Sarepta Therapeutics Temporarily Halts Three Clinical Studies Of Elevidys: Retail Is Dull While Stock Drops

Shares of Sarepta Therapeutics, Inc. (SRPT) traded over 2% lower in afternoon trade on Friday after the company said it has temporarily halted recruitment and dosing in three clinical studies of its gene therapy ELEVIDYS.

ELEVIDYS is a one-time gene therapy for Duchenne muscular dystrophy (DMD). It uses an adeno-associated virus (AAV) to deliver a modified gene that helps produce micro-dystrophin, a protein missing due to mutations in the DMD gene. The treatment is given through an intravenous infusion to target skeletal muscle.

The company said that monitoring and data collection for participants already enrolled in the three clinical studies continues.

Sarepta added that it does not anticipate the halt to impact the timeline of these studies materially.

The halt comes after Sarepta disclosed on March 18 that a young man with Duchenne muscular dystrophy passed away following treatment with ELEVIDYS, having suffered acute liver failure (ALF).

While ALF is a known possible side effect of ELEVIDYS, an acute liver failure leading to death represents a severity of injury not previously reported for the gene therapy, the company said at the time.  

On Friday, Sarepta said that European Union (EU) reference member country authorities had requested an independent data monitoring committee (DMC), which met earlier this week.

According to the company, the DMC concurred that the “overall benefit-risk profile remains favorable to continue dosing in the paused clinical trials without changes to the study protocols.”

The company plans to submit this information to EU regulators within a week, and the subsequent decision to lift the temporary halt will follow the EU regulatory process, it said.

On Stocktwits, retail sentiment around Sarepta remained unmoved within ‘bearish’ territory, accompanied by ‘low’ levels of chatter over the past 24 hours.

SRPT's Sentiment Meter and Message Volume as of 1:20 p.m. ET on April 4, 2025 | Source: Stocktwits

H.C. Wainwright told investors in a research note that the clinical hold on key Elevidys trials in Europe heightens the uncertainty around the future of the franchise, according to TheFly. The brokerage, however, reiterated a ‘Neutral’ rating on Sarepta with a $75 price target.

Sarepta shares have more than halved in value over the past 12 months.

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