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Kyverna Therapeutics (Nasdaq: KYTX) is set to present interim Phase 2 results from its KYSA-6 study, evaluating KYV-101 in the treatment of myasthenia gravis (MG), at the upcoming AANEM Annual Meeting in October 2025. The presentation will highlight topline efficacy and safety data derived from six patients, with a follow-up period extending to nine months.
The company has announced the successful evolution of the initial Phase 2 open-label study into a registrational Phase 2/3 trial, a move that followed alignment with the FDA. Kyverna intends to commence the Phase 3 component of the trial by the close of 2025. KYV-101, the subject of this study, is a CD19 CAR T-cell therapy engineered to induce sustained, drug-free, and disease-free remission after a single dose in patients diagnosed with generalized myasthenia gravis (gMG).
Positive
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
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.
09/15/2025 – 01:02 PM
Kyverna Therapeutics (Nasdaq: KYTX) is poised to unveil interim Phase 2 data from its KYSA-6 trial targeting myasthenia gravis (MG) with KYV-101. The oral presentation, scheduled at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting from October 29 to November 1, 2025, in San Francisco, CA, promises to shed light on the potential of CAR-T cell therapy in autoimmune disease management.
“We anticipate sharing interim data from our Phase 2 trial in myasthenia gravis, aiming to fortify the scientific basis supporting KYV-101’s capability to achieve durable drug-free and disease-free remission with a single dose,” stated Warner Biddle, CEO of Kyverna Therapeutics. “This data readout signifies a pivotal moment for our company as we propel our neuroimmunology CAR T franchise forward. We are actively preparing for the Phase 3 initiation of our myasthenia gravis trial this year, concurrently anticipating topline pivotal data for stiff person syndrome in the first half of next year, adding significant catalysts to our pipeline.”
The KYSA-6 trial has been upgraded from a Phase 2 open-label, single-arm, multicenter study to a registrational Phase 2/3 study, a direct consequence of alignment with the FDA. The AANEM presentation will feature topline efficacy and safety outcomes derived from six patients observed for up to nine months. While the abstract submission involved data from five patients, the upcoming oral presentation will also incorporate early findings from a sixth patient who was recently dosed. The study design incorporates rigorous safety monitoring protocols, considering the inherent risks associated with CAR-T cell therapies, particularly cytokine release syndrome and neurotoxicity. This approach underscores the necessity for meticulous clinical management and robust data analysis in this evolving therapeutic landscape.
The therapeutic premise of KYV-101 hinges on its capacity to selectively deplete B-cells – a key player in autoimmune pathology. By leveraging a fully human, autologous CD19 CAR T-cell equipped with CD28 co-stimulation, the design seeks to achieve deep B-cell depletion and a subsequent reset of the immune system, potentially resulting in long-lasting remission. This contrasts with conventional myasthenia gravis treatments which mainly focus on symptomatic alleviation and, frequently, necessitate sustained medication. The registrational Phase 2/3 design significantly accelerates the pathway for potential regulatory approval pending positive results.
The company’s strategic expansion into stiff person syndrome exemplifies their commitment to broadening the application of their CAR-T platform beyond isolated indications. This strategic diversification not only mitigates clinical development risks but also taps into significant commercial opportunities across a broader spectrum of autoimmune disorders. The forthcoming data readout for stiff person syndrome in H1 2026 is poised to further validate the versatility and potential of Kyverna’s CAR-T technology.
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 .
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.
What interim data will Kyverna Therapeutics (KYTX) present at AANEM 2025?
Kyverna will present topline efficacy and safety data from 6 patients with up to 9 months follow-up from the Phase 2 KYSA-6 study of KYV-101 in myasthenia gravis.
When will Kyverna Therapeutics begin the Phase 3 portion of the KYSA-6 trial?
Kyverna plans to initiate the registrational Phase 3 portion by the end of 2025.
What is KYV-101 designed to achieve in myasthenia gravis patients?
KYV-101, a CD19 CAR T-cell therapy, aims to deliver durable drug-free, disease-free remission with a single dose in patients with generalized myasthenia gravis.
Who will present the KYSA-6 trial data at AANEM 2025?
Dr. Srikanth Muppidi will present the data on Wednesday, October 29, 2025, at 11:00 AM PT in San Francisco.
What type of study is the KYSA-6 trial?
KYSA-6 is an open-label, single-arm, multicenter study that has been amended from a Phase 2 trial into a registrational Phase 2/3 study following FDA alignment.
