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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.
Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
But uncertainty remains around the FDA's decision-making and whether patient demand for Elevidys will remain, the analysts said. The company voluntarily paused Elevidys shipments for ambulatory patients last week after previously rejecting the FDA's request that it do so.
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
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 ...
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 ...
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 ...
Following a second patient death, Sarepta is temporarily suspending use of Elevidys in non-ambulatory DMD patients, pending evaluation of an enhanced immunosuppression regimen.
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 ...
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