Every 8-K that Stoke Therapeutics (STOK) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow STOK and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full STOK filings page.
Stoke Therapeutics, Inc. filed a prospectus supplement relating to the offer and sale of up to $200,000,000 of common stock as “Placement Shares” under its existing Controlled Equity Sales Agreement with Cantor Fitzgerald & Co., structured as an at-the-market offering.
The prospectus supplement forms part of Stoke’s automatic shelf registration statement on Form S-3ASR (File No. 333-294402), originally filed March 18, 2026. A legal opinion from Fenwick & West LLP covering the Placement Shares is included as Exhibit 5.1, with a related consent and Inline XBRL cover data also provided.
Stoke Therapeutics reported Q2 2026 results reflecting continued investment ahead of potential commercialization. Revenue for the quarter was $9.3 million, primarily from collaboration and licensing agreements, and the company recorded a net loss of $61.6 million, or $0.93 per share, driven by higher research and development and sales, general and administrative expenses.
Cash, cash equivalents and marketable securities totaled $420.0 million, based on $354.3 million at June 30, 2026 plus $65.7 million of ATM proceeds, and these funds are expected to support operations through a potential U.S. commercialization of lead Dravet syndrome candidate zorevunersen in early 2028.
Enrollment is complete for 162 patients in the global Phase 3 EMPEROR study of zorevunersen, with a pre‑NDA FDA meeting planned for the second half of 2026, rolling NDA initiation in the first quarter of 2027 and a data readout anticipated in the third quarter of 2027. The Phase 1 OSPREY trial of STK‑002 for Autosomal Dominant Optic Atrophy is progressing through dose‑escalation cohorts, with initial safety and efficacy data expected in the first half of 2027.
Stoke Therapeutics reported completion of enrollment of 162 patients in its pivotal Phase 3 EMPEROR study of zorevunersen for Dravet syndrome across the U.S., U.K. and Japan. This late-stage trial will measure change in major motor seizure frequency at Week 28, with full analysis over 52 weeks.
About 50 patients have already reached 28 weeks of treatment, and an additional cohort of roughly 30 patients in Europe is still enrolling, with the last patient expected in August. Stoke plans to begin a rolling U.S. New Drug Application submission in the first quarter of 2027, aiming to complete it in the second half of 2027 after an anticipated Phase 3 data readout in the third quarter of 2027.
Stoke Therapeutics, Inc. reported the results of its 2026 Annual Meeting of Stockholders held on June 3, 2026. Stockholders elected directors G. Clare Kahn, Ph.D., Adrian Krainer, Ph.D., and Julie Anne Smith, each receiving tens of millions of shares voted in favor versus relatively small withheld votes, plus broker non-votes.
Stockholders also approved one proposal with 55,121,163 shares for, 2,036 against, and 51,714 abstaining, and another with 36,436,275 shares for, 13,565,293 against, 29,415 abstaining, and 5,143,930 broker non-votes. The filing confirms that these meeting outcomes are now formally recorded.
Stoke Therapeutics reported a first quarter 2026 net loss of $50.0 million, or $0.79 per share, as revenue normalized following a prior-year licensing milestone. Revenue was $6.2 million versus $158.6 million a year earlier, mainly because 2025 included $150.8 million of Biogen license revenue.
The company ended March 31, 2026 with $411.0 million in cash, cash equivalents and marketable securities, including $80.7 million raised via at-the-market share sales, which it expects to fund operations into 2028.
Stoke highlighted new 4-year open-label extension data for zorevunersen in Dravet syndrome showing durable seizure reductions and statistically significant cognitive and behavioral improvements, continued generally good tolerability, and progress in the global Phase 3 EMPEROR study expected to finish U.S./UK/Japan enrollment in June 2026 and support a planned rolling U.S. NDA submission starting in early 2027.
Stoke Therapeutics expanded its Board of Directors to ten members and appointed Clare Kahn, Ph.D. as a Class I director, effective April 3, 2026, with a term running until the 2026 annual meeting. She will serve on the Nominating and Corporate Governance Committee and chair the Research and Development Committee. Dr. Kahn is deemed an independent director and signed the company’s standard indemnity agreement.
Under the non-employee director compensation program, she will receive a $45,000 annual cash retainer and an initial stock option for 30,782 shares, with an approximate grant-date fair value of $724,000, vesting in twelve equal quarterly installments. The accompanying press release highlights Stoke’s lead RNA medicine candidate, zorevunersen, now in Phase 3 development for Dravet syndrome and partnered globally with Biogen outside North America.
Stoke Therapeutics changed its independent auditor, dismissing KPMG LLP and appointing Ernst & Young LLP (EY) as its new independent registered public accounting firm for the fiscal year ending December 31, 2026.
