The FDA has moved away from public advisory‑committee engagements in a high‑profile dispute with uniQure over its Huntington’s disease gene therapy candidate, according to reporting by STAT. Agency officials privately criticized the company’s data and recommended additional, controlled trials rather than relying on earlier external‑control evidence. The development has triggered intense investor swings in uniQure shares as the market digests the likelihood of more onerous regulatory requirements.
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