Current Report · Items 7.01, 8.01, 9.01 · 8-K

Stoke Therapeutics, Inc.

STOKNASDAQEQUITYCurrent

Regulation FD Disclosure · Other Events

Filed Jun 30, 2026Accepted Jun 30, 2026, 8:02 AM EDTCIK 1623526Accession 0001193125-26-289409

Company context

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal

Current securities

STOKNASDAQ · EQUITY · Current

Recent company filings

Disclosure sections

Items 7.01, 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure

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 8.01Item 8.01 - Other Events

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.

Filed exhibits (1)

EX-99.1 (by filename) d924679dex991.htm

EX-99.1 2 d924679dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Stoke Therapeutics Announces Completion of Enrollment of 162 Patients into the Phase 3 EMPEROR Study of Zorevunersen, an Investigational Medicine for the Treatment of Dravet Syndrome - Company plans to initiate a rolling U.S. NDA submission to the FDA in the first quarter of 2027 - - Phase 3 data readout anticipated in the third quarter of 2027 to complete the rolling U.S. NDA submission in the second half of 2027 - BEDFORD, Mass. - June 30, 2026 - Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced the completion of enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen. Stoke plans to initiate a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027. A Phase 3 data readout is anticipated in the third quarter of 2027 to complete the rolling U.S. NDA …

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