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Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.
FDA permits use of Sarepta Therapeutics’ Duchenne therapy in younger patients after short-lived halt
The FDA said it was clearing the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular ...
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
Sarepta Therapeutics’ stock was soaring Tuesday after the FDA recommended lifting the pause on the company’s Duchenne ...
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 ...
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Zacks Investment Research on MSNSarepta to Report Q2 Earnings: What's in Store for the Stock?
We expect Sarepta Therapeutics SRPT to report second-quarter 2025 earnings on Aug. 6, after market close. The company’s ...
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular dystrophy over safety issues, even as patients and investors expressed ...
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