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Stoke Therapeutics (STOK) investor relations material
Stoke Therapeutics Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary11 Nov, 2025
Leadership and strategic direction
CEO Ian Smith transitioned from interim to full-time CEO, bringing experience from Vertex and deep familiarity with genetic pediatric diseases.
Focus remains on advancing therapies for haploinsufficient diseases, with Dravet syndrome as the lead indication.
Collaboration with Biogen has been productive, supporting organizational growth and financing.
Clinical development and data highlights
Lead therapy targets Dravet syndrome by upregulating NaV1.1 protein, addressing the root genetic cause.
Phase I/II and OLE studies show up to 80%-85% median reduction in seizures, sustained over four years.
Significant improvements in cognition and behavior observed, measured by Vineland-3 scores and supported by physician presentations.
Safety profile is favorable, with over 800 doses administered and high patient retention in long-term studies.
CSF protein elevations observed post-lumbar puncture are random and not clinically significant.
Phase III trial design and progress
Phase III mirrors prior studies in patient criteria, with primary endpoint at week 28 (seizure reduction) and secondary endpoints at week 52 (durability and cognition/behavior).
Study is well-powered (90% confidence for 0.01 result), with over 25 patients dosed and 30-40 in screening.
Full enrollment (170 patients) expected by H2 2026, with data readout in H2 2027.
What is the path for early NDA filing?
How to expand Dravet patient reach beyond 6k?
ADOA: When to expect efficacy data?
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Next Stoke Therapeutics earnings date
Q4 202519 Mar, 2026
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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