1 hr. ago
The FDA approved Pasatru, whose generic name is garetosmab, of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) for adults with fibrodysplasia ossificans progressiva. FOP is an ultra-rare genetic disorder in which bone forms inside muscles, tendons, and ligaments, progressively restricting movement. In a 56-week Phase 3 trial involving 63 adults, the approved 3-milligram-per-kilogram dose reduced the number of new abnormal bone lesions by 94% compared with placebo. The decision completed an unusual clinical recovery. Regeneron paused an earlier study in 2020 after five patients died during its open-label portion, when all participants were receiving active treatment. The published ****** ysis later considered a relationship to treatment unlikely, although causality could not be ruled out. For Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), Pasatru is a regulatory and scientific victory whose earnings potential is constrained by an exceptionally small market.
The company's existing scale makes that limitation difficult to ignore. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) generated second-quarter revenue of $4.29 billion, up 17%, while company-defined non-GAAP diluted EPS reached $14.29. Global Dupixent sales, recorded by partner Sanofi, increased 38% to approximately $6 billion, and U.S. Eylea HD sales rose 52% to $596 million. Against those franchises, even a successful Pasatru launch would have limited influence on consolidated results.
The approval demonstrates that Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) can recover a program after a major clinical setback. Following the 2020 dosing pause, the company worked with regulators to design a late-stage study that produced a statistically significant reduction in new bone lesions. Pasatru also validates research into Activin A, which activates the mutant ACVR1/ALK2 receptor and triggers abnormal bone formation in FOP.
That platform value may matter more than initial sales. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) plans to begin a pediatric trial later in 2026, which could eventually expand the eligible population. The regulatory recovery may also strengthen confidence in the company's ability to advance other rare-disease programs from internally discovered biology.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is entering an exceptionally small pharmaceutical market. Published prevalence estimates generally range from approximately one case per one million to one per two million people. Only approximately 800 to 900 known or confirmed cases have been identified globally, although additional patients may remain undiagnosed. Pasatru is currently approved only for adults, further narrowing its immediate market.
#regeneron #pasatru #adults #market
The company's existing scale makes that limitation difficult to ignore. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) generated second-quarter revenue of $4.29 billion, up 17%, while company-defined non-GAAP diluted EPS reached $14.29. Global Dupixent sales, recorded by partner Sanofi, increased 38% to approximately $6 billion, and U.S. Eylea HD sales rose 52% to $596 million. Against those franchises, even a successful Pasatru launch would have limited influence on consolidated results.
The approval demonstrates that Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) can recover a program after a major clinical setback. Following the 2020 dosing pause, the company worked with regulators to design a late-stage study that produced a statistically significant reduction in new bone lesions. Pasatru also validates research into Activin A, which activates the mutant ACVR1/ALK2 receptor and triggers abnormal bone formation in FOP.
That platform value may matter more than initial sales. Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) plans to begin a pediatric trial later in 2026, which could eventually expand the eligible population. The regulatory recovery may also strengthen confidence in the company's ability to advance other rare-disease programs from internally discovered biology.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is entering an exceptionally small pharmaceutical market. Published prevalence estimates generally range from approximately one case per one million to one per two million people. Only approximately 800 to 900 known or confirmed cases have been identified globally, although additional patients may remain undiagnosed. Pasatru is currently approved only for adults, further narrowing its immediate market.
#regeneron #pasatru #adults #market
1 month ago
Valued at a market cap of $68.8 billion, Regeneron Pharmaceuticals, Inc. (REGN) is a leading biotechnology company that discovers, develops, and commercializes antibody-based medicines for serious diseases. Headquartered in Tarrytown, New York, the company is known for leveraging its proprietary genetic research and antibody technologies to develop innovative therapies.
REGN is scheduled to announce its fiscal Q2 earnings for 2026 before the market opens on Thursday, July 30. Ahead of the release, **** ysts expect this healthcare company to report a profit of $8 per share, down 25.4% from $10.72 per share in the year-ago quarter. The company has topped Wall Street's bottom-line estimates in each of the last four quarters.
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REGN is scheduled to announce its fiscal Q2 earnings for 2026 before the market opens on Thursday, July 30. Ahead of the release, **** ysts expect this healthcare company to report a profit of $8 per share, down 25.4% from $10.72 per share in the year-ago quarter. The company has topped Wall Street's bottom-line estimates in each of the last four quarters.
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2 months ago
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the 10 Best AI-Powered Healthcare Stocks to Buy According to Hedge Funds.
On June 22, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) said the FDA and the European Medicines Agency accepted regulatory applications for cemdisiran. It is to treat adults with "generalized myasthenia gravis" who are anti-acetylcholine receptor antibody-positive.
