Highest-materiality recent filing
Stoke Therapeutics files prospectus supplement for up to $200M ATM offering
Filed prospectus supplement on Aug 3, 2026 to sell up to $200M of common stock.
Stoke Therapeutics Q2 net loss $61.6M; Phase 3 EMPEROR enrollment complete at 162 patients
Net loss of $61.6M ($0.93 per share) vs $23.5M loss in Q2 2025; revenue fell to $9.3M from $13.8M.
Completed enrollment of 162 patients in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome.
Net loss $50.0M ($0.79/share) vs prior-year net income $112.9M; revenue $6.2M down from $158.6M due to 2025 Biogen license revenue.
Stoke Therapeutics dismisses KPMG, appoints Ernst & Young as auditor
On March 23, 2026, Audit Committee dismissed KPMG as independent registered public accounting firm.
Stoke Therapeutics enters $85.5M lease for 98,500 sq ft Waltham HQ/lab through 2038
New lease with NWALP PHOP Property Owner LLC for 98,500 sq ft at 245 Fifth Avenue, Waltham, MA.
Stoke Therapeutics accelerates EMPEROR enrollment, expects Phase 3 data in mid-2027, cash $391.7M
Enrollment of 150 patients in Phase 3 EMPEROR study expected to complete in Q2 2026, accelerated from prior timeline.
Propensity score weighted analysis shows statistically significant reductions in major motor seizure frequency at 6 months (70mg loading dose) vs natural history.
Stoke Q3 net loss $38.3M ($0.65/sh); Phase 3 EMPEROR >20 randomized
Net loss $38.3M ($0.65/sh) vs $26.4M ($0.47) in Q3 2024; revenue $10.6M vs $4.9M.
Stoke Q2 net loss $23.5M; Phase 3 EMPEROR dosed, 3-year OLE data show durability
Net loss $23.5M ($0.40/sh) for Q2 2025 vs $25.7M loss in Q2 2024; H1 net income $89.4M from Biogen collaboration.
First patient dosed in Phase 3 EMPEROR study of zorevunersen for Dravet syndrome by Stoke and Biogen
First patient dosed in global Phase 3 EMPEROR study of zorevunersen for Dravet syndrome.
Analysis of patients on EMPEROR-like regimen (2x70mg loading + 2x45mg maintenance) showed cognition/behavior improvements at Week 68.
Stoke Therapeutics initiates Phase 3 EMPEROR study of zorevunersen; first US sites in May 2025
Initiated Phase 3 EMPEROR study of zorevunersen; first U.S. sites activated in May 2025.
Stoke Therapeutics Q1 2025 net income $112.9M; advances zorevunersen Phase 3 with Biogen
Net income $112.9M ($1.90 diluted EPS) in Q1 2025 vs net loss $26.4M ($0.57 per share) in Q1 2024.
Stoke Therapeutics CEO Kaye steps down; Ian Smith named interim; FY 2024 net loss $89M
CEO Edward Kaye steps down March 19; Ian F. Smith appointed Interim CEO; Arthur Tzianabos named Interim Executive Chair.
Stoke and Biogen enter $165M upfront collaboration for zorevunersen (Dravet syndrome)
Stoke receives $165M upfront; eligible for up to $385M in milestones and low-double-digit to high-teen royalties.
Stoke announces global regulatory alignment for Phase 3 study of zorevunersen in Dravet syndrome
Aligned with FDA, EMA, and PMDA for Phase 3 EMPEROR; study to start mid-2025, data by end of 2027.
Stoke Therapeutics receives FDA Breakthrough Therapy Designation for zorevunersen in Dravet syndrome
FDA granted Breakthrough Therapy Designation for zorevunersen to treat Dravet syndrome with a confirmed SCN1A mutation.
Cash, equivalents, and marketable securities $269.2M as of Sep 30, 2024.
Stoke Therapeutics Q2 net loss $25.7M; FDA lifts partial clinical hold on zorevunersen
FDA removed Partial Clinical Hold on zorevunersen for Dravet syndrome; planning Phase 3 registrational study.
Stoke Therapeutics Q1 net loss $26.4M; STK-001 data supports disease modification
Net loss $26.4M ($0.57/share) vs $22.5M ($0.53) YoY; cash $178.6M at March 31, plus $120.3M net from April follow-on offering.
