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Sarepta Suspends Elevidys Shipments After Second Liver Failure Death

The company is enhancing immunosuppressive regimens to address emerging safety signals in its Duchenne muscular dystrophy gene therapy

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Overview

  • Shipments of Elevidys have been halted for non-ambulatory Duchenne muscular dystrophy patients pending approval of enhanced immunosuppression protocols.
  • Dosing in a related Elevidys clinical trial has been paused to investigate safety and implement mitigation measures.
  • Sarepta’s stock plunged nearly 40% in premarket trading following the company’s safety disclosures.
  • Analysts at Piper Sandler and BMO Capital downgraded their ratings on Sarepta’s shares, citing heightened safety concerns.
  • Elevidys generated $820.8 million in revenue in 2024 and was projected to bring in $1.5 billion in 2025, putting future earnings forecasts at risk.