In March, Sarepta Therapeutics, Inc. SRPT shared an replace on Elevidys (delandistrogene moxeparvovec-rokl), the one authorized gene remedy in sufferers with Duchenne muscular dystrophy.
The corporate reported a affected person dying following remedy with Elevidys, having suffered acute liver failure.
Acute liver harm is a identified attainable aspect impact of Elevidys and different AAV-mediated gene therapies and is highlighted within the prescribing info.
On Wednesday, Sarepta and Roche Holdings AG RHHBY quickly halted a number of scientific research.
Additionally Learn: Sarepta Therapeutics’ Duchenne Gene Remedy Exhibits Sustained Advantages And Illness Stabilization At Two Years
Roche, the corporate to which the remedy is licensed exterior the US, has mentioned that this was on the European Medicines Company’s (EMA) request.
The businesses have a therapeutic scientific maintain on Examine 104, Examine 302, and Examine 303 within the EU till the evaluation of the reason for dying is full.
Roche can be pausing the enrollment and dosing of contributors within the U.Ok. for its ENVOL examine.
Affected person security monitoring for already enrolled contributors and ongoing assortment of knowledge will proceed.
In June 2024, the EMA validated and initiated a evaluate of the advertising and marketing authorization utility for Elevidys, a gene remedy for ambulatory sufferers aged 3-7 years outdated with Duchenne muscular dystrophy.
HC Wainwright upgraded Sarepta on Wednesday from Promote to Impartial, saying it’s buying and selling inside a good vary.
Analyst Mitchell S. Kapoor nonetheless anticipates Elevidys income will fall brief within the second half of 2025—particularly after the latest affected person dying as a result of acute liver harm.
Kapoor sees a danger that Elevidys gross sales could decline quicker than anticipated, presumably as early as Q2 2025, as a result of rising hesitation from medical doctors and sufferers relating to its security. The remedy’s restricted effectiveness heightens this concern.
The analyst maintains the worth forecast of $75 per share.
Needham maintained Sarepta Therapeutics with a Purchase, decreasing the worth forecast from $202 to $183.
Value Motion: SRPT inventory is down 6.68% at $58.30 on the final test Thursday.
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