The company states that KPMG’s audit reports for 2024 and 2025 contained no adverse or qualified opinions, and there were no disagreements or reportable events under SEC rules through March 23, 2026. KPMG provided a letter to the SEC agreeing with these disclosures, which is included as an exhibit.
Stoke Therapeutics, Inc. reported that its Board of Directors approved a discretionary cash bonus of $697,125 for Chief Executive Officer Ian F. Smith. He did not participate in the company’s 2025 annual bonus program, and this bonus equals his full target annual bonus for that year.
The Board based the award on Stoke’s clinical and financial performance following Smith’s appointment as interim CEO in March 2025 and permanent CEO in October 2025. For the 2025 annual bonus program, the Board determined that corporate goal achievement for the company was 150% of target.
Stoke Therapeutics, Inc. entered into a new long-term lease for its corporate headquarters and laboratory space at 245 Fifth Avenue, Waltham, Massachusetts. The lease covers approximately 98,500 square feet and is scheduled to run through March 31, 2038, giving the company a stable base for its operations.
The agreement includes two options to extend the term by an additional five years each at then-prevailing market rates, which could keep the company in the facility well beyond 2038. Aggregate estimated base rent over the initial term is approximately $85.5 million, and the company will provide a $3 million security deposit via an irrevocable standby letter of credit that may be reduced over time under the lease terms.
Stoke Therapeutics filed an update describing a new press release about its Phase 3 EMPEROR study of zorevunersen for Dravet syndrome and its cash position. The company expects to report approximately $391.7 million in cash, cash equivalents and marketable securities as of December 31, 2025, and says that, together with eligible proceeds from its Biogen collaboration, this is anticipated to fund operations into 2028. The press release also updates timelines for completion of enrollment and Phase 3 data readout for EMPEROR and provides additional detail on the trial design. Management stresses that these financial figures are preliminary, unaudited estimates that may change once year-end closing procedures and the audit are completed, and highlights typical clinical, regulatory, collaboration and macroeconomic risks in its forward-looking statements.
Stoke Therapeutics, Inc. (STOK) filed an 8-K noting it issued a press release announcing financial results for the quarter ended September 30, 2025. The filing lists the press release as Exhibit 99.1 and identifies the company’s common stock as trading on the Nasdaq Global Select Market. This is a routine disclosure of quarterly results via press release.
Stoke Therapeutics entered into an executive employment agreement and a change-of-control and severance agreement with Ian F. Smith effective October 6, 2025. The employment package includes a $500,000 sign-on bonus (repayable if Mr. Smith leaves or is terminated for cause within 12 months), a $500,000 performance bonus contingent on meeting specified metrics, an option to purchase 570,000 shares vesting 25% at one year then monthly over four years, and 380,000 restricted stock units vesting in four equal annual installments. If terminated without cause or for good reason within the defined change-of-control window, Mr. Smith would receive 18 months of continued base salary, 150% of annual target bonus in a lump sum, up to 18 months of healthcare premium payments, and 100% accelerated vesting of outstanding equity awards. The agreements reference an S-1 filed June 7, 2019.
Stoke Therapeutics, Inc. filed an amended current report to disclose its decision on how often to hold non-binding advisory shareholder votes on executive compensation. Based on stockholder preferences expressed at the 2025 Annual Meeting and the Board’s prior recommendation, the company chose to hold Say-on-Pay votes every year.
The company plans to continue annual non-binding advisory Say-on-Pay votes until the next required Say-on-Frequency vote, which must occur no later than the 2031 Annual Meeting of Stockholders. No other changes were made to the previously reported 2025 Annual Meeting voting results.
Stoke Therapeutics reported financial results for the quarter ended June 30, 2025 and provided business updates, including new data from ongoing open label extension (OLE) studies of zorevunersen extending out to three years and the initiation of a Phase 1 clinical study of STK-002 in patients with Autosomal Dominant Optic Atrophy (ADOA).
The company furnished a press release and an investor presentation as Exhibits 99.1 and 99.2, with the presentation including certain key findings from an analysis of the OLE studies; the company states these materials are furnished, not filed, and are not incorporated by reference into other filings.
Stoke Therapeutics and Biogen issued a joint press release announcing that the first patient has been dosed in the global Phase 3 EMPEROR study of zorevunersen for the treatment of Dravet syndrome. The company furnished that press release as Exhibit 99.1 to this Form 8-K and also included the cover page interactive XBRL file.
The filing states the furnished information, including Exhibit 99.1, is not deemed "filed" for purposes of Section 18 of the Exchange Act and is not incorporated by reference into other filings unless expressly stated. The report is executed on behalf of Stoke by Chief Financial Officer Thomas E. Leggett.