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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 Updates on Dravet Syndrome and ADOA Programs, Financial Position
STOK
New Projects/Investments
Guidance Update
  • Stoke Therapeutics' Dravet syndrome program (STK-001) has demonstrated up to 80% seizure reduction and durable cognition and behavioral benefits over 3-4 years in Phase 1/2 data. Enrollment for the Phase 3 EMPEROR study is expected to complete in Q2 2026, with data anticipated in mid-2027.
  • The company recently initiated a clinical study for its Autosomal Dominant Optic Atrophy (ADOA) program, administering the first dose last week (prior to February 11, 2026), with data anticipated by end of 2026 or early H1 2027.
  • Stoke Therapeutics reported a cash position of approximately $400 million at the end of 2025, providing a cash runway that extends into 2028.
Feb 11, 2026, 7:30 PM
Stoke Therapeutics Provides Updates on Dravet Syndrome Phase 3 and Initiates ADOA Clinical Program
STOK
New Projects/Investments
Guidance Update
  • Stoke Therapeutics anticipates completing enrollment for its Dravet syndrome Phase 3 program in Q2 2026, with data expected in mid-2027.
  • The company recently dosed the first patient in its Phase 1/2 study for Autosomal Dominant Optic Atrophy (ADOA), with data readout projected for end of 2026 or early H1 2027.
  • Discussions with the FDA regarding accelerated approval for Dravet syndrome are ongoing, with the company prioritizing an optimal label from the Phase 3 study over an expedited timeline.
  • Stoke Therapeutics reported approximately $400 million in cash at the end of 2025, providing a cash runway into 2028, supported by Biogen funding 30% of Dravet R&D.
Feb 11, 2026, 7:30 PM
Stoke Therapeutics Provides Updates on Dravet Syndrome Phase 3 Program and ADOA Clinical Entry
STOK
New Projects/Investments
Guidance Update
  • Stoke Therapeutics' lead program for Dravet syndrome has demonstrated up to 80% reduction in seizures and cognition/behavioral benefits in initial Phase 1/2 data, with durability observed over 3 to 4 years.
  • The Phase 3 program for Dravet syndrome is projected to complete enrollment in Q2 2026, with data anticipated in mid-2027. The company is prioritizing an optimal label from the Phase 3 study over a potentially faster, but less comprehensive, accelerated approval pathway.
  • The company's second disease area, Autosomal Dominant Optic Atrophy (ADOA), entered the clinic last week, with efficacious dosing anticipated by Q4 2026 or H1 2027. The ADOA market is estimated at 16,000 patients in the top seven geographies.
  • The addressable patient population for Dravet syndrome in North America is approximately 8,000 today, with the company aiming for "Spinraza-like" pricing due to the medicine's disease-modifying potential.
  • Stoke Therapeutics reported approximately $400 million in cash at the end of 2025, with a cash runway extending into 2028. Biogen funds 30% of the Dravet R&D.
Feb 11, 2026, 7:30 PM
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.
Jan 14, 2026, 12:30 AM
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.
Jan 14, 2026, 12:30 AM
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.
Jan 14, 2026, 12:30 AM
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.
Jan 14, 2026, 12:30 AM
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.
Jan 12, 2026, 12:34 PM
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.
Jan 11, 2026, 7:00 PM
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

Quarterly earnings call transcripts for Stoke Therapeutics.