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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) 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.

Kyverna Therapeutics (KYTX) ha annunciato dati intermedi positivi dalla fase 2 della porzione KYSA-6 di un trial fase 2/3 che valuta KYV-101 nella miastenia gravis generalizzata. L'azienda ha programmato una conference call alle 8:00 ora orientale il 29 ottobre 2025 per discutere i risultati. L'annuncio è stato fornito ai sensi del regolamento FD per garantire una divulgazione ampia e simultanea.

I dettagli sono stati forniti come Exhibit 99.1 e, in linea con la pratica regolamentare FD, non sono considerati "depositati" ai fini della Sezione 18 dello Exchange Act. Questo segnala un aggiornamento del programma clinico più che un cambiamento nei dati finanziari o nelle previsioni. Il filing indica come exhibits il comunicato stampa e la pagina di copertina Inline XBRL.

Kyverna Therapeutics (KYTX) anunció datos interinos positivos de la porción de fase 2 de su ensayo fase 2/3 KYSA-6 que evalúa KYV-101 en la miastenia gravis generalizada. La empresa programó una llamada de conferencia a las 8:00 a.m., hora del Este, el 29 de octubre de 2025 para revisar los resultados. El anuncio se proporcionó bajo Regulation FD para garantizar una divulgación amplia y simultánea.

Los detalles se presentaron como Exhibit 99.1 y, de acuerdo con la práctica de Regulation FD, no se consideran "presentados" a efectos de la Sección 18 de la Exchange Act. Esto señala una actualización del programa clínico más que un cambio en los estados financieros o en las proyecciones. El filing lista el comunicado de prensa y la página de portada Inline XBRL como exhibiciones.

Kyverna Therapeutics (KYTX)가 KYSA-6 2/3 단계의 중간 데이터가 긍정적이라고 발표했습니다. 이 회사의 일반화된 중증 근무력증에 대한 KYV-101 평가를 포함하는 KYSA-6 2상/3상 시험의 2상 부분에서 나온 결과입니다. 회사는 2025년 10월 29일 동부 표준시 8:00에 결과를 검토하기 위한 컨퍼런스 콜을 예정했습니다. 이 발표는 광범위하고 동시적 공개를 보장하기 위한 Regulation FD에 따라 제공되었습니다.

자세한 내용은 Exhibit 99.1로 제공되었으며 Regulation FD 규정에 따라 Exchange Act 제18조의 목적상 “제출”로 간주되지 않습니다. 이는 재무 제표나 가이던스의 변경이 아닌 임상 프로그램 업데이트를 알리는 신호입니다. 이 filing은 보도자료와 Inline XBRL 표지 페이지를 전시로 목록화하고 있습니다.

Kyverna Therapeutics (KYTX) a annoncé des données intermédiaires positives concernant la partie phase 2 de son essai KYSA-6 phase 2/3 évaluant KYV-101 dans la myasthénie grave généralisée. L'entreprise a prévu une conférence téléphonique à 8h00, heure de l'Est, le 29 octobre 2025 pour examiner les résultats. L'annonce a été fournie en vertu du Regulation FD afin d'assurer une diffusion large et simultanée.

Les détails ont été fournis en tant qu'Exhibit 99.1 et, conformément à la pratique Regulation FD, ne sont pas considérés comme des « déposés » aux fins de la Section 18 du Exchange Act. Cela signale une mise à jour du programme clinique plutôt qu'un changement des états financiers ou des prévisions. Le dépôt répertorie le communiqué de presse et la page de couverture Inline XBRL comme pièces jointes.

Kyverna Therapeutics (KYTX) meldete positive Zwischenresultate aus dem Phase-2-Teil der KYSA-6-Phase-2/3-Studie, in der KYV-101 bei generalisierter Myasthenia gravis untersucht wird. Das Unternehmen hat einen Conference Call um 8:00 Uhr Eastern Time am 29. Oktober 2025 angekündigt, um die Ergebnisse zu besprechen. Die Bekanntgabe erfolgte gemäß Regulation FD, um eine breite, gleichzeitige Offenlegung sicherzustellen.

