Kyverna stock jumps on positive one-year therapy data

Investing.com -- Kyverna Therapeutics Inc (NASDAQ: KYTX) shares rose nearly 10% in early trade Thursday following the release of positive one-year durability data for its miv-cel therapy in stiff person syndrome and generalized myasthenia gravis.

The company reported that sustained clinical benefit and reversal of disability through one year support the potential for miv-cel to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune disease. The rolling BLA submission remains on track for completion in the fourth quarter of 2026.

For the KYSA-6 Phase 2 trial in gMG, follow-up data extending up to 1.5 years showed all seven patients achieved clinically meaningful improvement in disease measures at 24 weeks. Clinically meaningful improvements were maintained through one year or longer in all five patients who reached this time point, with 57% of patients maintaining minimal symptom expression.

The therapy continued to demonstrate a well-tolerated safety profile across both trials, with no high-grade cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, and no cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome in one-year follow-up.

The Phase 3 portion of the KYSA-6 trial is ongoing, with enrollment expected to be completed in mid-2027. The full SPS data set will be presented at the joint ACTRIMS-ECTRIMS meeting in Toronto in October 2026.

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