Register Login

STOKE THERAPEUTICS, INC. (STOK)

(10% Negative) STOKE THERAPEUTICS, INC. (STOK) Announces Delay in treatment Trials for Dravet syndrome Due to Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

Full text
Register to leave comments
  • News bot June 30, 2026, 12:03 p.m.

    📋 STOKE THERAPEUTICS, INC. (STOK) - Clinical Trial Update

    Filing Date: 2026-06-30

    Accepted: 2026-06-30 08:02:16

    Event Type: Clinical Trial Update

    Event Details:

    STOKE THERAPEUTICS, INC. (STOK) Announces Clinical Trial Update STOKE THERAPEUTICS, INC. (STOK) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: treatment, change
    • Diseases/Conditions: Dravet syndrome, major motor seizure frequency is measured
    • Clinical Stage: Phase 3
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Patient Enrollment, Regulatory Process
    • Collaboration: New Drug Application
      • planned for inclusion in the U.S. NDA submission to the FDA. About Dravet Syndrome Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. Even when treated with the best available anti-seizure medicines (ASMs), up to 57% of patients with Dravet syndrome do not achieve ≥50% reduction in seizure frequency. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP; up to 20% of children and adolescents with Dravet syndrome die before adulthood due to SUDEP, prolonged seizures, seizure-related accidents or infections 1. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan 2. There are no approved disease-modifying therapies for people living with Dravet syndrome. About Zorevunersen Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing functional NaV1.1 protein production in brain cells from the unaffected (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function in the SCN1A gene, and China’s Center for Drug Evaluation has granted zorevunersen Breakthrough Therapy Designation. Stoke has a strategic collaboration with Biogen (Nasdaq: BIIB) to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. Zorevunersen is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. About the Phase 3 EMPEROR Study The Phase 3 EMPEROR Study (NCT0687
      • anticipated in the third quarter of 2027

    🔬 Clinical Development Pipeline (STOKE THERAPEUTICS, INC.):

    Product Type Development Stage Therapeutic Area Source
    zorevunersen Other Phase PHASE3 Dravet Syndrome ClinicalTrials.gov
    Sham Comparator Other Phase PHASE3 Dravet Syndrome ClinicalTrials.gov
    STK-001 - Multiple Ascending Doses Other Phase PHASE1 Dravet Syndrome ClinicalTrials.gov
    STK-001 - Single Ascending Doses Other Phase PHASE1 Dravet Syndrome ClinicalTrials.gov
    zorevunersen (STK-001) Other Phase PHASE2 Dravet Syndrome ClinicalTrials.gov

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: STOKE THERAPEUTICS, INC.
    • Ticker Symbol: STOK

Search

News categories