Die Details wurden als Exhibit 99.1 übermittelt und entsprechen gemäß der Regulation-FD-Praxis nicht dem Begriff „eingereicht“ im Sinne von Section 18 des Exchange Act. Dies kennzeichnet ein Update des klinischen Programms und keinen Änderungsbedarf bei den Finanzberichten oder der Guidance. Die Einreichung führt die Pressemitteilung und die Inline XBRL-Titelseite als Exhibits auf.

أعلنت Kyverna Therapeutics (KYTX) عن بيانات وسيطة إيجابية من الجزء الخاص بالمرحلة 2 من تجربة KYSA-6 المرحلة 2/3 التي تقيم KYV-101 في الوهن العضلي الشديد المنتشر. حددت الشركة مكالمة مؤتمرات في الساعة 8:00 صباحاً بتوقيت الساحل الشرقي في 29 أكتوبر 2025 لمراجعة النتائج. تم توفير الإعلان بموجب Regulation FD لضمان نشر واسع ومتزامن.

تم تقديم التفاصيل كمعروض 99.1 وبما يتسق مع ممارسة Regulation FD، لا تعتبر «مودعة» لأغراض القسم 18 من قانون التبادل. وهذا يشير إلى تحديث في البرنامج السريري بدلاً من تغيير في البيانات المالية أو التوجيه. يسرد الملف الصحفي وصفحة الغلاف Inline XBRL كمعروضات.

Positive
  • None.
Negative
  • None.

Kyverna Therapeutics (KYTX) ha annunciato dati intermedi positivi dalla fase 2 della porzione KYSA-6 di un trial fase 2/3 che valuta KYV-101 nella miastenia gravis generalizzata. L'azienda ha programmato una conference call alle 8:00 ora orientale il 29 ottobre 2025 per discutere i risultati. L'annuncio è stato fornito ai sensi del regolamento FD per garantire una divulgazione ampia e simultanea.

I dettagli sono stati forniti come Exhibit 99.1 e, in linea con la pratica regolamentare FD, non sono considerati "depositati" ai fini della Sezione 18 dello Exchange Act. Questo segnala un aggiornamento del programma clinico più che un cambiamento nei dati finanziari o nelle previsioni. Il filing indica come exhibits il comunicato stampa e la pagina di copertina Inline XBRL.

Kyverna Therapeutics (KYTX) anunció datos interinos positivos de la porción de fase 2 de su ensayo fase 2/3 KYSA-6 que evalúa KYV-101 en la miastenia gravis generalizada. La empresa programó una llamada de conferencia a las 8:00 a.m., hora del Este, el 29 de octubre de 2025 para revisar los resultados. El anuncio se proporcionó bajo Regulation FD para garantizar una divulgación amplia y simultánea.

Los detalles se presentaron como Exhibit 99.1 y, de acuerdo con la práctica de Regulation FD, no se consideran "presentados" a efectos de la Sección 18 de la Exchange Act. Esto señala una actualización del programa clínico más que un cambio en los estados financieros o en las proyecciones. El filing lista el comunicado de prensa y la página de portada Inline XBRL como exhibiciones.

Kyverna Therapeutics (KYTX)가 KYSA-6 2/3 단계의 중간 데이터가 긍정적이라고 발표했습니다. 이 회사의 일반화된 중증 근무력증에 대한 KYV-101 평가를 포함하는 KYSA-6 2상/3상 시험의 2상 부분에서 나온 결과입니다. 회사는 2025년 10월 29일 동부 표준시 8:00에 결과를 검토하기 위한 컨퍼런스 콜을 예정했습니다. 이 발표는 광범위하고 동시적 공개를 보장하기 위한 Regulation FD에 따라 제공되었습니다.

