Sarepta Rejects FDA Withdrawal

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FDA, Sarepta and Elevidys

Sarepta drops as report suggests FDA needs new trials for Elevidys

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its gene therapy, Elevidys. Read more here.

BioPharma Dive · 5d

Sarepta stops Elevidys shipments after standoff with FDA

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" with the regulator.

Benzinga · 5d

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 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.

Fierce Pharma8d

FDA mulls Elevidys market withdrawal following 3rd death after a Sarepta gene therapy

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

Hosted on MSN1mon

Sarepta Stock Slumps After FDA Opens Probe Into Patient Death ... - MSN

H.C. Wainwright reiterated a ‘Sell’ rating on Sarepta on Wednesday with a $10 price target. The firm views the FDA as a potential headwind for Sarepta now.

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 ...

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.

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