Sarepta Gene Therapy Risks

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Sarepta Therapeutics, FDA

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

U.S. regulators recently asked Sarepta Therapeutics to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died...

· 2d · on MSN

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

Managed Healthcare Executive · 10h

Sarepta to Pause Shipments of the Gene Therapy Elevidys

· 7h

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following s...

· 10h

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

STAT · 13h

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

4don 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.

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.

BioPharma Dive1d

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 the FDA.

Fierce Biotech1d

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.

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.