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Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...
Sarepta Therapeutics refuses the FDA request to halt its gene therapy shipments following a third patient death, challenging ...
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
Sarepta (SRPT) plans to continue Elevidys shipments for Duchenne muscular dystrophy, despite FDA request not to do so after ...
Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...
The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...
Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a ...
The company had previously halted shipments to certain older patients following the deaths of two teenagers treated with the ...
Sarepta Therapeutics, Inc. ( NASDAQ: SRPT) Strategic Restructure and ELEVIDYS Label Update Conference Call July 16, 2025 4:30 PM ET Douglas S. Ingram - President, CEO & Director Ian Estepan - ...
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