ELEVIDYS Shipment Halt

News

FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

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 · 3h

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.

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

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

18m

Sarepta Stock Keeps Sliding as Company Rejects FDA Call to Withdraw Drug

Sarepta Therapeutics has rejected a call by the Food and Drug Administration to stop shipments of its muscular dystrophy drug ...

11hon MSN

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

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

STAT14h

Pharmalittle: We’re reading about Sarepta resisting FDA over Elevidys, agency naming top drug regulator, and more

She does not take orders, but if you’re really, really nice to a certain STAT reporter…) Anyway, onto the news ,,, Sarepta Therapeutics refused a U.S. Food and Drug Administration request to halt ...

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