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Stoke Therapeutics
Stoke Therapeutics (STOK) investor relations material
Stoke Therapeutics TD Cowen 46th Annual Health Care Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.TD Cowen 46th Annual Health Care Conference summary3 Mar, 2026
Key clinical development updates
EMPEROR phase III study for Dravet syndrome is enrolling well, with completion of enrollment expected in Q2 and data anticipated by mid-2027.
The study includes 150-160 lumbar puncture sham control patients, with additional cohorts in Europe and Japan to support regulatory and reimbursement requirements.
Primary endpoint is seizure reduction at 26 weeks, with secondary endpoints including continuous seizure reduction at 52 weeks and multiple Vineland-3 domains assessing cognition and behavior.
Longitudinal open-label extension (OLE) data show robust seizure reduction and improvements in cognition and behavior over up to three years, with potential for five-year data at filing.
Central neuropsychologist raters ensure consistency in Vineland-3 assessments across sites.
Regulatory and labeling strategy
Breakthrough designation allows for frequent FDA interactions, focusing on demonstrating both seizure reduction and disease-modifying effects on cognition and behavior.
Labeling strategy leverages Section 14 (CLINICAL STUDIES) to include observed longitudinal data, aiming to differentiate the therapy as more than an anti-seizure medicine.
The anticipated label is for patients two years and older, aligning with the Breakthrough designation.
Hierarchical assessment of Vineland-3 domains in the US and composite scoring in Europe are used for secondary endpoints.
Market opportunity and pricing
Approximately 35,000-40,000 Dravet patients exist in core geographies, with 6,000 immediately addressable upon launch, primarily pediatric and young adult patients.
Improved genetic testing and ICD-10 coding are expected to increase identification of eligible patients over time.
Pricing is expected to be benchmarked against other genetically targeted, disease-modifying therapies like SPINRAZA and Vertex CF medicines, rather than traditional anti-seizure drugs.
Access strategy is designed to ensure broad patient availability, with pricing reflecting the value of disease modification.
How does OLE data shape the final label?
Justify STK-001 pricing vs. anti-seizure meds.
When to expect ADOA efficacy data?
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Next Stoke Therapeutics earnings date
Q4 202519 Mar, 2026
Stoke Therapeutics
Next Stoke Therapeutics earnings date
Q4 202519 Mar, 2026
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Frequently asked questions
Stoke Therapeutics Inc. is a biotechnology firm focused on innovative treatments for severe genetic diseases by enhancing protein expression through RNA-based medicines. The company leverages its proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) technology to develop antisense oligonucleotides (ASOs) aimed at selectively restoring protein levels. This approach is particularly geared towards addressing diseases caused by haploinsufficiencies, where a loss of about 50% of normal protein levels leads to illness. The company is headquartered in Bedford, Massachusetts, and its shares are listed on the Nasdaq.
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