Stoke Therapeutics reported that the FDA declined to agree to an accelerated filing for zorevunersen, its experimental treatment for Dravet syndrome, after a December meeting. Regulators did not rule out an earlier submission but requested additional information; Stoke CEO Ian Smith said the company expects to decide on a regulatory path by midyear and will continue discussions with the agency. The exchange highlights the FDA’s current caution around accelerated pathways for high‑impact neurological drugs and underscores the need for dossiers that convincingly bridge remaining evidence gaps. A delayed filing shifts timing for potential approvals and commercialization planning.