Kyverna Therapeutics Stock Up 41% in a Month: Here's Why

Core Insights - Kyverna Therapeutics is developing mivocabtagene autoleucel (miv-cel) as a CAR T-cell therapy for stiff person syndrome (SPS), a rare autoimmune disease with no FDA-approved treatments, potentially making it the first CAR T therapy approved for an autoimmune condition [1][4] Group 1: Study Results - Positive top-line data from the pivotal phase II study indicated that miv-cel achieved statistically significant and sustained improvements in overall disability, mobility, and stiffness in SPS patients [2] - The study met all primary and secondary endpoints, with a median improvement of 46% in the timed 25-foot walk (T25FW) test, which assesses walking ability and mobility [3][9] Group 2: Future Plans - Kyverna plans to file a biologics license application (BLA) for miv-cel in the first half of 2026, aiming for FDA approval as the first therapy for SPS [4][9] - The company is also conducting a phase II/III study for miv-cel in generalized myasthenia gravis (gMG), with interim data showing potential for durable, drug-free remission [7] Group 3: Financial Developments - In November, Kyverna secured a loan facility of up to $150 million with Oxford Finance, enhancing its financial flexibility for ongoing pipeline development [10]