Sarepta Rejects FDA Withdrawal

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FDA, Sarepta and Elevidys

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· 2d · on MSN

Sarepta drops as report suggests FDA needs new trials for Elevidys

In essence, this is a real time safety test for FDA and all to consider.

BioPharma Dive · 4d

Sarepta stops Elevidys shipments after standoff with FDA

· 5d

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

· 8h

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics ( NASDAQ: SRPT) have drawn regulatory scrutiny on the viral vector used in the company’s gene therapy platform tech...

STAT · 1d

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

· 1d

EU panel declines backing Sarepta-Roche gene therapy for Duchenne

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.

FiercePharma1mon

FDA investigates patient deaths after treatment with Sarepta's Duchenne ...

Sarepta noted that the FDA had proactively asked if the company has considered using additional immunosuppression, ... A full market withdrawal is not out of the question, though.

Reuters1mon

Sarepta shares crash as second patient dies after receiving its gene ...

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

The Business Journals1mon

FDA says it's investigating Sarepta’s Duchenne patient deaths

The Food and Drug Administration is conducting an investigation following the deaths of two patients treated with Sarepta's gene therapy for Duchenne muscular dystrophy. Thursday, July 31, 2025 ...

Hosted on MSN1mon

FDA investigates patient deaths after treatment with Sarepta's ... - MSN

Sarepta said in an email to Reuters, "The FDA communication was triggered by our report to the FDA and our suggested update to the label to include information relating to the recent events."

Reuters1mon

FDA investigates patient deaths after treatment with Sarepta's gene ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...