UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD. |
On June 30, 2026, Stoke Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the completion of enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen, a potential disease-modifying treatment for Dravet syndrome. The Company is furnishing a copy of the Press Release, which is attached hereto as Exhibit 99.1.
The information furnished with this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
As noted in the Press Release, enrollment of 162 patients into the EMPEROR study has now completed in the planned primary analysis population across the U.S., U.K., and Japan. A Phase 3 data readout from these patients is anticipated in the third quarter of 2027. Approximately 50 of these patients are through 28 weeks of treatment, the time point at which the primary endpoint of change in major motor seizure frequency is measured. The Company plans to initiate a rolling New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration in the first quarter of 2027 and expects completion of the NDA submission in the second half of 2027.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Press Release dated June 30, 2026 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| STOKE THERAPEUTICS, INC. | ||||||
| Date: June 30, 2026 | By: | /s/ Thomas E. Leggett | ||||
| Thomas E. Leggett Chief Financial Officer | ||||||