$STOK

Stoke Therapeutics (STOK) completed a meeting with the FDA to align on the planned U.S. NDA for zorevunersen, an investigational treatment for Dravet syndrome. The Phase 3 EMPEROR study will assess changes in cognition and behavior using four Vineland-3 subdomains. Data submissions are expected in the first half of 2027, with a Phase 3 readout anticipated in Q3 2027. The company plans to complete the NDA submission in the second half of 2027.

Stoke Therapeutics (STOK) aligned with the FDA on its U.S. NDA plan for zorevunersen, including a multicomponent Vineland-3 analysis. The company aims to complete the NDA in H2 2027, following a Phase 3 readout expected in Q3 2027. The FDA meeting was a mid-cycle regulatory de-risking step for Stoke's lead program.

Jonathan Allan, General Counsel & Corp Sec at Stoke Therapeutics (STOK), sold 627 shares on 2026-10-02, per an SEC filing. This follows a year of insider selling, with no insider buys. The stock trades at $26.33, with a market cap of $1.65B, and is deemed significantly overvalued by GF Value.

Stoke Therapeutics, Inc. (STOK) filed an SEC Form 8-K — Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers. Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers (b) On September 22, 2026, Edward M. Kaye, M.D. notified the Board of Directors (the “Board”) of Stoke Therapeutics, Inc. (t

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 (STOK) announced key milestones, including a phase III readout for Dravet syndrome within 12 months and progress in ADOA trials. Zorevunersen showed sustained 75% seizure reduction and functional gains, with long-term efficacy supported by OLE data. The EMPEROR study is well-powered, and the company's commercial strategy leverages robust clinical evidence.

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 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) 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.