Why Did SRPT Stock Rise 6% In Pre-Market Today?

The company announced positive three-year topline results from its EMBARK study evaluating ELEVIDYS, a gene therapy for ambulatory patients with DMD.

• The data showed that patients treated with ELEVIDYS experienced a significant and durable slowing of disease progression compared with an external control group.
• ELEVIDYS reduced the rate of functional decline by about 70%.
• ELEVIDYS has been administered to more than 1,200 patients worldwide in both clinical trials and real-world use.

Shares of Sarepta Therapeutics (SRPT) jumped 6% in pre-market trading on Monday after the company announced positive three-year topline results from its Phase 3 EMBARK study evaluating ELEVIDYS, a gene therapy for ambulatory patients with Duchenne Muscular Dystrophy (DMD).

SRPT shares gained further after the opening bell, trading 12% higher at the time of writing.

The data showed that patients treated with ELEVIDYS experienced a significant and durable slowing of disease progression compared with an external control group. Three years after treatment, patients maintained North Star Ambulatory Assessment (NSAA) scores above baseline, while untreated patients showed the expected decline.

ELEVIDYS reduced the rate of functional decline by about 70% or more on key measures, including Time to Rise and the 10-meter walk/run, with the treatment effect increasing over time. No new safety concerns were identified, supporting ELEVIDYS’ manageable safety profile.

Sarepta said analysis of its three-year data is ongoing and includes functional results from patients who crossed over to treatment and have now been followed for two years. 

ELEVIDYS is currently the only approved gene therapy for DMD and has been given to more than 1,200 patients worldwide in both clinical trials and real-world use. The therapy is available for ambulatory patients aged four and older under an updated FDA label announced in late 2025. 

Latest Updates

Sarepta is working with Roche to broaden global access to the therapy, with Sarepta handling U.S. regulatory approval, manufacturing, and commercialization, and Roche managing approvals and distribution outside the United States.

Earlier this month, the company announced the submission of a clinical trial application to New Zealand’s Medsafe for its INSIGHTT study of SRP-1005, an investigational small interfering RNA (siRNA) therapy for Huntington’s disease. If approved, the first-in-human trial is expected to begin in the second quarter of 2026.

Retail Reaction

Retail sentiment on Stocktwits turned ‘extremely bullish’ from ‘bullish’ amid ‘extremely high’ message volumes. SRPT was among the top trending tickers on the platform at the time of writing.

One bullish user said the ‘results are very impressive for a rare disease with no cure’.

Another user added that breaking the $25 resistance mark would be huge. The stock is currently trading around $23.5.

The stock has been under heavy selling pressure over the past year, declining more than 80%.

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