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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.
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.
Sarepta is temporarily suspending shipments of Elevidys for non-ambulatory patients while an enhanced immunosuppressive regimen is evaluated, discussed with regulatory bodies, and put in place.
Sarepta Therapeutics' Elevidys Liver Deaths Trigger Selloff, A Contrarian Opportunity Jun. 16, 2025 9:00 AM ET Sarepta Therapeutics, Inc. (SRPT) Stock SRPT 26 Comments ...
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 (NASDAQ:SRPT) fell ~38% in the premarket on Monday after the company reported a second fatality from acute liver failure in a patient treated with Elevidys, a gene therapy ...
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