Zinger Key Points
- Sarepta and Roche paused multiple Elevidys trials in the EU at the EMA’s request.
- HC Wainwright upgraded Sarepta to Neutral but sees Elevidys sales falling by Q2 2025.
- Today's manic market swings are creating the perfect setup for Matt’s next volatility trade. Get his next trade alert for free, right here.
In March, Sarepta Therapeutics, Inc. SRPT shared an update on Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy.
The company reported a patient death following treatment with Elevidys, having suffered acute liver failure.
Acute liver injury is a known possible side effect of Elevidys and other AAV-mediated gene therapies and is highlighted in the prescribing information.
On Wednesday, Sarepta and Roche Holdings AG RHHBY temporarily halted several clinical studies.
Roche, the company to which the treatment is licensed outside the US, has said that this was at the European Medicines Agency’s (EMA) request.
The companies have a therapeutic clinical hold on Study 104, Study 302, and Study 303 in the EU until the analysis of the cause of death is complete.
Roche is also pausing the enrollment and dosing of participants in the U.K. for its ENVOL study.
Patient safety monitoring for already enrolled participants and ongoing collection of data will continue.
In June 2024, the EMA validated and initiated a review of the marketing authorization application for Elevidys, a gene therapy for ambulatory patients aged 3-7 years old with Duchenne muscular dystrophy.
HC Wainwright upgraded Sarepta on Wednesday from Sell to Neutral, saying it is trading within a fair range.
Analyst Mitchell S. Kapoor still anticipates Elevidys revenue will fall short in the second half of 2025—especially after the recent patient death due to acute liver injury.
Kapoor sees a risk that Elevidys sales may decline faster than expected, possibly as early as Q2 2025, due to growing hesitation from doctors and patients regarding its safety. The treatment’s limited effectiveness heightens this concern.
The analyst maintains the price forecast of $75 per share.
Needham maintained Sarepta Therapeutics with a Buy, lowering the price forecast from $202 to $183.
Price Action: SRPT stock is down 6.68% at $58.30 at the last check Thursday.
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Image via Sarepta Therapeutics
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