Still, CEO Doug Ingram claimed removing the two drugs, Vyondys 53 and Amondys 45, from market would make “little sense” and ...

"Two of Sarepta’s DMD drugs fail to meet primary endpoint in confirmatory trial" was originally created and published by ...

Sarepta nevertheless plans to push for full FDA approval of Vyondys 53 and Amondys 45 based on what it said are “encouraging ...

Sarepta's Duchenne trial missed its main goal but showed trends favoring treatment; Q3 earnings topped estimates amid ...

Sarepta stock crashed Tuesday after the biotech company said two of its muscular dystrophy drugs failed confirmatory tests.

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 ...

Casimersen 50mg/mL; soln for IV infusion after dilution; preservative-free. Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in original carton until ready for use to protect from light.

Sarepta Therapeutics Inc. shares plunged after a trial designed to confirm the benefits of two of its older drugs failed to show clear patient improvement, raising questions about their future.

Shares of Sarepta Therapeutics Inc. plunged in extended trading Monday after the biotechnology company disclosed ...

-- Commercial distribution of AMONDYS 45 in the U.S. will commence immediately -- -- Information for patients and clinicians is available at www.SareptAssist.com-- CAMBRIDGE, Mass., Feb. 25, 2021 ...

AMONDYS 45 Treatment with casimersen led to a statistically significant increase in dystrophin production in skeletal muscle from baseline to week 48. The Food and Drug Administration (FDA) has ...

NEW YORK, Feb. 25, 2021 /PRNewswire/ -- The Muscular Dystrophy Association (MDA) today celebrated the decision by the US Food and Drug Administration (FDA) to grant accelerated marketing approval to ...