Sarepta Therapeutics, Inc. (SRPT) on Monday announced positive topline three-year results from Part 1 of the EMBARK Phase 3 study, evaluating Elevidys in ambulatory patients with Duchenne muscular dystrophy aged four to seven at treatment. Following the news, shares rose more than 7% in pre-market trading.
After three years, patients treated with Elevidys demonstrated statistically significant, clinically meaningful and durable efficacy across all key motor function measures—including the North Star Ambulatory Assessment (NSAA), Time to Rise (TTR), and 10-meter walk/run (10MWR)—compared to an untreated external control group.
The mean NSAA score for the Elevidys-treated group remained above baseline, while the external control group showed the expected age-related decline. Disease progression slowed by 73% on TTR and 70% on 10MWR versus the control group.
Sarepta shares closed at $21.13 on Friday, down 3.03%.
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