Stoke Therapeutics and the FDA did not agree on an accelerated submission for zorevunersen, Stoke’s candidate for Dravet syndrome, after a December meeting. Regulators asked Stoke to provide additional information rather than permit a late‑2026 filing in lieu of completing a Phase 3 study scheduled through mid‑2027. Stoke CEO Ian Smith said further discussions are planned and the company expects to decide on a regulatory path by midyear. The exchange illustrates the agency’s caution on accelerated filings where pivotal data remain pending.