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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 ...
Chemistry World3d

Sarepta gene therapy deaths highlight tragic rare disease dilemma

Regulators block Duchenne muscular dystrophy treatment after fatal side-effects outweigh questionable efficacy ...
Fierce Biotech12d

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 slides as FDA places clinical hold on gene therapy clinical trials

Sarepta Therapeutics (NASDAQ:SRPT) fell 11% premarket on Monday after announcing the U.S. FDA has placed a clinical hold on its investigational gene therapy trials for limb girdle muscular dystrophy ...
BioPharma Dive12d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
Devdiscourse11d

Sarepta Suspends Gene Therapy Shipments After Tragic Deaths

Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
Fierce Pharma2d

Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Clinical Trials Arena on MSN11d

Sarepta refuses to pull gene therapy despite FDA request

Sarepta Therapeutics is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.
MedPage Today12d

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 ...

FDA Places Sarepta's Investigational Gene-Therapy Trials on Hold Following Patient Death

Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.