UniQure warned investors that the FDA’s recent feedback on its Huntington’s disease gene therapy will likely delay an anticipated approval filing and complicate its regulatory path. The company restated agency concerns it received earlier and said the current data package may not support an immediate submission; shares fell markedly on the update. UniQure described the FDA’s position as requiring additional evidence beyond what the company had expected based on prior discussions. Management plans to request an urgent follow-up meeting with regulators to clarify data expectations and determine the next steps, which could include enlarging key trials or extending follow-up. Stakeholders in the gene-therapy and neurodegeneration space should follow the dialogue closely: the FDA’s stance signals sustained scrutiny for in vivo CNS gene programs and may affect development plans, timelines and investor expectations across similar programs.