Stoke Therapeutics (STOK) Company Report

Ian Smith has transitioned from interim to full-time CEO of Stoke Therapeutics.
The company's lead program, zorevunersen for Dravet syndrome, is in Phase 3 following positive Phase 1/2 and OLE data demonstrating up to 80-85% median reduction in seizures and neurodevelopmental benefits, with a favorable safety profile.
Stoke Therapeutics holds Breakthrough Therapy Designation for zorevunersen and will meet with the FDA in December to discuss a potential NDA filing based on existing Phase 1/2 and OLE data.
Enrollment for the Phase 3 study is progressing well, with over 25 patients dosed and 30-40 in pre-screen; full recruitment is targeted for H2 2026, leading to a data readout in H2 2027.
The company maintains a strong financial position with approximately $400 million in cash (pro forma Q3), providing a cash runway through mid-2028.

Nov 11, 2025, 2:00 PM

Transcript

Stoke Therapeutics Reports Q3 2025 Financials and Zorevunersen Development Progress

STOK

Earnings

Guidance Update

New Projects/Investments

Stoke Therapeutics reported $328.6 million in cash, cash equivalents, and marketable securities as of September 30, 2025, with a projected cash runway extending to mid-2028.
The company generated $10.6 million in revenue for Q3 2025 and $183 million in year-to-date revenue.
The global pivotal Phase 3 EMPEROR study for zorevunersen is underway, with the first patient dosed in August 2025 and over 20 patients randomized as of October 2025. Enrollment is anticipated to be completed in the second half of 2026.
Zorevunersen received FDA Breakthrough Therapy Designation in December 2024, and preparations are ongoing for an FDA Multi-Disciplinary Meeting before year-end to discuss potential expedited regulatory pathways.

Nov 4, 2025, 9:30 PM

Presentation

Stoke Therapeutics Reports Q3 2025 Financials and Zorevunersen Phase 3 Progress

STOK

Earnings

Guidance Update

New Projects/Investments

Stoke Therapeutics reported $10.6 million in total revenue for Q3 2025, up from $4.9 million in Q3 2024, and a net loss of $38.3 million or $0.65 per share. The company ended the quarter with $328.6 million in cash, cash equivalents, and marketable securities, with a cash runway extending to mid-2028.
The Phase 3 Emperor study for zorevunersen in Dravet syndrome is actively recruiting, with over 20 patients randomized across 30 sites. Enrollment is anticipated to conclude in the second half of 2026, with data expected in the second half of 2027, leading to a potential NDA filing in late 2027, early 2028.
Stoke is engaging with the FDA to explore expedited regulatory pathways for zorevunersen, which holds Breakthrough Therapy Designation. The drug has demonstrated a generally well-tolerated safety profile in clinical studies, with observed CSF protein elevations not associated with clinical manifestations.

Nov 4, 2025, 9:30 PM

Transcript

Stoke Therapeutics Reports Q3 2025 Financial Results and Provides Business Updates

STOK

Earnings

Guidance Update

New Projects/Investments

Stoke Therapeutics reported $10.6 million in revenue and a net loss of $38.3 million ($0.65 per share) for Q3 2025, while year-to-date 2025 revenue was $183.0 million with a net income of $51.0 million ($0.85 per diluted share).
As of September 30, 2025, the company had $328.6 million in cash, cash equivalents, and marketable securities, anticipated to fund operations to mid-2028.
The global Phase 3 EMPEROR study for zorevunersen has more than 20 patients randomized and is on track to complete enrollment in the second half of 2026.
The company plans to meet with the FDA before year-end 2025 to review four years of safety and efficacy data for zorevunersen and discuss potential expedited regulatory pathways under its Breakthrough Therapy Designation.

Nov 4, 2025, 9:05 PM

8-K

Stoke Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Updates

STOK

Earnings

CEO Change

New Projects/Investments

Stoke Therapeutics reported $328.6 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is anticipated to fund operations to mid-2028.
For the third quarter ended September 30, 2025, the company recognized revenue of $10.6 million and a net loss of $38.3 million, or $0.65 per share.
Year-to-date September 30, 2025, revenue was $183.0 million, resulting in a net income of $51.0 million, or $0.85 per diluted share.
The global Phase 3 EMPEROR study for zorevunersen is actively recruiting, with more than 20 patients randomized as of the end of October 2025, and enrollment is on track to complete in the second half of 2026.
Ian F. Smith was appointed Chief Executive Officer in October 2025.

Nov 4, 2025, 9:01 PM

Press Release

Stoke Therapeutics and Biogen Present Positive Zorevunersen Data for Dravet Syndrome

STOK

New Projects/Investments

Biogen and Stoke Therapeutics presented promising long-term follow-up data for zorevunersen in Dravet syndrome, demonstrating sustained cognitive and behavioral improvements over two years and 95% of patients showing overall clinical status improvements at three years.
The data also highlighted substantial reductions in seizure frequency and a manageable safety profile, with related adverse events occurring in 30% of Phase 1/2a participants and 53% of open-label extension participants.
The most effective regimen, a 70mg loading dose followed by 45mg maintenance doses, is currently being evaluated in the Phase 3 EMPEROR study.
Dravet syndrome affects up to 38,000 people across the US, Europe, and Japan, indicating a significant market need for effective treatments.

Oct 9, 2025, 11:26 PM

Morningstar

Stoke Therapeutics and Biogen Present Positive Zorevunersen Data for Dravet Syndrome

STOK

New Projects/Investments

Stoke Therapeutics and Biogen announced new longer-term follow-up analyses from open-label extension studies of zorevunersen for Dravet syndrome, supporting its potential as a disease-modifying medicine.
The data showed continuing improvements in cognition and behavior at 2 years and improvements in overall clinical status at 3 years in 95% of patients treated with zorevunersen, which contrasts with minimal change in natural history.
Zorevunersen also demonstrated substantial and durable reductions in major motor seizure frequency and improvements in cognition and behavior through three years. The Phase 3 EMPEROR study is evaluating a dosing regimen of 70mg loading doses followed by 45mg maintenance doses.
The drug was generally well tolerated, with CSF protein elevations being the most common study drug related adverse event. Zorevunersen has received Orphan Drug Designation, Rare Pediatric Disease Designation, and Breakthrough Therapy Designation for Dravet syndrome.

Oct 9, 2025, 8:30 PM

Press Release

Stoke Therapeutics and Biogen Present Positive Long-Term Zorevunersen Data for Dravet Syndrome

STOK

New Projects/Investments

Biogen and Stoke Therapeutics announced longer-term follow-up analyses for zorevunersen at the 54th Child Neurology Society (CNS) Annual Meeting, supporting its potential as a disease-modifying medicine for Dravet syndrome.
The analyses showed continuing improvements in cognition and behavior at two years and improvements in overall clinical status in 95% of patients at three years, as reported by clinicians and caregivers.
Zorevunersen demonstrated substantial and durable reductions in major motor seizure frequency and improvements in cognition and behavior through three years in open-label extension studies.
The drug was generally well tolerated, with the most common study drug related adverse event being CSF protein elevations, observed in 14% of patients in Phase 1/2a and 44% in OLE studies.
Zorevunersen has received Orphan Drug Designation from the FDA and EMA, and Rare Pediatric Disease and Breakthrough Therapy Designation from the FDA for Dravet syndrome.

Oct 9, 2025, 8:30 PM

Press Release

Earnings Transcripts

Quarterly earnings call transcripts for Stoke Therapeutics.

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