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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.
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
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 ...
Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.
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 Provides Safety Update for ELEVIDYS and Initiates Steps to Strengthen Safety in Non-Ambulatory Individuals with Duchenne Provided by Business Wire Jun 15, 2025, 5:00:00 AM.
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