Stoke Therapeutics names Thomas Leggett CFO; Stephen Tulipano resigns
Thomas Leggett appointed CFO effective May 7, 2024; previously CFO at Affinia Therapeutics and Black Diamond Therapeutics.
Stoke Therapeutics prices $125M public offering of common stock and pre-funded warrants
Priced 5,555,557 shares at $13.50/share and pre-funded warrants for 3,703,730 shares at $13.4999.
Stoke Therapeutics reports 2023 net loss $104.7M; cash $201.4M to fund to end 2025
Cash, equivalents & marketable securities $201.4M as of Dec 31, 2023; expected to fund operations through end of 2025.
Stoke reports STK-001 data: 85% median seizure reduction at 3 months; FDA allows 70mg dosing
Phase 1/2a: 70mg (2-3 doses) showed median 85% reduction in convulsive seizure frequency at 3 months (n=10) and 74% at 6 months (n=9) after last dose.
Stoke presents STK-001 data at AES 2023: seizure reductions and cognition gains in Dravet syndrome
Higher STK-001 brain exposure linked to greater seizure reductions in 72 patients (R=-0.23, P<0.001).
Stoke Therapeutics Q3 2023 net loss $24.5M; cash $214.7M funds into 2025
Net loss of $24.5M ($0.55 per share) vs $26.1M ($0.66) in Q3 2022.
Stoke Therapeutics Q2 2023 net loss $30.7M; cash $231.4M to fund operations to end of 2025
Net loss $30.7M ($0.69 per share) vs $24.7M ($0.63) in Q2 2022; R&D expenses $20.6M.
STK-001 70mg achieves 80% median convulsive seizure reduction at 3 months in Dravet syndrome
70mg multiple-dose cohort (n=6): median convulsive seizure reduction 80% at 3 months, 89% at 6 months after last dose.
Stoke Therapeutics Q1 2023 net loss $0.53/sh; cash $254.2M; mid-2023 STK-001 data expected
Net loss per share $0.53, revenue $5.2M from collaboration (up from $3.0M YoY).
FDA allows Stoke to administer higher 70mg single dose of STK-001 in Dravet syndrome study
FDA permits 70mg single dose cohort in Phase 1/2a MONARCH study; dosing expected in coming weeks.
Stoke Therapeutics reports FY2022 net loss $101.1M; STK-001 shows 55% median seizure reduction
Net loss for FY2022 was $101.1M ($2.60/share) vs $85.8M ($2.34/share) in 2021; revenue of $12.4M from license agreement.
Multiple-dose STK-001 45mg data expected mid-2023; 70mg data expected second half 2023.
55% median reduction in convulsive seizure frequency from baseline in 6 patients treated with three doses of 45mg STK-001.
STK-001 up to 45mg well-tolerated; 55% median reduction in convulsive seizures with three doses of 45mg (n=6).
On March 16, 2025, Dr. Edward Kaye, M.D., 75, the Company’s Chief Executive Officer (“CEO”) and a director, informed the Company’s Board of Directors (the “Board”) of his intention to step down from his position as the Company’s CEO, effective March 19, 2025 (the “Transition Date”).
Also in connection with Dr. Kaye’s transition, effective as of the Transition Date, the Board appointed Arthur Tzianabos, 61, currently Chair of the Board, as Interim Executive Chair of the Board.
Effective as of the Transition Date, the Board appointed Ian F. Smith, 59, a director on the Board, to succeed Dr. Kaye as Interim Chief Executive Officer (“Interim CEO”).
On June 18, 2024, Stoke Therapeutics, Inc. (the “Company”) and Huw Nash, Ph.D., the Company’s Chief Operating Officer and Chief Business Officer, announced that they have mutually agreed that Dr. Nash would step down from his position as Chief Operating Officer, effective immediately.
appointed Thomas Leggett as the Chief Financial Officer of the Company
Resignation of Chief Financial Officer Effective as of the Appointment Date, the Company’s current Chief Financial Off
elected Ian F. Smith, to serve on the Board as a Class II director, effective immediately.
Max materiality 0.90 · Median 0.65 · Most common event other_material