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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Exclusive: 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,

The Associated Press on MSN · 7h

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.

Seeking Alpha on MSN · 12h

Sarepta to continue Elevidys shipments despite FDA request to halt

Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after patient deaths. Read more here.

Patient dies in Sarepta gene therapy trial, adding to safety concerns

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...

23h

Sarepta Therapeutics Provides Statement on ELEVIDYS

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

Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

Sarepta Therapeutics crisis is huge blow to Duchenne families, company

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...

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