The application was evaluated based on the positive clinical outcomes of KYV-101 in patients treated in Germany under a named-patient treatment option The Regenerative Medicine Advanced Therapies ...

Kyverna Therapeutics looks all the more likely to win the first FDA approval for a CAR-T therapy in an autoimmune disease after a registrational trial showed “highly statistically significant” ...

This IND clearance expands the use of KYV-101 CAR T-cell therapy in a Phase 2, open-label KYSA-8 clinical trial targeting a devastating neuroimmunological autoimmune disease KYV-101 is a fully human ...

Enrollment complete in registrational Phase 2 KYV-101 trial in stiff person syndrome (SPS); on track for topline data in 1H 2026; biologics license application (BLA) filing now anticipated in 1H 2026 ...

(MENAFN- GlobeNewsWire - Nasdaq) 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 ...

About 100 days into the CEO role at Kyverna Therapeutics, Warner Biddle has determined the strategic priorities for the California biotech, which aims to deliver the first approved CAR-T therapy in an ...

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 ...

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 ...