elevidys gene therapy

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FDA to Ask Sarepta to Halt Elevidys Shipments

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 request Sarepta Therapeutics (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reut...

· 2h · on MSN

Gene Therapy Maker Sarepta Tells FDA It Won't Halt Shipments Despite Patient Deaths

· 4h · on MSN

Sarepta to continue Elevidys shipments despite FDA request to halt

· 2h

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

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient r...

· 17h

FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

· 1d

FDA to ask Sarepta to stop shipping Duchenne gene therapy

· 22h

Sarepta Says It Won't Comply With FDA Request to Stop Shipping Gene Therapy Elevidys

Wall Street analysts have said the third death could amplify patient hesitancy to use Elevidys, given both the therapies use the same delivery vehicle known as adeno-associated virus vector.

STAT · 16h

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

· 22h

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

22hon MSN

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, Elevidys, a source familiar with the matter told Reuters on Friday. Shares of the company extended losses and were down nearly 35% in afternoon trading,

16h

Sarepta Therapeutics Provides Statement on ELEVIDYS

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:

2don MSN

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients who were on the medicine.