Kyverna Therapeutics, Inc.

Kyverna Therapeutics Highlights Promising Updated Clinical Data with Miv-cel in Progressive Multiple Sclerosis at MS Toronto 2026

Kyverna presented updated Phase 1 data on miv-cel in progressive multiple sclerosis at the joint ACTRIMS-ECTRIMS meeting in Toronto, showing all five evaluable patients with stable or improved EDSS disability scores. Four patients with over a year of follow-up sustained improvement without chronic immunotherapies, the first treated patient has durable benefit beyond two years, and safety was clean with no high-grade CRS and no ICANS or IEC-HS cases. Miv-cel also received an RMAT designation for non-active secondary progressive MS -- its third -- with a development strategy update expected by early 2027. The data are early-phase, small, and investigator-initiated, so they are proof of concept rather than registrational evidence, but they de-risk the neuroimmunology franchise alongside ongoing registrational trials in SPS and gMG.

•17d ago

Kyverna Therapeutics Presents Full One-Year Registrational Data Set Demonstrating Sustained Clinical Benefit of Miv-cel in Stiff Person Syndrome at MS Toronto

Kyverna presented full one-year registrational data for miv-cel in stiff person syndrome at the ACTRIMS-ECTRIMS joint meeting, showing durable efficacy with T25FW improvement of 49% at one year and 92% of patients remaining free of chronic immunotherapies. Safety remained well-tolerated, with no high-grade CRS, ICANS, or IEC-HS cases in one-year follow-up; grade 3/4 neutropenia occurred in five patients and serious treatment-related AEs in three, all fully resolved. The data strengthen the SPS BLA package and support miv-cel's potential to become the first approved therapy for SPS and the first approved CAR T-cell therapy for autoimmune disease.

•19d ago

Kyverna Therapeutics to Present Positive Data in Stiff Person Syndrome and Progressive Multiple Sclerosis at MSToronto2026

Kyverna Therapeutics will present one-year KYSA-8 registrational data in stiff person syndrome at MSToronto2026, showing sustained clinical benefit with no high-grade CRS, ICANS, or IEC-HS. Updated Phase 1 investigator-initiated data in progressive multiple sclerosis continues to show encouraging activity with a well-tolerated safety profile. Management said it expects to complete the miv-cel BLA submission in SPS this quarter, positioning the therapy as potentially the first CAR T-cell therapy approved for autoimmune disease.

•1mo ago

Kyverna Therapeutics Reports Positive One-Year Data Demonstrating Durable Clinical Responses and Favorable Safety Profile for Miv-cel in Stiff Person Syndrome and Generalized Myasthenia Gravis

Kyverna reported positive one-year durability data from the KYSA-8 registrational trial of miv-cel in stiff person syndrome, with median T25FW improvement sustained at 49% at month 12 and 92% of patients free of chronic immunotherapies. Longer-term Phase 2 gMG data (KYSA-6) showed all 7 patients achieved co-primary endpoint improvements at 24 weeks, with 86% off immunosuppressants at last follow-up and effects sustained up to 1.5 years. Safety remained clean with no high-grade CRS, ICANS, or IEC-HS. The rolling BLA for SPS remains on track for completion in Q4 2026, with Phase 3 gMG enrollment expected to finish by mid-2027.

•1mo ago

Kyverna Therapeutics Reports Pipeline Progress and Second Quarter 2026 Financial Results

Kyverna announced that the FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) and confirmed it is on track to complete a rolling BLA submission for stiff person syndrome in Q4 2026. Financial results showed cash and marketable securities of $199.4 million as of June 30, 2026, which is expected to fund operations into 2028; Q2 net loss was $38.3 million with R&D expenses of $24.8 million. The company strengthened its executive team with the appointments of Greg Martini as CFO, Nadia Dac as CCO, and Ritesh Srivastava as CLO to support commercialization efforts.

