Kyverna Therapeutics to Highlight Interim Phase 2 Data from KYV-101 KYSA-6 Study in Myasthenia Gravis at AANEM 2025
Kyverna Therapeutics (Nasdaq: KYTX) announced it will present interim Phase 2 data from its KYSA-6 study of KYV-101 in myasthenia gravis (MG) at the AANEM Annual Meeting in October 2025. The presentation will include topline efficacy and safety data for 6 patients with up to 9 months of follow-up.
The company has successfully transformed the Phase 2 open-label study into a registrational Phase 2/3 trial following FDA alignment. Kyverna plans to initiate the Phase 3 portion by year-end 2025. The study evaluates KYV-101, a CD19 CAR T-cell therapy designed to achieve durable drug-free, disease-free remission with a single dose in patients with generalized myasthenia gravis (gMG).
Kyverna Therapeutics (Nasdaq: KYTX) ha annunciato che presenterà i dati interims della fase 2 dal suo studio KYSA-6 su KYV-101 nella miastenia gravis (MG) all'Assemblea annuale AANEM nell'ottobre 2025. La presentazione includerà dati di efficacia e sicurezza principali per 6 pazienti con un follow-up fino a 9 mesi.
L'azienda ha trasformato con successo lo studio di fase 2 in aperto in un progetto di trial registrazionale di fase 2/3 in seguito all'allineamento con la FDA. Kyverna intende avviare la parte di fase 3 entro la fine del 2025. Lo studio valuta KYV-101, una terapia con cellule T CAR CD19 progettata per ottenere una remissione durevole, senza farmaci, e libera dalla malattia con una sola dose in pazienti con miastenia gravis generalizzata (gMG).
Kyverna Therapeutics (Nasdaq: KYTX) anunció que presentará datos intermedios de la fase 2 de su estudio KYSA-6 de KYV-101 en la miastenia gravis (MG) en la Reunión Anual de AANEM en octubre de 2025. La presentación incluirá datos de eficacia y seguridad principales para 6 pacientes con hasta 9 meses de seguimiento.
La compañía ha transformado con éxito el estudio de fase 2 abierto en un ensayo registrativo de fase 2/3 tras la alineación con la FDA. Kyverna planea iniciar la porción de fase 3 antes de fin de 2025. El estudio evalúa KYV-101, una terapia de células CAR T CD19 diseñada para lograr una remisión duradera libre de fármacos y libre de la enfermedad con una única dosis en pacientes con miastenia gravis generalizada (gMG).
Kyverna Therapeutics (나스닥: KYTX)가 KYV-101를 이용한 중증 근무력증(MG) 연구 KYSA-6의 중간 2상 데이터를 2025년 10월 AANEM 연례회의에서 발표할 예정이라고 발표했다. 발표에는 최대 9개월의 추적 관찰이 포함된 6명의 환자에 대한 핵심 효능 및 안전성 데이터가 포함된다.
회사는 FDA의 합의에 따라 2상 오픈-label 연구를 등록 가능 2/3상 시험으로 성공적으로 전환했다. Kyverna는 2025년 말까지 3상 부분을 시작할 계획이다. 이 연구는 CD19 CAR T 세포 치료제 KYV-101을 평가하며, 단일 투여로 일반화된 중증 근무력증(gMG) 환자에서 약물 없이 질병이 유지되는 remission을 달성하는 것을 목표로 한다.
Kyverna Therapeutics (Nasdaq: KYTX) a annoncé qu'elle présentera des données intermédiaires de la phase 2 de son étude KYSA-6 de KYV-101 dans la myasthénie grave (MG) lors de la réunion annuelle AANEM en octobre 2025. La présentation inclura des données d'efficacité et de sécurité principales pour 6 patients avec un suivi allant jusqu'à 9 mois.
L'entreprise a réussi à transformer l'étude de phase 2 en ouvert en un essai registrational de phase 2/3 suite à l'alignement avec la FDA. Kyverna prévoit d'entreprendre la partie phase 3 d'ici la fin de 2025. L'étude évalue KYV-101, une thérapie par cellules CAR T CD19 conçue pour obtenir une rémission durable, sans médicament, et sans maladie, après une seule dose chez les patients atteints de myasthénie grave généralisée (gMG).
Kyverna Therapeutics (Nasdaq: KYTX) gab bekannt, dass sie im Oktober 2025 auf der AANEM-Jahrestagung Zwischendaten der Phase-2-Studie KYSA-6 von KYV-101 bei der Myasthenia gravis (MG) vorstellen wird. Die Präsentation wird erste Wirksamkeits- und Sicherheitsdaten von 6 Patienten mit bis zu 9 Monaten Nachbeobachtung beinhalten.
Das Unternehmen hat die Phase-2-Open-Label-Studie erfolgreich in eine registrational Phase 2/3-Studie nach FDA-Ausrichtung überführt. Kyverna plant, den Phase-3-Teil bis Ende 2025 zu starten. Die Studie bewertet KYV-101, eine CD19 CAR-T-Zelltherapie, die darauf abzielt, eine dauerhafte, medikamentenfreie und krankheitsfreie Remission mit einer einzelnen Dosis bei Patienten mit generalisierter Myasthenia gravis (gMG) zu erreichen.
Kyverna Therapeutics (نازداك: KYTX) أعلنت أنها ستعرض بيانات المرحلة 2 الوسيطة من دراستها KYSA-6 لـ KYV-101 في الوهن العضلي الوبيل (MG) في الاجتماع السنوي AANEM في أكتوبر 2025. ستشمل العرض بيانات الفعالية والسلامة الأساسية لـ 6 مرضى مع متابعة تصل إلى 9 أشهر.
