UniQure warned investors that the FDA’s feedback on its Huntington’s disease gene therapy indicates a longer, more difficult approval path than expected. Company minutes show agency staff raised concerns about the completeness of the current dataset, prompting UniQure to plan urgent follow‑up meetings and consider additional trials or extended follow‑up. The FDA’s stance wiped out significant market value for UniQure and underscores growing regulatory caution on in‑vivo and CNS gene therapies. Companies developing similar one‑time genetic interventions now face heightened uncertainty over evidentiary expectations and potential demands for larger, longer studies.