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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.
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 ...
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Sarepta Therapeutics Stock Plunges On Multiple Downgrades ... - MSN
Shares of Sarepta Therapeutics, Inc. (SRPT) traded 46% lower on Monday morning after multiple analysts downgraded the stock following the death of a second patient during their treatment with the ...
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 ...
Even if the company is able to upgrade the safety protocols around ELEVIDYS, and the FDA doesn’t force a post-marketing withdrawal, these serious adverse events are almost certain to raise ...
Nevertheless, on the same day, Sarepta assured investors that “the benefit-risk of ELEVIDYS remains positive.” Next, on June 15, 2025, Sarepta announced that a second patient treated with ...
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 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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