ELEVIDYS Shipment Halt

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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.

· 1d · on MSN

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

· 22h · on MSN

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

· 1d

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...

· 1d

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

· 2d

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

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.

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Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

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: