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FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.
Sarepta halted Elevidys shipments for non-ambulatory patients and paused dosing in the ENVISION trial. Get special access to three exclusive "Top 10 Stocks" power lists today, updated daily.
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 ...
A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy (DMD) gene therapy’s safety profile. Sarepta and ...
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 ...
ELEVIDYS Impact. Sarepta’s decision to stop shipping ELEVIDYS to treat non-ambulatory DMD patients could eliminate roughly 65% of the potential patient population. ... (anti-rejection graft ...
Sarepta reports a second fatal case of acute liver failure linked to Elevidys. Analyst cuts Sarepta’s rating due to uncertain safety and future revenue potential. A new wave of value and ...
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