Recent administrative leave placements of Nicole Verdun, MD, and deputy Rachael Anatol, PhD, from the FDA’s Office of Therapeutic Products (OTP) have reignited concerns over cell and gene therapy regulatory stability. Verdun had been instrumental in advancing bespoke CRISPR-based in vivo gene editing therapies, including the landmark treatment curing 'Baby KJ' of a rare disorder. The personnel changes, following leadership turnover at CBER, spark fears of knowledge loss and delayed approvals within this critical innovative sector, triggering notable declines in related biotech stocks amid investor apprehension.