[8-K] Stoke Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

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.

Positive

• First patient dosed in the global Phase 3 EMPEROR study of zorevunersen for Dravet syndrome
• Joint announcement with Biogen International GmbH, indicating partner collaboration on the program
• Press release furnished as Exhibit 99.1, creating an official public disclosure of the event

Negative

• None.

Insights

Clinical Development Specialist

TL;DR: First patient dosing in a global Phase 3 trial is a clear clinical progression for zorevunersen and confirms active enrollment.

The announcement that the first patient has been dosed in the global Phase 3 EMPEROR study confirms transition of zorevunersen into a late-stage, global clinical evaluation for Dravet syndrome. This filing furnishes the partner joint press release with Biogen as Exhibit 99.1, establishing public record of trial initiation activity. From a development standpoint, first-dose announcements typically indicate protocol activation and initial site readiness, which are observable program milestones for investors and stakeholders.

Biotechnology Equity Analyst

TL;DR: The joint release with Biogen about Phase 3 dosing is materially positive as evidence of program advancement and partner alignment.

Stoke Therapeutics publicly disclosed that the first patient was dosed in the global Phase 3 EMPEROR trial for zorevunersen and furnished the press release as Exhibit 99.1. The joint nature of the announcement with Biogen International GmbH reinforces the ongoing collaboration. The Form 8-K clarifies the press release is furnished (not filed), which is standard practice for corporate communications while preserving certain legal protections.

false 0001623526 0001623526 2025-08-11 2025-08-11

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2025

Stoke Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-38938		47-1144582
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

45 Wiggins Ave
Bedford, Massachusetts		01730
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (781) 430-8200

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		STOK		Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD.

On August 11, 2025, Stoke Therapeutics, Inc. (the “Company”) and Biogen International GmbH issued a joint press release (the “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 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 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Press Release dated August 11, 2025
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: August 11, 2025				By:		/s/ Thomas E. Leggett
						Thomas E. Leggett Chief Financial Officer

FAQ

What did Stoke Therapeutics (STOK) report in this 8-K?

The company and Biogen announced that the first patient has been dosed in the global Phase 3 EMPEROR study of zorevunersen for Dravet syndrome; the announcement is furnished as Exhibit 99.1.

Which clinical study was started for zorevunersen?

The global Phase 3 EMPEROR study for the treatment of Dravet syndrome, with the first patient dosed according to the press release.

Who partnered with Stoke on the announcement?

The press release was jointly issued with Biogen International GmbH.

Is the press release considered formally filed with the SEC?

No. The filing states the press release and related information are furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act.

Who signed the Form 8-K for Stoke Therapeutics?

The report is signed on behalf of the registrant by Thomas E. Leggett, Chief Financial Officer.