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Sarepta Therapeutics Inc. (NASDAQ:SRPT) shared topline data from the ESSENCE Phase 3 trial of Amondys 45 (casimersen) and Vyondys 53 (golodirsen) compared with placebo in 225 patients aged 6-13 years with Duchenne muscular dystrophy amenable to exon 45 or 53 skipping.
The treatment favored placebo; however, the observed difference of 0.05 steps/second in least-squares means (LSM) did not reach statistical significance (P=0.309) for the primary endpoint, the 4-step ascend velocity at 96 weeks.
Also Read: What’s Going On Sarepta Stock On Wednesday?
The ESSENCE study was conducted over nine years, including the COVID-19 pandemic, which affected study participants and outcomes.
An analysis that excludes data from participants whose double-blind period overlapped with the COVID-19 pandemic (n=57), shows a 30% reduction (LSM 0.11 steps/second, P=0.09) in disease progression over 2 years on the 4-step ascend velocity in non-COVID-impacted treated participants versus placebo (n=168).
Sarepta intends to schedule a meeting with the U.S. Food and Drug Administration (FDA) to discuss the possibility of converting from accelerated to traditional approval.
Concurrently, the company reported a third-quarter adjusted loss of 13 cents per share, beating the consensus loss of 14 cents per share.
Sales reached $399.36 million, beating the consensus of $338.71 million.
Revenues fell from $467.2 million reported a year ago, reflecting lower Elevidys sales due to lower volume following the suspension of shipments to non-ambulatory patients in the U.S. in June 2025.
William Blair views the ESSENCE trial's failure to meet its primary endpoint as a negative development. Despite management's confidence that
Vyondys 53 and Amondys 45 will not lose marketing authorization. Analyst Sami Corwin is more skeptical and suggests investors are also concerned about the future of these two products.
Vyondys 53 sales reached $32.53 million in the third quarter, while Amondys 45 revenues were $79.81 million.
Sarepta guided for flat to slightly down Elevidys infusion volumes in the fourth quarter, citing lingering disruptions from the earlier pause in ambulatory shipments and seasonal headwinds.
Analyst Corwin notes that investors will be hesitant to reenter the stock until the company provides additional Elevidys revenue guidance for the coming quarters.
William Blair reiterates Market Perform rating.
Price Action: SRPT stock is down 33.33% at $16.30 at the last check on Tuesday.
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Posted In: SRPT
