Sarepta Therapeutics (SRPT) Soars in overnight trading following announcement of Major Restructuring and FDA Update.

by MarketNewsData

Sarepta Therapeutics (SRPT) is trading at $25.10 up +$6.70 (+36.41%) in overnight trading following Major Restructuring and FDA Update news.

  • Major Corporate Restructuring:
    • Sarepta is reducing its workforce by approximately 500 employees, which is about 36% of its total staff.
    • This move is part of a plan to refocus on its core RNA-based therapeutic programs.
    • The company expects this restructuring to result in approximately $400 million in annual cost savings.
  • Key FDA Update on ELEVIDYS Gene Therapy:
    • Sarepta reached an agreement with the FDA to update the label for ELEVIDYS, its treatment for Duchenne muscular dystrophy.
    • The label will now include a boxed warning—the FDA’s most serious alert—for the risk of acute liver injury and failure.
    • Market Impact: While a boxed warning is serious, this announcement removed significant uncertainty for investors regarding the drug’s regulatory future, which was viewed as a positive development.
    • Sarepta is also proposing a new protocol to the FDA to resume treatment for non-ambulatory patients.
  • Strong Preliminary Financials:
    • The company announced preliminary second-quarter revenue that beat expectations.
    • Preliminary net product revenue for ELEVIDYS was approximately $282 million.
    • Preliminary revenue for its RNA-based PMO franchise was approximately $231 million.

The combination of decisive cost-saving measures, regulatory clarity for a key product, and better-than-expected preliminary revenues fueled a significant rally in Sarepta’s share price in the after-hours session. Investors appear to be applauding the company’s proactive steps to navigate its recent challenges and strengthen its long-term strategic and financial foot.

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