•2mo ago

Kyverna Therapeutics and ElevateBio Enter into Commercial Manufacturing and Supply Agreement for Miv-cel

Kyverna Therapeutics entered a commercial manufacturing and supply agreement with ElevateBio for miv-cel, its autologous CD19-directed CAR T-cell therapy candidate. The deal ensures scalable supply for potential launches in stiff person syndrome and generalized myasthenia gravis, supported by ElevateBio’s demonstrated clinical manufacturing success rate of over 98%. Kyverna remains on track to complete its rolling BLA submission for miv-cel in SPS in the fourth quarter of 2026.

•3mo ago

Kyverna Therapeutics Appoints Ritesh Srivastava as Chief Legal and Compliance Officer, Adding Leadership Strength to Support Commercial-Stage Transition

Kyverna Therapeutics appointed Ritesh Srivastava as Chief Legal and Compliance Officer to strengthen leadership as it prepares for the commercialization of its lead asset, miv-cel. Mr. Srivastava joins from BPGbio and previously served as Global Compliance Officer at Spectrum Pharmaceuticals, bringing extensive experience in corporate governance and regulatory compliance. In connection with his appointment, Mr. Srivastava received an inducement option grant to purchase 260,000 shares of common stock.

•4mo ago

Kyverna Therapeutics Highlights Updated Miv-cel Data at EULAR Demonstrating Substantial Reduction in Disease Activity in ACPA-Positive, Treatment Refractory Rheumatoid Arthritis

Kyverna Therapeutics presented updated Phase 1 data from the COMPARE trial for miv-cel in treatment-refractory rheumatoid arthritis at the EULAR 2026 Congress. The data showed that 66.6% of the six heavily pre-treated patients achieved ACR70 response by Week 36, with deep B-cell depletion and evidence of an immune reset. The safety profile was well-tolerated with no high-grade cytokine release syndrome or neurotoxicity, supporting the initiation of the fully enrolled Phase 2 portion of the trial.

•5mo ago

Kyverna Therapeutics Names Greg Martini as Chief Financial Officer

Kyverna Therapeutics appointed Greg Martini as Chief Financial Officer, effective May 18, 2026, succeeding Dr. Marc Grasso. Martini joins from Ironwood Pharmaceuticals, where he served as SVP and CFO, bringing deep expertise in capital allocation and commercial-stage growth. The appointment coincides with Kyverna’s advance of its lead asset miv-cel toward potential first approval in stiff person syndrome and its transition to a commercial-stage organization. As an inducement for employment, Martini received an option to purchase 325,000 shares of common stock, vesting over four years.

•5mo ago

Kyverna Therapeutics Appoints Nadia Dac, Seasoned Commercial Leader in Neurology and Rare Disease, as Chief Commercial Officer

Kyverna Therapeutics appointed Nadia Dac as Chief Commercial Officer, effective May 4, to lead commercial strategy for its lead asset miv-cel in preparation for a potential first approval in stiff person syndrome. Ms. Dac brings over 30 years of experience, having previously led commercial launches at Omeros Corporation and Alder Biopharmaceuticals, and will focus on building Kyverna's neuroimmunology franchise. In connection with the appointment, Kyverna granted Ms. Dac an inducement option to purchase 300,000 shares of common stock, vesting over four years.

•6mo ago

Kyverna Presents Registrational Trial Primary Analysis for Miv-cel in Stiff Person Syndrome Demonstrating Statistically Significant, Durable Clinical Benefit Across All Endpoints in an Oral, Late-Breaker Session at AAN Annual Meeting

Kyverna reported positive primary analysis from its registrational KYSA-8 trial of miv-cel in stiff person syndrome, demonstrating statistically significant improvements across all primary and secondary endpoints. A single dose of miv-cel achieved a median 46% improvement in walking speed at 16 weeks (p=0.0003), with all 26 patients discontinuing chronic immunotherapies. The therapy was well-tolerated with no high-grade cytokine release syndrome or neurotoxicity, and the company is preparing a BLA submission for this indication.

•6mo ago