Biotech stocks plunge and industry figures left to wonder after Prasad’s FDA appointment

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Biotech Stocks Plunge After Vinay Prasad’s Appointment as FDA Biologics Chief Sparks Industry Concern

Vinay Prasad, MD, MPH, has been appointed as director of the FDA’s Center for Biologics Evaluation and Research (CBER), succeeding Peter Marks1 3.
Prasad’s reputation for scientific rigor, independence, and public criticism of past FDA decisions has led to widespread industry speculation about stricter regulatory oversight and higher approval thresholds1 3 5.
Following the announcement, the XBI biotech ETF dropped more than 6% in a single day, with some gene and cell therapy companies seeing stock prices fall by up to 30%1 3 5.
The sharp market drop reflects investor fears of slower or more challenging approval pathways for new biologics, particularly affecting developers of gene and cell therapies1 5.
Industry figures have expressed uncertainty and concern regarding how Prasad’s leadership might alter the FDA’s approach to novel treatments and approvals in the future3 5.
The FDA Commissioner, Marty Makary, emphasized Prasad’s commitment to scientific rigor and independence from industry influence in announcing the appointment1.
The move comes at a time of broader volatility within biotech markets, compounding concerns around specific companies and the sector as a whole2 4.