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Stoke Therapeutics (STOK)

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Earnings summaries and quarterly performance for Stoke Therapeutics.

Recent press releases and 8-K filings for STOK.

Stoke Therapeutics Provides Update on Zorevunersen Phase 3 Study and Pipeline
STOK
Product Launch
New Projects/Investments
Guidance Update
  • Stoke Therapeutics expects to complete enrollment for its zorevunersen Phase 3 EMPEROR study in Q2 2026, with data readout anticipated in mid-2027 to support a rolling NDA submission in H1 2027.
  • The company has a strategic collaboration with Biogen for zorevunersen, which includes an upfront payment of $165 million and potential milestone payments of $385 million.
  • Stoke's financial position is strong, with a cash runway extending into 2028, supported by approximately $391.7 million as of December 31, 2025, plus proceeds from the Biogen collaboration.
  • The pipeline is expanding with the initiation of a Phase 1 study for STK-002 for Autosomal Dominant Optic Atrophy (ADOA) and the expectation to identify a clinical candidate for SYNGAP1 in 2026.
2 days ago
Stoke Therapeutics Provides Update on Zorevunersen Phase 3 Progress and Financial Outlook
STOK
Guidance Update
New Projects/Investments
  • Stoke Therapeutics expects to complete enrollment for its Phase 3 study of zorevunersen for Dravet syndrome in Q2 2026, with potential NDA approval in 2027 or early 2028 via a rolling submission.
  • The company reported a strong financial position with approximately $400 million as of the end of 2025, providing a cash runway through 2028.
  • Stoke sold approximately $100 million in stock during Q4 through an ATM to two tier-one long investors, further strengthening its financial position.
  • The pipeline includes STK-002 for Autosomal Dominant Optic Atrophy (ADOA), with the first patient expected to be dosed in H1 2026, and a clinical candidate for SYNGAP1 expected in Q1 2026.
  • Stoke is collaborating with Biogen, which licensed commercial rights to zorevunersen in February 2025 and funds 30% of R&D.
2 days ago
Stoke Therapeutics Provides Update on Zorevunersen Development and 2026 Milestones
STOK
Guidance Update
New Projects/Investments
  • Stoke Therapeutics' lead medicine, zorevunersen for Dravet syndrome, is in a Phase 3 study, with enrollment expected to be completed by Q2 2026.
  • The company anticipates potential NDA approval for zorevunersen as early as Q4 2027, utilizing Breakthrough Designation for a rolling submission starting in early 2027.
  • The pipeline includes STK-002 for Autosomal Dominant Optic Atrophy (ADOA), with the first patient dose expected in the first half of 2026, and a clinical candidate for SYNGAP1 to be identified in Q1 2026.
  • Stoke Therapeutics is "very well financed" and strengthened its financial position by selling approximately $100 million in Q4 via an ATM, with no current need to raise additional funds.
2 days ago
Stoke Therapeutics Provides Update on Zorevunersen Phase III Trial and Pipeline at J.P. Morgan Healthcare Conference
STOK
New Projects/Investments
Guidance Update
  • The zorevunersen Phase III study for Dravet syndrome, initiated mid-2025, has 60 patients recruited and randomized, with another 60 in an 8-week screening period. Enrollment completion is expected in Q2 2026, with potential NDA approval as early as Q4 2027 due to Breakthrough Designation and rolling submission.
  • Stoke Therapeutics reported approximately $400 million in cash as of the end of 2025, providing a cash runway through 2028. The company also sold approximately $100 million in stock in Q4 2025 through an ATM to strengthen its financial position.
  • The company expects to dose the first patient in its STK-002 program for Autosomal Dominant Optic Atrophy (ADOA) in the first half of 2026 and identify a clinical candidate for SYNGAP1 in Q1 2026. Clinical data for zorevunersen shows 80-85% seizure reduction and neurocognition benefits, with the company aiming for a label reflecting disease modification.
2 days ago
Stoke Therapeutics Updates Timelines for EMPEROR Study and Provides Financial Guidance
STOK
Guidance Update
New Projects/Investments
  • Stoke Therapeutics expects to complete enrollment of 150 patients in the Phase 3 EMPEROR study in Q2 2026, with a Phase 3 data readout anticipated in mid-2027.
  • The company plans to initiate a rolling New Drug Application (NDA) submission for zorevunersen for Dravet syndrome in the first half of 2027.
  • As of December 31, 2025, Stoke Therapeutics had approximately $391.7 million in cash, cash equivalents, and marketable securities, which, combined with eligible proceeds from the Biogen collaboration, is anticipated to fund operations into 2028.
3 days ago
Stoke Therapeutics Updates Zorevunersen Phase 3 Study Timelines and Financial Guidance
STOK
Guidance Update
Financial Guidance
New Projects/Investments
  • Stoke Therapeutics anticipates completing enrollment of 150 patients in the Phase 3 EMPEROR study for zorevunersen in Q2 2026.
  • A Phase 3 data readout is expected in mid-2027, with plans to initiate a rolling New Drug Application (NDA) submission in the first half of 2027.
  • Discussions with the FDA are ongoing regarding potential expedited regulatory pathways for zorevunersen, which has Breakthrough Therapy Designation.
  • The company reported approximately $391.7 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which are projected to fund operations into 2028.
4 days ago
Stoke Therapeutics and Biogen Present Zorevunersen Data at 2025 AES Annual Meeting
STOK
New Projects/Investments
  • Stoke Therapeutics and Biogen announced data presentations on December 5, 2025, at the 2025 American Epilepsy Society (AES) Annual Meeting, supporting zorevunersen as a potential disease-modifying medicine for Dravet syndrome.
  • Long-term Phase 1/2a and open label extension (OLE) studies demonstrated durable seizure reductions, including increases in seizure-free days, and improvements in cognition, behavior, and quality of life in patients treated with zorevunersen.
  • A propensity score weighted analysis showed statistically significant reductions in major motor seizure frequency at six months and improvements in cognition and behavior at 18 months compared to natural history, consistent with Phase 3 study endpoints.
  • Analysis of electroencephalogram (EEG) data highlighted dose-dependent effects in decreasing abnormal brain activity and an association with meaningful seizure reduction, supporting a disease-modifying mechanism of action.
  • Zorevunersen was generally well tolerated across the Phase 1/2a and OLE studies, with the most common study drug related adverse event being CSF protein elevations.
Dec 5, 2025, 2:05 PM
Stoke Therapeutics Discusses Zorevunersen Progress, CEO Transition, and Financial Outlook
STOK
CEO Change
Guidance Update
New Projects/Investments
  • 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
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
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

Quarterly earnings call transcripts for Stoke Therapeutics.