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 shook the biopharmaceutical industry over the weekend, with the repercussions of the CBER leadership change rattling drug and vaccine maker stocks on 31 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. The closely watched fund is a barometer of industry health that has been dropping since President Donald Trump’s inauguration due to a variety of issues, including double-digit tariffs on products manufactured outside the US
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