGrowth investors are more concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, the Growth Style Score analyzes characteristics like projected and historic earnings, sales, and cash flow to find stocks that will see sustainable growth over time.
Momentum ScoreMomentum trading is all about taking advantage of upward or downward trends in a stock's price or earnings outlook, and these investors live by the saying "the trend is your friend." The Momentum Style Score can pinpoint good times to build a position in a stock, using factors like one-week price change and the monthly percentage change in earnings estimates.
VGM ScoreWhat if you like to use all three types of investing? The VGM Score is a combination of all Style Scores, making it one of the most comprehensive indicators to use with the Zacks Rank. It rates each stock on their combined weighted styles, which helps narrow down the companies with the most attractive value, best growth forecast, and most promising momentum.
How Style Scores Work with the Zacks Rank The Zacks Rank, which is a proprietary stock-rating model, employs earnings estimate revisions, or changes to a company's earnings expectations, to make building a winning portfolio easier.
Investors can count on the Zacks Rank's success, with #1 (Strong Buy) stocks producing an unmatched +23.7% average annual return since 1988, more than double the S&P 500's performance. But the model rates a large number of stocks, and there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.
But it can feel overwhelming to pick the right stocks for you and your investing goals with over 800 top-rated stocks to choose from.
That's where the Style Scores come in.
You want to make sure you're buying stocks with the highest likelihood of success, and to do that, you'll need to pick stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you like a stock that only has a #3 (Hold) rank, it should also have Scores of A or B to guarantee as much upside potential as possible.
As mentioned above, the Scores are designed to work with the Zacks Rank, so any change to a company's earnings outlook should be a deciding factor when picking which stocks to buy.
A stock with a #4 (Sell) or #5 (Strong Sell) rating, for instance, even one with Scores of A and B, will still have a declining earnings forecast, and a greater chance its share price will fall too.
Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.
Stock to Watch: Incyte (INCY - Free Report) Wilmington, Delaware based Incyte Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. The company conducts its European clinical development operations in Geneva, Switzerland.
INCY is a #3 (Hold) on the Zacks Rank, with a VGM Score of B.
It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 13.8; value investors should take notice.
For fiscal 2026, seven analysts revised their earnings estimate upwards in the last 60 days, and the Zacks Consensus Estimate has increased $0.08 to $7.64 per share. INCY boasts an average earnings surprise of +18.3%.
With a solid Zacks Rank and top-tier Value and VGM Style Scores, INCY should be on investors' short list.
Incyte (INCY) is working its way up toward a buy point at 112.29. The biotech — which announced a major acquisition this week — is today's selection for IBD 50 Stocks To Watch.
The stock is forming a long base, but it already cleared an entry near 101 from a trendline that touched the highs starting on Jan. 7.
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This is an early-stage base that gives it an advantage over late-stage patterns.
The company delivered an earnings beat for the first quarter with $1.81 per share. Sales came in at $1.3 billion. Earnings grew 56% while sales increased 21% from the prior year.
Analysts polled by FactSet had estimated $1.32 in earnings per share with sales of $1.22 billion.
Analysts have raised their full-year profit estimates for the biotech. Profits are seen rising 11% in 2026 to $7.57 per share. In 2027, Wall Street targets earnings of $9.04 per share. That would be a 20% increase from the current year.
Sales from the company's main drug, Jakafi, which treats two types of blood cancer, rose 7% year over year to $758 million. For the full year, the company expects Jakafi sales of $3.25 billion at the midpoint of its forecast. In 2025, sales were $3.092 billion, according to Incyte's annual SEC filing.
Although sales for its eczema drug Opzelura missed Wall Street's target, the company maintained the drug's midpoint estimate of $770 million in full-year sales.
The company last Monday announced plans to acquire Vega Therapeutics from privately held Star Therapeutics in a $1.25 billion deal. Star Therapeutics will be eligible for additional payments of up to $750 million based on sales milestones, bringing a total potential price tag of $2 billion.
Vega's lead candidate drug is a treatment to improve the body's ability to control bleeding in patients with inherited bleeding disorders. Bill Meury, Chief Executive of Incyte, noted that Vega's drug has "compelling early data, a manageable development path and the potential to become an important new growth driver in one of our core therapeutic areas — hematology."
Biotech Stock: Strong Earnings Record Incyte has a Composite Rating of 85 while the EPS Rating sits at 96 and reflects the acceleration in earnings growth in the most recent quarter. The Relative Strength Rating of 71 does not meet the recommended threshold of 80 for growth stocks.
More funds have bought shares of Incyte over the past five quarters. However, institutional support has been weak over the most recent 13 weeks, giving the stock a worst-possible Accumulation/Distribution Rating of E.
But overall demand for the stock has been on the higher side over the past 50 days, going by an up/down volume ratio of 1.3. The Federated Hermes MDT Large-Cap Growth Fund (QILGX) holds shares of Incyte. The fund is in the IBD mutual fund index.
Incyte stock ranks seventh in IBD's profitable biotech industry group, according to IBD Stock Checkup. The group lags among IBD's 145 industry groups, holding 109th place.
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