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FDA mulls Elevidys market withdrawal following 3rd death after a Sarepta gene therapy
Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger misgivings about the approved drug in the wake of the death of a third patient who received one of the company's gene therapies.
Wall Street analysts were quick to downgrade Sarepta Therapeutics (NASDAQ:SRPT) on Monday as the company suspended its revenue guidance for 2025 following a second fatality linked to Elevidys, its ...
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 ...
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 Therapeutics' Elevidys Liver Deaths Trigger Selloff, A Contrarian Opportunity Jun. 16, 2025 9:00 AM ET Sarepta Therapeutics, Inc. (SRPT) Stock SRPT 26 Comments ...
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...
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.
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