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Kyverna Therapeutics Announces Positive Topline Data from Registrational KYSA-8 Trial of Miv-cel (KYV-101) in Stiff Person Syndrome
Landmark results could pave the way for miv-cel to become the first FDA-approved CAR T-cell therapy for autoimmune disease; Company on track to submit BLA for stiff person syndrome in 1H 2026 Miv-cel achieved statistically significant clinical benefit across all primary and secondary endpoints, reversing disability and eliminating immunotherapies after a single dose Miv-cel was generally well-tolerated with no high-grade CRS or ICANS observed SPS is a debilitating, progressive autoimmune disease
About this update from Kyverna Therapeutics, Inc.
[{"type":"image","alt":"Kyverna Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Kyverna Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":120,"url":"https://media.zenfs.com/en/globenewswire.com/6f9f28e393a47bcb20d3d0e1f187b2f0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/NgRte8yTQVY2_NCia6rH2w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE2ODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/6f9f28e393a47bcb20d3d0e1f187b2f0","width":300,"height":120}},"lazy":false},{"type":"text","content":"Landmark results could pave the way for miv-cel to become the first FDA-approved CAR T-cell therapy for autoimmune disease; Company on track to submit BLA for stiff person syndrome in 1H 2026 ","length":191,"tagName":"p"},{"type":"text","content":"Miv-cel achieved statistically significant clinical benefit across all primary and secondary endpoints, reversing disability and eliminating immunotherapies after a single dose","length":191,"tagName":"p"},{"type":"text","content":"Miv-cel was generally well-tolerated with no high-grade CRS or ICANS observed ","length":77,"tagName":"p"},{"type":"text","content":"SPS is a debilitating, progressive autoimmune disease with no FDA-approved therapies","length":84,"tagName":"p"},{"type":"text","content":"Company to host webcast today, December 15, 2025 at 8 am ET","length":59,"tagName":"p"},{"type":"text","content":"EMERYVILLE, Calif., Dec. 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 positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (‘miv-cel’, formerly KYV-101), a fully human, autologous CD19-targeting CAR T-cell therapy with CD28 co-stimulation, in stiff person syndrome (SPS).","length":476,"tagName":"p"},{"type":"text","content":"“We are very pleased to share transformative topline data in stiff person syndrome, which could pave the way for miv-cel to become the first and only approved therapy in SPS and CAR T-cell therapy for autoimmune disease,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “Today’s results further cement our leadership position in the autoimmune CAR T field and add to the growing body of ...