What challenges has Sarepta's Elevidys faced recently?

Elevidys faced infusion delays due to a severe flu season in late 2025 and was briefly pulled from the market earlier due to patient deaths.

Will Sarepta's older Duchenne drugs be removed from the market?

The US FDA may remove Sarepta's older drugs, Amondys 45 and Vyondys 53, following trial results that failed to confirm their benefits.

Who are Sarepta's main competitors in Duchenne treatment?

Solid Biosciences Inc. and RegenxBio are developing next-generation treatments that could challenge Sarepta's current dominance in the Duchenne market.

Home / Business and Economy / Sarepta Recovers: Gene Therapy Battles Setbacks

Sarepta Recovers: Gene Therapy Battles Setbacks

13 Jan

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Summary

Elevidys infusions rescheduled due to a severe flu season in late 2025.
Sarepta faces potential FDA removal of two older Duchenne drugs.
New competitors emerge, threatening Sarepta's market dominance.

Sarepta Recovers: Gene Therapy Battles Setbacks

Sarepta Therapeutics is working to rebound after a challenging period that saw its gene therapy Elevidys, used for Duchenne muscular dystrophy, briefly withdrawn from the market. The company cited a severe flu season at the end of 2025, which necessitated rescheduling infusions for six patients and potentially impacted its current year's financial guidance, suggesting possible uncertainty in drug uptake. This follows a tumultuous year where two teenagers died, leading to the temporary market pull.

Further complicating matters, a recent trial failed to confirm the benefits of two of Sarepta's established drugs, Amondys 45 and Vyondys 53. This development has raised the possibility of their removal from the market by the US Food and Drug Administration. Sarepta has announced plans to meet with US regulators by the end of the current quarter to discuss the future of these exon-skipping treatments.