FDA Halts Sarepta Shipments

News

Gene Therapy Stays on Market Despite FDA Request

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

Reuters on MSN · 2d

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

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

Benzinga · 2h

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.

3hon MSN

Sarepta extends losses premarket after refusing FDA’s halt request

Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...

Yahoo Finance4h

Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug

BioCentury first reported the patient death, which then prompted the FDA to request Sarepta to halt shipments of Elevidys, its Duchenne muscular dystrophy drug. Sarepta refused. That ...

49m

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

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