Sarepta nevertheless plans to push for full FDA approval of Vyondys 53 and Amondys 45 based on what it said are “encouraging ...
Still, CEO Doug Ingram claimed removing the two drugs, Vyondys 53 and Amondys 45, from market would make “little sense” and ...
Two of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) candidates have failed to reach their primary endpoint in a ...
Sarepta's Duchenne trial missed its main goal but showed trends favoring treatment; Q3 earnings topped estimates amid ...
Vyondys 53 (golodirsen) is a prescription drug used to treat Duchenne muscular dystrophy. The drug comes as a liquid solution that’s typically given once per week by intravenous (IV) infusion. Vyondys ...
On November 3, 2025, Sarepta Therapeutics reported that its Phase 3 ESSENCE trial for Duchenne muscular dystrophy therapies AMONDYS 45 and VYONDYS 53 did not meet the primary endpoint, though ...
Sarepta Therapeutics, Inc. (NASDAQ: SRPT) stock fell sharply Tuesday following disappointing results from a key clinical trial and ongoing concerns about its drug pipeline. However, "Pharma Bro" ...
Vyondys 53 (golodirsen) is a prescription drug used to treat Duchenne muscular dystrophy. Vyondys 53 can cause side effects that range from mild to serious. Examples include headache, fever, and belly ...
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Sarepta Crashes After Two Muscular Dystrophy Drugs Fail Confirmatory Tests
Sarepta stock crashed late Monday after the biotech company said two of its muscular dystrophy drugs failed their ...
In August the FDA was skeptical about Sarepta Therapeutics Inc.’s injectable Vyondys 53 (golodirsen), but that’s changed as the company just received accelerated approval for the Duchenne muscular ...
"While the ESSENCE study did not meet statistical significance on its primary endpoint, we believe the results demonstrated a clear treatment effect, showing clinically meaningful functional outcomes ...
Vyondys 53 (golodirsen) is a brand-name infusion that’s prescribed for Duchenne muscular dystrophy (DMD) in certain adults and children. As with other drugs, Vyondys 53 can cause side effects, such as ...
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