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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.
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 ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
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Sarepta Therapeutics Stock Plunges On Multiple Downgrades ... - MSNShares 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 ...
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 ...
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 ...
Investor Contact: Ian Estepan 617-274-4052 iestepan@sarepta.com Media Contacts: Tracy Sorrentino 617-301-8566 tsorrentino@sarepta.com Kara Hoeger 617-710-3898 KHoeger@sarepta.com ...
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 ...
Following Wednesday's update, Sarepta's stock price surged more than 30% during postmarket trading. For investors, the Elevidys black box warning avoided the worst-case scenario: market ...
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