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13h ago

Sarepta Therapeutics Cuts One-Third of Workforce and Pivots to siRNA After Safety Setbacks

The FDA has required a black box warning for Elevidys to highlight acute liver risks.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Sarepta Therapeutics faces renewed scrutiny as safety concerns mount around its gene therapy program.
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Overview

  • Sarepta eliminated approximately 500 jobs, or 36% of its staff, under a strategic restructuring plan.
  • The company is redirecting its R&D efforts toward five rare disease treatments on its siRNA platform and pausing select gene therapy programs.
  • The overhaul follows the March and June deaths of Duchenne patients from acute liver failure linked to Elevidys.
  • Sarepta expects to achieve $100 million in cost savings by the end of 2025 and about $400 million in annual savings starting in 2026.
  • Preliminary second-quarter net product revenue reached $513 million, including $282 million from Elevidys, and shares jumped around 35–40% after the announcement.