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Kyverna Therapeutics Announces Initiation of Rolling SPS BLA Submission and Reports First Quarter 2026 Financial Results
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 continue with appointment of Nadia Dac as Chief Commercial Officer Enrollment advances in Phase 3 trial in generalized myasthenia gravis (gMG), further derisked by Phase 2 longer-term follow-up data demon
About this update from Kyverna Therapeutics, Inc.
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 continue with appointment of Nadia Dac as Chief Commercial Officer Enrollment advances in Phase 3 trial in generalized myasthenia gravis (gMG), further derisked by Phase 2 longer-term follow-up data demonstrating durable efficacy out to one year EMERYVILLE, Calif., May 12, 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 reported business and portfolio progress, and financial results for the first quarter ended March 31, 2026. "As the first company to submit a BLA for an autoimmune CAR T therapy, gaining alignment with the FDA on a single-arm trial and a clear path to submission for miv-cel is a significant milestone for not only Kyverna but also the field," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "This achievement underscores both the hard work and dedication of our entire organization and the promising potential of miv-cel, starting with stiff person syndrome. As we execute our rolling BLA submission and prepare for launch in 2027, we are laying the foundation for a multi-indication neuroimmunology franchise that reinforces our leadership position in autoimmune CAR T. More broadly, we are well positioned to establish a new therapeutic paradigm, delivering durable drug-free, disease-free remission for patients." Recent Progress in Neuroimmunology CAR T Franchise In addition, the Company will include additional analysis of its completed natural history study presented at the 2026 American Academy of Neurology (AAN) annual meeting and planned one-year follow-up data from KYSA-8. The natural history data provide context that further reinforces the magnitude of miv-cel’s clinical impact in SPS as a progressive, debilitating disease with significant unmet medical need. The Company has initiated its rolling BLA submission, seeking priority review under the program's Regenerative Medicine Advanced therapy (RMAT) designation, and anticipates completing the submission in Q4 ...
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