Stoke Therapeutics and the FDA failed to reach agreement on an accelerated filing pathway for zorevunersen, the company’s treatment for Dravet syndrome, after a December meeting. Regulators did not reject the request outright but asked Stoke for additional information and signaled further discussions; the company expects to decide on a regulatory path by mid‑2026. The update comes from an interview with CEO Ian Smith reported by STAT. For context: zorevunersen is being developed to treat severe, early‑onset epilepsy tied to SCN1A mutations.