News

MedPage Today5h
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
Sarepta refuses to pull gene therapy despite FDA order
Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the ...
BioPharma Dive2h
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
Fierce Biotech6h
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...
Sarepta Therapeutics: Why Is SRPT Stock Crashing?
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Sarepta Stock Continues to Fall After Patient Death Linked to Investigational Gene Therapy
Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...
STAT3hOpinion
The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear
The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...
InvestorsHub on MSN7h
Sarepta Shares Drop as FDA Suspends Gene Therapy Trials for Muscular Dystrophy
Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...
Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug
Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...
Investing.com India3h
Sarepta shares hit as Mizuho, Leerink warn on FDA rift, credibility risk
Investing.com -- Sarepta Therapeutics came under pressure after two brokerages slashed their price targets and downgraded the stock, flagging mounting safety, regulatory, and credibility concerns ...