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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.
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Sarepta downgraded as company suspends guidance after latest Elevidys death Jun. 16, 2025 11:31 AM ET Sarepta Therapeutics, Inc. (SRPT) Stock RHHBY, RHHBF By: Dulan Lokuwithana, SA News Editor 8 ...
Sarepta Therapeutics (NASDAQ: SRPT) shares plunged 42% on Monday, June 16, following reports of a second patient death associated with its Duchenne muscular dystrophy gene therapy, Elevidys. In ...
Sarepta also preliminarily reported $513 million in second-quarter sales, missing projections for $529 million, according to FactSet. Elevidys brought in $282 million, which also lagged calls for ...
Following a second patient death, Sarepta is temporarily suspending use of Elevidys in non-ambulatory DMD patients, pending evaluation of an enhanced immunosuppression regimen.
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