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Sarepta, FDA and gene therapy

· 14h · on MSN

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the approval of Elevidys, following mounting regulatory scrutiny and two recent patient deaths linked to the company's gene therapy.

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· 13h · on MSN

FDA Investigates Death of Boy Who Got Sarepta’s Gene Therapy

· 3d · on MSN

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Fierce Pharma1d

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

Investor's Business Daily on MSN1d

The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent' For Gene Therapies.

Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...

4d

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

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