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FDA, Sarepta

Stocktwits on MSN · 1h

Sarepta Pauses Shipments Of DMD Drug Elevidys Amid FDA Label Review, Stock Tumbles After-Hours

Sarepta Therapeutics shares closed over 5.3% lower on Monday, hitting more than a nine-year low, and fell another 8.5% in after-hours trading after the biotech firm announced a voluntary halt to U.S.

BioPharma Dive · 1h

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.

MarketWatch on MSN · 17h

Sarepta stock extends decline as company declines FDA call to withdraw drug

Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and Drug Administration request to stop selling a drug tied to three deaths.

Fierce Biotech11h

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb girdle ...

2don MSN

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 ...

STAT8hOpinion

The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear

The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

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