Kyverna Therapeutics Highlights Neuroimmunology CAR T Franchise and Registrational Phase 3 Trial Design in Myasthenia Gravis at Virtual KOL Event
KYV-101 has the potential to deliver durable, drug-free, disease-free remission in myasthenia gravis and set a new treatment standard for stiff person syndrome
Innovative FDA-aligned KYSA-6 Phase 3 trial design for myasthenia gravis supports
clear and rapid path to BLA
Excerpt from the Press Release:
EMERYVILLE, Calif., Aug. 28, 2025 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, will host a virtual KOL event today to highlight its neuroimmunology CAR T franchise in stiff person syndrome (SPS) and myasthenia gravis (MG).
As part of this event, the Company will share details of its Phase 3 clinical trial design in MG; positive longer-term follow-up data from MG and SPS compassionate use patients1 treated with KYV-101; key insights from leading KOLs highlighting the potential of CD19 CAR T-cell therapy in autoimmune diseases; and the initial framework of its neuroimmunology commercial strategy.
“We are proud to highlight our potential first-in-class CAR T-cell therapy that can address the significant unmet needs of patients with autoimmune diseases, beginning with SPS and MG,” said Warner Biddle, Chief Executive Officer of Kyverna. “As part of our efforts to accelerate our neuroimmunology franchise, we’re pleased to share today the details of our innovative, FDA-aligned Phase 3 trial in MG, which we believe offers an efficient and robust design and highlights KYV-101’s differentiated clinical profile. Additionally, as we continue to observe durable treatment outcomes in compassionate use patients treated with KYV-101, we are energized by the potential to bring the first FDA-approved therapy to SPS patients – a progressive and highly debilitating disease with growing prevalence – and to fundamentally change the treatment paradigm in MG by providing durable, drug-free, disease-free remission with a single dose.”
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