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

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8-K
Rhea-AI Filing Summary

Kyverna Therapeutics (KYTX)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.

Slides for the call are furnished as Exhibit 99.1. The information was furnished under Item 7.01 and is not deemed “filed” under the Exchange Act.

Kyverna Therapeutics (KYTX)) ha annunciato dati provvisori positivi dalla porzione di fase 2 del suo KYSA-6 studio di fase 2/3 di KYV-101 nella miastenia gravis generalizzata. L'azienda terrà una conferenza telefonica alle ore 8:00, ora della Eastern Time, il 29 ottobre 2025 per rivedere i risultati.

Le diapositive per la chiamata sono fornite come Exhibit 99.1. Le informazioni sono state fornite ai sensi dell'Item 7.01 e non sono considerate “depositato” ai sensi del Exchange Act.

Kyverna Therapeutics (KYTX)) anunció datos interinos positivos de la porción de fase 2 de su ensayo KYSA-6 fase 2/3 de KYV-101 en la miastenia gravis generalizada. La empresa organizará una conferencia telefónica a las 8:00 a. m. hora del Este, el 29 de octubre de 2025 para revisar los resultados.

Las diapositivas para la llamada se adjuntan como Exhibit 99.1. La información se proporcionó de acuerdo con el ítem 7.01 y no se considera “presentada” bajo la Exchange Act.

Kyverna Therapeutics (KYTX))는 일반화된 중증 근무력증에서 KYV-101의 KYSA-6 2상/3상 시험의 2상 부분의 긍정적 중간 데이터를 발표했습니다. 회사는 결과를 검토하기 위해 2025년 10월 29일 동부 표준시 8:00에 컨퍼런스 콜을 개최할 예정입니다.

콜용 슬라이드는 Exhibit 99.1로 제공됩니다. 이 정보는 Item 7.01에 따라 제공되었으며 Exchange Act에 따라 “파일링”으로 간주되지 않습니다.

Kyverna Therapeutics (KYTX)) a annoncé des données intermédiaires positives provenant de la partie Phase 2 de son essai KYSA-6 Phase 2/3 de KYV-101 chez la myasthénie gravis généralisée. L'entreprise organisera une conférence téléphonique à 8h00, heure de l'Est, le 29 octobre 2025 pour examiner les résultats.

Les diapositives de l'appel sont fournies en tant que Exhibit 99.1. L'information a été fournie conformément à l'article 7.01 et n'est pas considérée comme « déposée » en vertu du Exchange Act.

Kyverna Therapeutics (KYTX)) kündigte positive Zwischenmeldungen aus dem Phase-2-Teil der KYSA-6 Phase-2/3-Studie von KYV-101 bei generalisierter Myasthenia gravis an. Das Unternehmen wird eine Telefonkonferenz um 8:00 Uhr Eastern Time am 29. Oktober 2025 abhalten, um die Ergebnisse zu besprechen.

Die Folien für den Anruf werden als Exhibit 99.1 vorgelegt. Die Informationen wurden gemäß Item 7.01 bereitgestellt und gelten gemäß dem Exchange Act nicht als „eingegangen“.

Kyverna Therapeutics (KYTX)) أعلنت عن بيانات وسيطة إيجابية من جزء المرحلة 2 من تجربتها KYSA-6 المرحلة 2/3 لـ KYV-101 في مرض الوهن العضلي الوبيل العام. ستعقد الشركة مكالمة مؤتمرات هاتفية في الساعة 8:00 صباحاً بتوقيت الساحل الشرقي في 29 أكتوبر 2025 لاستعراض النتائج.

شرائح المكالمة مُدرجة كـ Exhibit 99.1. تم إدراج المعلومات وفق البند 7.01 ولا تعتبر “مودعة” وفقاً لقانون تبادل الأوراق المالية Exchange Act.

Positive
  • None.
Negative
  • None.

Kyverna Therapeutics (KYTX)) ha annunciato dati provvisori positivi dalla porzione di fase 2 del suo KYSA-6 studio di fase 2/3 di KYV-101 nella miastenia gravis generalizzata. L'azienda terrà una conferenza telefonica alle ore 8:00, ora della Eastern Time, il 29 ottobre 2025 per rivedere i risultati.

Le diapositive per la chiamata sono fornite come Exhibit 99.1. Le informazioni sono state fornite ai sensi dell'Item 7.01 e non sono considerate “depositato” ai sensi del Exchange Act.