자세한 내용은 Exhibit 99.1로 제공되었으며 Regulation FD 규정에 따라 Exchange Act 제18조의 목적상 “제출”로 간주되지 않습니다. 이는 재무 제표나 가이던스의 변경이 아닌 임상 프로그램 업데이트를 알리는 신호입니다. 이 filing은 보도자료와 Inline XBRL 표지 페이지를 전시로 목록화하고 있습니다.

Kyverna Therapeutics (KYTX) a annoncé des données intermédiaires positives concernant la partie phase 2 de son essai KYSA-6 phase 2/3 évaluant KYV-101 dans la myasthénie grave généralisée. L'entreprise a prévu une conférence téléphonique à 8h00, heure de l'Est, le 29 octobre 2025 pour examiner les résultats. L'annonce a été fournie en vertu du Regulation FD afin d'assurer une diffusion large et simultanée.

Les détails ont été fournis en tant qu'Exhibit 99.1 et, conformément à la pratique Regulation FD, ne sont pas considérés comme des « déposés » aux fins de la Section 18 du Exchange Act. Cela signale une mise à jour du programme clinique plutôt qu'un changement des états financiers ou des prévisions. Le dépôt répertorie le communiqué de presse et la page de couverture Inline XBRL comme pièces jointes.

Kyverna Therapeutics (KYTX) meldete positive Zwischenresultate aus dem Phase-2-Teil der KYSA-6-Phase-2/3-Studie, in der KYV-101 bei generalisierter Myasthenia gravis untersucht wird. Das Unternehmen hat einen Conference Call um 8:00 Uhr Eastern Time am 29. Oktober 2025 angekündigt, um die Ergebnisse zu besprechen. Die Bekanntgabe erfolgte gemäß Regulation FD, um eine breite, gleichzeitige Offenlegung sicherzustellen.

Die Details wurden als Exhibit 99.1 übermittelt und entsprechen gemäß der Regulation-FD-Praxis nicht dem Begriff „eingereicht“ im Sinne von Section 18 des Exchange Act. Dies kennzeichnet ein Update des klinischen Programms und keinen Änderungsbedarf bei den Finanzberichten oder der Guidance. Die Einreichung führt die Pressemitteilung und die Inline XBRL-Titelseite als Exhibits auf.

أعلنت Kyverna Therapeutics (KYTX) عن بيانات وسيطة إيجابية من الجزء الخاص بالمرحلة 2 من تجربة KYSA-6 المرحلة 2/3 التي تقيم KYV-101 في الوهن العضلي الشديد المنتشر. حددت الشركة مكالمة مؤتمرات في الساعة 8:00 صباحاً بتوقيت الساحل الشرقي في 29 أكتوبر 2025 لمراجعة النتائج. تم توفير الإعلان بموجب Regulation FD لضمان نشر واسع ومتزامن.

تم تقديم التفاصيل كمعروض 99.1 وبما يتسق مع ممارسة Regulation FD، لا تعتبر «مودعة» لأغراض القسم 18 من قانون التبادل. وهذا يشير إلى تحديث في البرنامج السريري بدلاً من تغيير في البيانات المالية أو التوجيه. يسرد الملف الصحفي وصفحة الغلاف Inline XBRL كمعروضات.

Kyverna Therapeutics (KYTX) 公布了其 KYSA-6 2/3 试验中 KYV-101 在泛发性重症肌无力中的阶段2中期数据为积极结果。该公司计划于美东时间 2025 年 10 月 29 日上午 8:00 举行电话会议,讨论结果。该公告依照 Regulation FD 提供,以确保广泛、同步披露。

详细信息以 Exhibit 99.1 形式提供,并且与 Regulation FD 的做法一致,不被视为就《证券交易法》第18条“提交”的目的而“提交”。这表明这是一次临床项目进展更新,而非对财务报表或指引的变更。该 filing 将新闻稿与 Inline XBRL 封面页列为展品。

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

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).
Kyverna Therapeutics

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