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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 ...

Exclusive: US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

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 ...

Exclusive-US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...

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

The FDA called for Sarepta Therapeutics to stop shipping its muscular dystrophy gene therapy, but the company said no.

Sarepta slides as FDA places clinical hold on gene therapy clinical trials

Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform 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 ...

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 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 ...
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StockWatch: Sarepta Shares Nosedive after LGMD Gene Therapy Patient Dies

The death of a third patient tied to a Sarepta Therapeutics gene therapy this year sent the company’s shares nosediving 36% ...