Kyverna Therapeutics (KYTX)) anunció datos interinos positivos de la porción de fase 2 de su ensayo KYSA-6 fase 2/3 de KYV-101 en la miastenia gravis generalizada. La empresa organizará una conferencia telefónica a las 8:00 a. m. hora del Este, el 29 de octubre de 2025 para revisar los resultados.

Las diapositivas para la llamada se adjuntan como Exhibit 99.1. La información se proporcionó de acuerdo con el ítem 7.01 y no se considera “presentada” bajo la Exchange Act.

Kyverna Therapeutics (KYTX))는 일반화된 중증 근무력증에서 KYV-101의 KYSA-6 2상/3상 시험의 2상 부분의 긍정적 중간 데이터를 발표했습니다. 회사는 결과를 검토하기 위해 2025년 10월 29일 동부 표준시 8:00에 컨퍼런스 콜을 개최할 예정입니다.

콜용 슬라이드는 Exhibit 99.1로 제공됩니다. 이 정보는 Item 7.01에 따라 제공되었으며 Exchange Act에 따라 “파일링”으로 간주되지 않습니다.

Kyverna Therapeutics (KYTX)) a annoncé des données intermédiaires positives provenant de la partie Phase 2 de son essai KYSA-6 Phase 2/3 de KYV-101 chez la myasthénie gravis généralisée. L'entreprise organisera une conférence téléphonique à 8h00, heure de l'Est, le 29 octobre 2025 pour examiner les résultats.

Les diapositives de l'appel sont fournies en tant que Exhibit 99.1. L'information a été fournie conformément à l'article 7.01 et n'est pas considérée comme « déposée » en vertu du Exchange Act.

Kyverna Therapeutics (KYTX)) kündigte positive Zwischenmeldungen aus dem Phase-2-Teil der KYSA-6 Phase-2/3-Studie von KYV-101 bei generalisierter Myasthenia gravis an. Das Unternehmen wird eine Telefonkonferenz um 8:00 Uhr Eastern Time am 29. Oktober 2025 abhalten, um die Ergebnisse zu besprechen.

Die Folien für den Anruf werden als Exhibit 99.1 vorgelegt. Die Informationen wurden gemäß Item 7.01 bereitgestellt und gelten gemäß dem Exchange Act nicht als „eingegangen“.

Kyverna Therapeutics (KYTX)) أعلنت عن بيانات وسيطة إيجابية من جزء المرحلة 2 من تجربتها KYSA-6 المرحلة 2/3 لـ KYV-101 في مرض الوهن العضلي الوبيل العام. ستعقد الشركة مكالمة مؤتمرات هاتفية في الساعة 8:00 صباحاً بتوقيت الساحل الشرقي في 29 أكتوبر 2025 لاستعراض النتائج.

شرائح المكالمة مُدرجة كـ Exhibit 99.1. تم إدراج المعلومات وفق البند 7.01 ولا تعتبر “مودعة” وفقاً لقانون تبادل الأوراق المالية Exchange Act.

Kyverna Therapeutics (KYTX)) 宣布其 KYSA-6 第2/3期试验中 KYV-101 在广泛性重症肌无力中的中期数据呈阳性。公司将于 2025年10月29日,东部时间上午8:00 举行电话会议以回顾结果。

该电话的幻灯片以 Exhibit 99.1 形式提供。该信息是根据第 7.01 条提供,不被视为在美国证券交易法下“已提交/备案”。

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 (the “Conference Call”). A copy of the slides to be used in connection with the Conference Call 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    Kyverna Therapeutics, Inc. Presentation - Interim Data for KYSA-6 Phase 2 Clinical Trial of KYV-101 in Generalized Myasthenia Gravis, Conference Call, 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

FAQ

What did Kyverna Therapeutics (KYTX) announce?

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

When is KYTX discussing the KYV-101 results?

Kyverna will host a conference call at 8:00 a.m. Eastern Time on October 29, 2025 to review the interim results.

Where can I find the presentation materials for the KYTX call?

Slides are furnished as Exhibit 99.1 titled “Interim Data for KYSA-6 Phase 2 Clinical Trial of KYV-101 in Generalized Myasthenia Gravis.”

Is the KYTX information considered filed with the SEC?

No. The information in Item 7.01 (including Exhibit 99.1) is furnished and not deemed “filed” under the Exchange Act.

What program is KYV-101 being studied in?

KYV-101 is being studied in the KYSA-6 Phase 2/3 trial for generalized myasthenia gravis.

What is the form of this disclosure by KYTX?

This is an 8-K current report providing a business update under Item 7.01 (Regulation FD Disclosure).
Kyverna Therapeutics

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Biotechnology
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