The company said the FDA granted "Priority Review" for the new drug application and set a target action date in November 2026 after the use of a priority review voucher. The biotech firm also expects a European Commission decision in the second half of 2027. The filings are supported by data from the Phase 3 NIMBLE trial ****** sing subcutaneous cemdisiran dosed every 12 weeks in adults with symptomatic gMG.
On the same day, RBC Capital maintained a "Sector Perform" rating and a $707 price target on Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN). However, the firm called AbbVie's acquisition of Apogee Therapeutics a "net negative" for the company. RBC Capital said the deal adds fuel to a potential next-generation competitor to Dupixent. It also adds AbbVie's commercial expertise and longstanding dermatology market relationships behind Apogee's IL-13 antibody program.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is a biotechnology firm. Its brand lineup includes Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara.
On June 22, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) said the FDA and the European Medicines Agency accepted regulatory applications for cemdisiran. It is to treat adults with "generalized myasthenia gravis" who are anti-acetylcholine receptor antibody-positive.
The company said the FDA granted "Priority Review" for the new drug application and set a target action date in November 2026 after the use of a priority review voucher. The biotech firm also expects a European Commission decision in the second half of 2027. The filings are supported by data from the Phase 3 NIMBLE trial ****** sing subcutaneous cemdisiran dosed every 12 weeks in adults with symptomatic gMG.
On the same day, RBC Capital maintained a "Sector Perform" rating and a $707 price target on Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN). However, the firm called AbbVie's acquisition of Apogee Therapeutics a "net negative" for the company. RBC Capital said the deal adds fuel to a potential next-generation competitor to Dupixent. It also adds AbbVie's commercial expertise and longstanding dermatology market relationships behind Apogee's IL-13 antibody program.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is a biotechnology firm. Its brand lineup includes Dupixent, Evkeeza, Eylea, Inmazeb, and Kevzara.
2 months ago
Pharmaceutical giant AbbVie (NYSE: ABBV) made a bold move this past Monday when it announced its planned $10.9 billion acquisition of Apogee Therapeutics (NASDAQ: APGE).
The deal would bring a promising immunology drug, zumilokibart, into AbbVie's pipeline. This is a drug that many see as competing with Dupixent from Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) as a treatment for moderate to severe atopic dermatitis, the most common form of eczema.
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AbbVie said it would pay $135.11 a share in cash, a 49% premium to Apogee's closing price last week of $90.38. Here are two reasons to buy AbbVie stock if the deal goes through, and one reason to stand on the sidelines.
Immunology is AbbVie's primary core competency. While the pharmaceutical company has successfully transitioned patients from Humira to its newer blockbusters, Skyrizi and Rinvoq, the Apogee acquisition provides immediate entry into next-generation targets. Apogee's lead **** et, zumilokibart, directly targets interleukin-13 (IL-13). This allows AbbVie to build a powerful clinical footprint in massive, high-margin indications such as atopic dermatitis and asthma, directly positioning it to challenge dominant market players.
The deal would bring a promising immunology drug, zumilokibart, into AbbVie's pipeline. This is a drug that many see as competing with Dupixent from Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) as a treatment for moderate to severe atopic dermatitis, the most common form of eczema.
Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue »
AbbVie said it would pay $135.11 a share in cash, a 49% premium to Apogee's closing price last week of $90.38. Here are two reasons to buy AbbVie stock if the deal goes through, and one reason to stand on the sidelines.
Immunology is AbbVie's primary core competency. While the pharmaceutical company has successfully transitioned patients from Humira to its newer blockbusters, Skyrizi and Rinvoq, the Apogee acquisition provides immediate entry into next-generation targets. Apogee's lead **** et, zumilokibart, directly targets interleukin-13 (IL-13). This allows AbbVie to build a powerful clinical footprint in massive, high-margin indications such as atopic dermatitis and asthma, directly positioning it to challenge dominant market players.
3 months ago
Tarrytown, New York-based Regeneron Pharmaceuticals, Inc. (REGN) discovers, invents, develops, manufactures, and commercializes medicines to treat various diseases worldwide. The company has a market capitalization of $65 billion and develops product candidates to treat eye, allergic and inflammatory, cardiovascular, metabolic, neurological, infectious, and rare diseases, as well as cancer and more.
Companies with a market cap of $10 billion or more are typically referred to as “big-cap stocks.” REGN fits squarely into that category, with its market cap exceeding this threshold and reflecting its substantial size and influence in the biotechnology industry.
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Companies with a market cap of $10 billion or more are typically referred to as “big-cap stocks.” REGN fits squarely into that category, with its market cap exceeding this threshold and reflecting its substantial size and influence in the biotechnology industry.
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