نجحت الشركة في تحويل دراسة المرحلة 2 المفتوحة إلى تجربة مرحلة 2/3 تسجيلية بعد توافق FDA. تخطط Kyverna لبدء الجزء من المرحلة 3 بحلول نهاية عام 2025. تقيّم الدراسة KYV-101، علاج خلايا CAR T من CD19 مصمم لتحقيق تقليل دائم في الاعتماد على الأدوية وشفاء من المرض مع جرعة واحدة في المرضى المصابين بالوهن العضلي الوبيل العام (gMG).
Kyverna Therapeutics (纳斯达克：KYTX)宣布将于2025年10月在AANEM年会上公布其KYSA-6研究中KYV-101在重度重症肌无力（MG）中的中期2期数据。该演示将包括6名患者的初步有效性和安全性数据，随访时间最长可达9个月。
公司已将2期开放标签研究成功转化为注册性2/3期试验，符合FDA对齐。 Kyverna计划在2025年年末前启动第3阶段。该研究评估KYV-101，一种CD19 CAR-T细胞治疗，旨在通过单次给药实现持久药物无依赖、无疾病的缓解，适用于广泛性重症肌无力（gMG）患者。
- Study upgraded to registrational Phase 2/3 trial following FDA alignment
- Phase 3 portion of KYSA-6 trial on track to begin by end of 2025
- Additional pipeline catalyst expected with stiff person syndrome data in H1 2026
- None.
Insights
Kyverna's upcoming MG trial data presentation represents a key milestone for their CAR-T program, with Phase 3 initiation approaching.
Kyverna Therapeutics is set to present interim Phase 2 data for KYV-101 in myasthenia gravis (MG) at the upcoming AANEM conference. The data will cover six patients with up to nine months of follow-up, providing crucial insights into both efficacy and safety profiles. This presentation is particularly significant as it will inform the company's registrational Phase 3 portion of the KYSA-6 trial, which is on track to begin by year-end 2025.
What's scientifically notable here is KYV-101's investigational approach to treating autoimmune conditions with CAR T-cell therapy - a modality that has traditionally been used primarily in oncology. The company's stated goal of achieving "durable drug-free, disease-free remission with a single dose" represents an ambitious therapeutic paradigm for autoimmune disease management. If successful, this would contrast sharply with current MG treatments that typically require ongoing medication.
The amendment of the trial from a Phase 2 study to a registrational Phase 2/3 study following FDA alignment suggests regulatory confidence in the development program. This streamlined clinical pathway could accelerate time-to-market if the data proves supportive. The company is also leveraging this CAR-T platform beyond MG, with a pipeline that includes a program for stiff person syndrome with pivotal data expected in H1 2026.
While this is an interim data set from a small patient cohort (n=6), it will provide the first meaningful clinical evidence for assessing KYV-101's potential in addressing the underlying autoimmune mechanisms of MG, rather than just symptom management. The presentation by Dr. Srikanth Muppidi will be closely watched for signs of clinical benefit balanced against the safety profile, which is particularly important given the known risks associated with CAR T-cell therapies.
Oral presentation to include topline efficacy and safety data for 6 patients with up to 9 months of follow up
Enrollment for registrational Phase 3 portion of KYSA-6 trial in MG on track to initiate by year-end 2025
EMERYVILLE, Calif., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that interim data from the Phase 2 portion of the KYSA-6 study of KYV-101 in myasthenia gravis (MG), will be presented during an oral presentation at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting, taking place October 29 – November 1, 2025, in San Francisco, CA.
“We look forward to sharing interim data from our Phase 2 trial in myasthenia gravis, where we aim to continue to build a body of scientific evidence supporting KYV-101’s potential to deliver durable drug-free, disease-free remission with a single dose,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “This data readout marks an important milestone for the Company as we advance our neuroimmunology CAR T franchise – actively preparing for the initiation of the registrational Phase 3 portion of our myasthenia gravis trial this year, as well as the topline pivotal data readout for stiff person syndrome in the first half of next year.”
Following alignment with the FDA, the KYSA-6 Phase 2 open-label, single-arm, multicenter study of KYV-101 in generalized myasthenia gravis (gMG) was amended into a registrational Phase 2/3 study. The interim Phase 2 results that will be presented at AANEM will include top-line efficacy and safety data for six patients with up to nine months of follow-up. At the time the abstract was submitted, five patients had been dosed; the oral presentation will report on these patients as well as early data for a sixth patient who was dosed recently.
Presentation Details
Title: Update on the Phase 2 Part of KYSA-6, an Open-Label, Single-Arm, Multicenter Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor T-Cell Therapy in Generalized Myasthenia Gravis
Presenter: Srikanth Muppidi, M.D.
Date and Time: Wednesday, October 29, 2025, 11:00 AM PT
About KYV-101
KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, KYV-101 has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases.
About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit https://kyvernatx.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the topics to be discussed at the AANEM annual meeting; KYV-101’s potential to deliver durable drug-free, disease-free remission with a single dose; the expected timing for enrolling the first patient in the Phase 3 portion of the registrational MG trial; the trial design for the registrational MG trial; Kyverna's engagement with regulators; the expected timing for reporting interim data for the Phase 2 portion of the MG trial; and Kyverna's clinical trials, investigator initiated trials and named-patient access data. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient activities and preclinical studies may not necessarily be predictive of future results; intellectual property rights; and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts:
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com
FAQ
What interim data will Kyverna Therapeutics (KYTX) present at AANEM 2025?
When will Kyverna Therapeutics begin the Phase 3 portion of the KYSA-6 trial?
What is KYV-101 designed to achieve in myasthenia gravis patients?
Who will present the KYSA-6 trial data at AANEM 2025?
What type of study is the KYSA-6 trial?
