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FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Wall Street analysts were quick to downgrade Sarepta Therapeutics (NASDAQ:SRPT) on Monday as the company suspended its revenue guidance for 2025 following a second fatality linked to Elevidys, its ...
Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...
Sarepta shares fell ~40% in premarket after reporting a second patient death linked to Elevidys. Sarepta halted Elevidys shipments for non-ambulatory patients and paused dosing in the ENVISION ...
Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug died. The patient was being treated for Duchenne muscular dystrophy, and ...
Following a second patient death, Sarepta is temporarily suspending use of Elevidys in non-ambulatory DMD patients, pending evaluation of an enhanced immunosuppression regimen.
This established skepticism from Dr. Prasad, even prior to the recent reports of liver failure deaths, suggests a likely reluctance to support Sarepta’s continued marketing of Elevidys.
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