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Sarepta, FDA and gene therapy

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

Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths.

· 1d · on MSN

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

· 4d · on MSN

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

· 23h

Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

Sarepta Therapeutics was falling again in premarket trading Tuesday as its future looks increasingly shaky after it agreed to halt shipments of its Elevidys drug under pressure from the Food and Drug ...

STAT · 1d

In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

STAT · 1d

Pharmalittle: We’re reading about Sarepta resisting FDA over Elevidys, agency naming top drug regulator, and more

BioSpace1h

Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

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

2don MSN

Sarepta extends losses premarket after refusing FDA’s halt request

Sarepta Therapeutics (NASDAQ:SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second session after plunging 36% on Friday. The decline follows the company's refusal to halt all shipments of its Elevidys gene therapy,

STAT4d

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, following two deaths tied to the product.

1don MSN

Sarepta Stock Sinks. How Its Crisis Went From Bad to Worse.

Sarepta stock has tanked. Most investors don’t see the drugmaker’s executive management as credible following the failure to disclose a patient death, a BMO survey suggests.