Nicole Verdun, director of the office that reviews cell and gene therapies at the FDA, and her deputy Rachael Anatol have been placed on administrative leave and escorted out of the agency, STAT’s Jason Mast and Adam Feuerstein report, citing a recording of the meeting. Verdun had worked closely with Peter Marks, the former head of the Center for Biologics Evaluation and Research, on establishing new paths for bringing gene therapies to market, particularly in rare diseases. Verdun was the FDA’s key overseer of Capricor’s application for approval of its deramiocel drug. Shares of Capricor Therapeutics (CAPR) are down 5% in premarket trading.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 55% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on CAPR:
- Capricor Therapeutics announces ODD to Deramiocel
- Capricor treatment of Becker muscular dystrophy granted orphan designation
- Roth thinks Capricor Therapeutics drug could still be approved by August 31
- Adobe reports Q2 beat, Meta invests in Scale AI: Morning Buzz
- H.C. Wainwright cautions Capricor investors to ‘calm down’ after FDA letter