Sarepta Will Resume Gene Therapy Shipments After FDA Review of Recent Patient Death
- Sarepta Therapeutics will resume shipping its gene therapy for some patients after a temporary pause requested by regulators.
- The Food and Drug Administration recommended lifting the hold for young patients with Duchenne’s muscular dystrophy who can still walk.
- The FDA determined that an 8-year-old boy's death was unrelated to the therapy.
- Sarepta's therapy is still under scrutiny due to the deaths of two teenage boys related to acute liver injury, a known side effect.
26 Articles
26 Articles
Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault.
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne muscular dystrophy drug, but analysts worry it will take time for patients and doctors to feel safe using it. Article Attribution | Read More at Article Source The post Sarepta finally gets some good news: A patient death wasn’t its DMD drug’s fault. appeared first on RocketNews.

Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy.
Sarepta Therapeutics (SRPT) Tanks 36% After 3rd Patient Death, SRPT Securities Class Action Pending; Investors With Substantial Losses And Persons With Knowledge Encouraged To Contact Hagens Berman
SAN FRANCISCO, July 28, 2025 (GLOBE NEWSWIRE) -- On July 18, 2025, investors saw the price of their shares in Sarepta Therapeutics, Inc. (NASDAQ: SRPT)...
Watch now: Is the Sarepta mess what a politicized FDA looks like?
On Monday afternoon, just a week after getting Sarepta to pull its Duchenne gene therapy from the market and suggesting it would likely never return, the FDA made a shocking reversal and will let the company start treating some patients again. Today on Post-Hoc Live, I spoke with Baird biotech analyst Brian Skorney about what happened, whether we're seeing the consequence of a politically sensitive (or vulnerable) FDA, and what it means for the …
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