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Sarepta, gene therapy and FDA

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.

Bloomberg on MSN · 13h

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

US regulators said they are investigating the death of an 8-year-old boy who received a gene therapy from Sarepta Therapeutics Inc.

Associated Press News on MSN · 6d

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.

Medscape37m

EMA Says No to Duchenne Gene Therapy Elevidys

The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.

STAT3d

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

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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