Kyverna (KYTX) announces positive Phase 2 KYV-101 data, Oct 29

Kyverna Therapeutics (KYTX) announced positive interim data from the Phase 2 portion of its KYSA-6 Phase 2/3 trial evaluating KYV-101 in generalized myasthenia gravis.

Rhea-AI Filing Summary

Kyverna Therapeutics (KYTX) announced positive interim data from the Phase 2 portion of its KYSA-6 Phase 2/3 trial evaluating KYV-101 in generalized myasthenia gravis. The company scheduled a conference call at 8:00 a.m. Eastern Time on October 29, 2025 to review the results. The announcement was provided under Regulation FD to ensure broad, simultaneous disclosure.

The details were furnished as Exhibit 99.1 and, consistent with Regulation FD practice, are not deemed “filed” for purposes of Section 18 of the Exchange Act. This signals a clinical program update rather than a change to financial statements or guidance. The filing lists the press release and the Inline XBRL cover page as exhibits.

8-K Event Classification

Item 7.01 — Regulation FD Disclosure

1 item

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

FAQ

What did Kyverna Therapeutics (KYTX) announce in this 8-K?

Kyverna reported positive interim data from the Phase 2 portion of the KYSA-6 Phase 2/3 trial of KYV-101 in generalized myasthenia gravis.

Which program and indication are referenced for KYTX?

The filing references KYV-101 in the KYSA-6 Phase 2/3 trial for generalized myasthenia gravis.

When is the Kyverna (KYTX) results call?

The company will host a conference call at 8:00 a.m. Eastern Time on October 29, 2025.

Where can I find the detailed results for KYTX?

Details are in the press release furnished as Exhibit 99.1.

Is this information considered 'filed' with the SEC?

No. The information under Item 7.01 is furnished, not filed, and is not subject to Section 18 liabilities.

Does this 8-K include financial statements?

No. It provides a Regulation FD update and lists exhibits including the press release (99.1) and the Inline XBRL cover page (104).

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Accepted by SEC EDGAR 10/29/2025 - 06:32 AM Learn about SEC filing dates

false 0001994702 0001994702 2025-10-29 2025-10-29

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): October 29, 2025

Kyverna Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-41947		83-1365441
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

5980 Horton St., Suite 550
Emeryville, California		94608
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (510) 925-2492

(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, par value $0.00001 per share		KYTX		The Nasdaq Stock Market LLC

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 Disclosure.

On October 29, 2025, Kyverna Therapeutics, Inc. (the “Company”) issued a press release announcing positive interim data from the Phase 2 portion from its KYSA-6 Phase 2/3 trial of KYV-101 in generalized myasthenia gravis. The Company will host a conference call at 8:00 a.m. Eastern Time on October 29, 2025 to review the results. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) 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 in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number		Description
99.1		Press Release issued by Kyverna Therapeutics, Inc., dated October 29, 2025.
104		Cover Page Interactive Data File (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.

						KYVERNA THERAPEUTICS, INC.
Date:  October 29, 2025				By:		/s/ Marc Grasso
						Marc Grasso Chief Financial Officer