FDA grants RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data, further expanding the therapy’s potential across neuroimmunology On track to complete rolling BLA submission for miv-cel in stiff person syndrome (SPS) in Q4
New agreement secures flexible and scalable manufacturing to support the U.S. commercial and global clinical supply of miv-cel EMERYVILLE, Calif., and WALTHAM, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company
EMERYVILLE, Calif., June 22, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the appointment of Ritesh Srivastava as Chief Legal and Compliance
Majority of patients met the American College of Rheumatology improvement criteria (ACR70) response by Week 36 Single-dose of miv-cel delivered deep B-cell depletion with evidence of immune reset Miv-cel continues to demonstrate a well-tolerated safety profile, consistent with observations from
Veteran biopharma leader joins to help lead Kyverna’s next phase of commercial growth EMERYVILLE, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases,
EMERYVILLE, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that company management will present at the following upcoming
Positive pre-BLA meeting with FDA alignment reached on KYSA-8 single-arm trial in stiff person syndrome (SPS); rolling BLA submission initiated Miv-cel pivotal trial primary analysis results in SPS demonstrated robust, durable effect in indication with no approved therapies; launch preparations
Ms. Dac brings more than 30 years of experience successfully executing product launches and scaling commercial organizations for a range of therapeutic areas EMERYVILLE, Calif., May 04, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical
Single-dose of miv-cel achieved robust and durable improvements in mobility, reversed disability scores, and eliminated the need for chronic immunotherapies – outcomes not previously observed in SPS Data underscore potential for miv-cel to become the first and only approved treatment for SPS,
100% of patients achieved rapid, sustained improvements across MG-ADL and QMG at 24 weeks, further increasing confidence in Phase 3 trial Totality of efficacy and safety data reinforces miv-cel’s differentiated and potential best-in-class profile for delivering durable, drug-free, disease-free
EMERYVILLE, Calif., April 09, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Kyverna, Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced it will host a conference call on Wednesday, April
Advancing first-to-market autoimmune CAR T opportunity in stiff person syndrome (SPS) with key launch preparation activities underway; BLA submission anticipated in 1H 2026 Progressing enrollment for FDA-aligned Phase 3 trial in generalized myasthenia gravis (gMG) Positive progressive multiple
Late-breaking oral presentation to feature primary analysis from KYSA-8 registrational trial in stiff person syndrome (SPS) Oral presentation on updated KYSA-6 Phase 2 data in generalized myasthenia gravis (gMG) EMERYVILLE, Calif., March 05, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc.
EMERYVILLE, Calif., March 03, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced that company management will participate in the following upcoming