Two regulatory actions this week signaled growing scrutiny on gene‑therapy development. UniQure said FDA feedback indicates its Huntington’s gene therapy AMT‑130 will likely face a longer, more complex path to approval than expected; the company is seeking urgent follow‑up discussions with the agency. Separately, the FDA placed a clinical hold on Denali Therapeutics’ planned Phase 1 rare‑disease study, citing immune‑reaction concerns from preclinical models. Both companies reported the developments in investor statements and regulatory notices. The twin setbacks highlight heightened agency caution on safety signals and the potential need for expanded datasets or additional studies before filing for approval, complicating timelines and capital planning for gene‑therapy developers.