STOK: Phase III data for Dravet syndrome and strong OLE results position the pipeline for major milestones

Stoke Therapeutics (STOK) appointed Bo Cumbo to its board, replacing Edward Kaye, who retired. Cumbo has extensive biopharma experience. Stoke is developing zorevunersen for Dravet syndrome, with potential FDA approval in 2028. It partners with Biogen (BIIB) for global commercialization, retaining U.S., Canada, and Mexico rights.

Stoke Therapeutics (STOK) presented at the Cantor Fitzgerald conference, highlighting progress in its Phase III EMPEROR trial for Dravet syndrome, which completed enrollment ahead of schedule with 162 patients. The company expects top-line data in Q3 2027 and plans a rolling NDA submission in H1 2027. Stoke reported $400M in pro forma cash as of June 30, 2024, providing a runway through early 2028. Open-label extension data show a 75% sustained seizure reduction over four years. The stock traded

Stoke Therapeutics and Biogen presented four-year data on zorevunersen, showing sustained seizure reductions and cognitive improvements in Dravet syndrome patients. The results, from Phase I/IIa studies and extensions, were shared at the 16th European Epilepsy Congress.

Stoke Therapeutics and Biogen reported long-term data for zorevunersen, an investigational Dravet syndrome therapy, showing sustained seizure reductions and cognitive improvements over four years. The Phase 3 EMPEROR trial has completed enrollment, with data expected in Q3 2027 ahead of a planned U.S. NDA submission.

Stoke Therapeutics and Biogen presented long-term data at the 16th European Epilepsy Congress, showing zorevunersen's potential in treating Dravet syndrome. The Phase 1/2a and OLE studies demonstrated durable seizure reductions, cognitive and behavioral improvements, and quality of life enhancements. The Phase 3 EMPEROR study data is expected in Q3 2027, aiming to complete the U.S. NDA submission. Zorevunersen was generally well tolerated, with some patients treated for over 5 years. Dravet synd

Stoke Therapeutics (STOK) and Biogen (BIIB) will present four-year data on zorevunersen, their experimental Dravet syndrome treatment, at the European Epilepsy Congress. The data shows sustained cognitive and behavioral improvements, reduced seizures, and a generally safe profile. 77% of patients remain in extension studies. Zorevunersen is in Phase 3 trials, with results expected in Q3 2027. The therapy has received FDA and EMA designations but is not yet approved.