Kaye Edward M. MD sold $403K of STOK

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.

Stoke Therapeutics (STOK) and Biogen (BIIB) presented 4-year data from Phase 1/2a studies of zorevunersen, an investigational treatment for Dravet syndrome, at the 16th European Epilepsy Congress. The data showed sustained improvements in cognition, behavior, and seizure reduction, with a generally well-tolerated safety profile. The Phase 3 EMPEROR study is ongoing, with results expected in Q3 2027.

Stoke Therapeutics (NASDAQ:STOK) said its Phase III EMPEROR trial for zorevunersen in Dravet syndrome met enrollment targets with zero dropouts. The FDA granted breakthrough therapy designation. The study will assess seizures and Vineland-3 cognitive and behavioral endpoints. Stoke plans a rolling NDA start in Q1 2027, completing in Q3 2027.

Stoke Therapeutics (STOK) reported Phase III EMPEROR enrollment completion of 162 patients and said a Phase III readout is expected in Q3 2027. Rolling NDA submissions are planned for Q1 2027, with a potential early 2028 launch of zorevunersen. Q2 revenue was $9.3M and net loss $61.6M. Pro forma cash was about $420M.