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Investing.com -- Capricor Therapeutics Inc (NASDAQ:CAPR) stock tumbled 20.4% following news that two top FDA officials overseeing cell and gene therapies have been placed on administrative leave.
Nicole Verdun, director of the FDA’s office that reviews cell and gene therapies, and her deputy Rachael Anatol were reportedly escorted out of the agency, according to information obtained and reported on by STAT. The development is particularly significant for Capricor as Verdun was the key overseer of the company’s application for approval of its deramiocel drug.
The unexpected leadership change has sparked concerns throughout the biotech industry, with many companies fearing unpredictable regulatory service going forward. Verdun had been widely praised by biotech companies for her work in accelerating approval pathways for rare disease therapies.
This leadership vacuum follows another significant departure at the FDA. Peter Marks, former head of the Center for Biologics Evaluation and Research who worked closely with Verdun on establishing new pathways for gene therapies, was forced out by the Trump administration in March for his role in regulating Covid-19 vaccines.
While analysts anticipate only minor impacts on trial designs in the near term, they suggest there could be stricter post-marketing requirements for cell and gene therapies moving forward. The continuity of leadership at the FDA had previously been viewed as crucial by industry executives, with one gene therapy CEO previously stating to STAT that "having Verdun stay at the FDA is really important."
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