Stocks of gene‑therapy developers swung sharply after reports that Vinayak (Vinay) Prasad will step down as FDA CBER director, a change that followed high‑profile agency demands for additional trials in gene‑therapy applications. uniQure and peers rallied on the prospect of a leadership shift and a potentially more industry‑facing regulatory stance. Market coverage noted extreme volatility: uniQure shares plunged and rebounded across days as the agency and company traded public statements over AMT‑130 data and the FDA’s recommendation for a sham‑surgery controlled study. The developments underscore how personnel changes at regulatory centers can re‑rate small, high‑volatility biotech names tied to contentious approval pathways. Regulatory context: the FDA’s insistence on randomized, sham‑controlled trials for some gene therapies has become a flashpoint between innovators and regulators, affecting investor confidence and program timelines.