Sarepta Gene Therapy Risks

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Sarepta, FDA and Gene Therapy

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 could still carry major consequences for the Duchenne community.

· 8h

InnovationRx: Sarepta Blinks In Showdown With FDA

· 3d · on MSN

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

· 1d

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

Sarepta Therapeutics was falling again in premarket trading Tuesday as its future looks increasingly shaky after it agreed to halt shipments of its Elevidys drug under pressure from the Food and Drug ...

STAT · 1d

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

STAT · 1d

In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

5don MSN

Sarepta shares plunge 40% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its key gene therapy treatment appeared at risk. The Food and Drug Administration will request that the company voluntarily stop all shipments of the treatment, Elevidys, a person familiar with the matter told CNBC.

Fierce Biotech2d

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 muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.

MedPage Today2d

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 the agency was investigating the three deaths due to acute liver failure following treatment with Sarepta's AAVrh74 gene therapies.