SRPT Stock Up 8% on Positive Long-Term Data From Elevidys Study in DMD

Sarepta Therapeutics SRPT announced positive three-year top-line data from Part 1 of the phase III EMBARK study, evaluating Elevidys in ambulatory individuals with Duchenne muscular dystrophy (DMD) aged 4 to 7 years at the time of dosing.

Sarepta’s Elevidys is the only approved gene therapy for treating DMD.

The three-year data showed that Elevidys slowed disease progression and achieved sustained improvements in patients' ability to control and coordinate movement three years after treatment.

SRPT shares rose nearly 8% on Monday in response to the top-line data.

Over the past year, Sarepta Therapeutics’ shares have declined 80.5% against the industry’s 17.2% rise.

Details From SRPT’s Phase III EMBARK Study

Data from Part 1 of the global, randomized phase III EMBARK study demonstrated that treatment with Elevidys led to statistically significant and clinically meaningful improvements across all major functional endpoints compared with a pre-specified propensity-weighted external control group of untreated patients.

Approximately 52 patients treated with Elevidys maintained higher motor function three years post- infusion, with North Star Ambulatory Assessment (NSAA) scores remaining above baseline. In contrast the external control group exhibited a typical age-related decline.

NSAA is a scale used to measure functional motor abilities in ambulant children with DMD.

Additionally, Elevidys slowed disease progression by 73%, as measured by time to rise (TTR) and by 70% as measured by 10-meter walk run (10MWR) compared with the external control group.

TTR measures time to rise from the floor, while 10MWR observes the time to complete a 10-meter walk or run.

No new safety signals were observed in these ambulatory patients over the three-year period.

At the time of their most recent assessment, patients had a mean age of nine years, a stage typically associated with consistent functional decline in DMD.

More on Elevidys

Elevidys, a single-dose intravenous gene therapy was approved by the FDA in June 2023 as the first and only gene therapy to treat DMD.

The company has partnered with Roche to market the therapy outside the United States.

In 2025, Sarepta voluntarily paused shipments of Elevidys to non-ambulatory patients in the United States after two non-ambulatory boys with DMD died of acute liver failure following treatment with Elevidys.

In response, the FDA made significant changes to the therapy’s label, including narrowing the use to ambulatory DMD patients and boxed warnings for severe liver risks. The therapy was no longer authorized for use in non-ambulatory patients. Elevidys was also mandated to add limits for liver impairment, recent vaccinations or infections and expand monitoring needs. Before these label updates, Sarepta had voluntarily suspended both clinical and commercial Elevidys dosing for non-ambulatory patients.

In the third quarter of 2025, SRPT generated revenues of $131.5 million from Elevidys compared with $181 million for the same period of 2024. Elevidys’ sales declined due to lower volumes following the suspension.

The latest three-year data shows that treatment with Elevidys can make a meaningful difference over time, which may help improve the drug’s sales in future quarters, which explains the price increase.

Sarepta Therapeutics’ Zacks Rank & Stocks to Consider

SRPT currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Castle Biosciences CSTL, Keros Therapeutics KROS and Alkermes ALKS, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 5 cents. CSTL shares have risen 59% over the past year.

Castle Biosciences’ earnings beat estimates in three quarters, and missed in the remaining quarter, with the average surprise being 66.11%.

Over the past 60 days, 2026 loss per share estimates for Keros Therapeutics have narrowed from $3.56 to $3.36. KROS shares have surged 65.9% over the past year.

Keros Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 9098.63%.

Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS shares have risen 5.9% over the past year.

Alkermes’ earnings beat estimates in three quarters and missed in the remaining quarter, with the average earnings surprise being 4.58%.

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