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Kyverna Therapeutics reported strong clinical data for its autoimmune CAR T therapy miv-cel (KYV‑101) in two registrational programs, stiff person syndrome (SPS) and generalized myasthenia gravis (gMG). The results were highlighted in a presentation tied to a conference call and recent press releases.
In the SPS Phase 2 KYSA‑8 registrational trial (n=26), patients had a 46% median improvement in the timed 25‑foot walk at week 16, with 81% achieving at least a 20% improvement and all remaining off SPS immunomodulatory or immunosuppressive therapies through last follow‑up. Secondary measures of disability, stiffness, and hypersensitivity all improved significantly, and no high‑grade cytokine release syndrome (CRS) or ICANS occurred.
In the gMG Phase 2 KYSA‑6 trial (n=7), a single miv‑cel dose produced rapid, durable reductions in MG‑ADL and QMG scores out to 52 weeks, with 100% of patients achieving clinically meaningful responses and 57% reaching minimal symptom expression. All patients were free of immunotherapies through 24 weeks, with a favorable safety profile and evidence of deep B‑cell depletion, autoantibody reduction, and preserved humoral immunity. The company is preparing a BLA for SPS and advancing a global Phase 3 trial in gMG.
Kyverna Therapeutics reported positive primary analysis results from its registrational Phase 2 KYSA-8 trial of miv-cel (KYV-101) in stiff person syndrome (SPS). A single dose of 1×108 CAR T cells in 26 patients led to rapid, statistically significant and clinically meaningful improvements in walking speed, disability, stiffness, hypersensitivity, and mobility at 16 weeks, with a median 46% improvement in the Timed 25-Foot Walk and 81% of patients achieving at least a 20% improvement.
All patients discontinued chronic immunotherapies by Week 16, and two-thirds of those who needed walking aids at baseline no longer required them. Miv-cel showed a favorable safety profile with no high-grade CRS or ICANS and manageable Grade 3/4 neutropenia, supporting Kyverna’s plans to prepare a BLA submission for SPS.
Kyverna Therapeutics reported longer-term Phase 2 data from its KYSA-6 registrational trial of miv-cel (KYV-101) in generalized myasthenia gravis. Seven patients with moderate-to-severe disease received a single dose, showing deep, durable responses across key clinical scores and reduced treatment burden.
At 24 weeks, all patients had rapid, clinically meaningful improvements in MG-ADL and QMG scores, with many maintaining benefits out to 52 weeks. All were free of nonsteroidal immunosuppressants, high-dose steroids, and FcRn or complement inhibitors at 24 weeks, and safety was favorable with no high-grade CRS or ICANS.
KYTX filed a Form 144 reporting a proposed sale of 10,000 common shares following an exercise of stock options, dated 04/17/2026. The filing lists an aggregate figure of $95,300.00 and identifies Morgan Stanley Smith Barney LLC as the broker on NASDAQ. The filing also discloses recent 10b5-1 sales by Karen Walker of 2,459 shares on 04/14/2026 for $22,889.11.
Kyverna Therapeutics calls a fully virtual 2026 annual meeting on May 27, 2026, asking stockholders to elect two Class II directors, Ian Clark and Christi Shaw, and ratify BDO USA as auditor for 2026.
The proxy highlights 2025 as a transformative year, with registrational data in stiff person syndrome supporting a planned BLA filing in the first half of 2026, strong Phase 2 results in generalized myasthenia gravis backing an FDA‑aligned Phase 3 trial, early signals in multiple sclerosis and rheumatoid arthritis, and a strengthened balance sheet extending cash runway into 2028.
KYTX filed a Form 144 reporting the proposed sale of 17,578 shares of Common Stock via a stock option exercise to be effected on 04/07/2026 for cash. The filing also discloses a prior sale of 16,634 shares on 03/31/2026 for $140,404.27.
Kyverna Therapeutics has registered up to $100,000,000 of its common stock for sale in an at‑the‑market offering through Jefferies LLC acting as sales agent. Sales may occur from time to time under a Sales Agreement dated March 27, 2025, with Jefferies receiving a 3.0% commission on gross proceeds.
The prospectus shows 60,389,893 shares outstanding as of December 31, 2025 and gives an illustrative example of selling 12,594,458 shares at an assumed price of $7.94 per share resulting in up to 72,984,351 shares outstanding. Net proceeds are intended for general corporate purposes, including R&D, capital expenditures, working capital and general administrative expenses.