uniQure’s gene‑therapy program for Huntington’s disease has been thrust into the spotlight after the FDA recommended a prospective, randomized, sham‑surgery‑controlled trial for AMT‑130, prompting sharp volatility in the company’s stock. The agency concluded earlier Phase I/II data compared to external controls were insufficient for approval. The public dispute intensified scrutiny of the FDA’s review standards for invasive gene therapies and coincided with the announced departure of Vinay Prasad from his FDA leadership role. Investors reacted to both the regulator’s demand for a new trial and leadership turnover, underscoring how regulatory strategy and agency personnel moves can materially affect biotech valuations and development timelines.