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Peter Marks’ Departure From FDA Rattles Biopharma Industry

XBI Reaches A New 2025 Low

 
• By Mandy Jackson

Stock prices plummeted, particularly for vaccine makers and cell and gene therapy developers, after the US FDA’s top biologics overseer resigned over vaccine misinformation concerns.

FDA review of vaccines and cell and gene therapies could be held up under new CBER leadership (Shutterstock)
Key Takeaways
  • The resignation of CBER director Peter Marks hit biopharma stocks hard as the FDA leadership shakeup increased regulatory uncertainty, particularly for vaccines and cell and gene therapies.
  • Marks, a proponent of fast-tracking novel medicines and rare disease treatments, was seen as a cell and gene therapy champion, so companies in that space traded lower based on his departure.
  • HHS Secretary Robert F. Kennedy Jr.’s vaccine skepticism prompted Marks’ resignation and raised concerns about the future of novel vaccines under the Trump Administration’s FDA.

News that US Food and Drug Administration Center for Biologics Evaluation and Research (CBER) director Peter Marks submitted his resignation, effective 5 April, late in the day on 28 March...

The XBI fund closed down 3.9% on 31 March – its heaviest day of trading so far this year – after falling by more than 5% earlier in the day....

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