Tell me something good, Kyverna Therapeutics announce positive SPS trial data

Kyverna Therapeutics (NASDAQ: KYTX) stock surged 14% Monday after the company announced positive topline data from its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel) in stiff person syndrome (SPS).

The clinical-stage biopharmaceutical company reported that miv-cel achieved statistically significant clinical benefits across all primary and secondary endpoints in the KYSA-8 trial. The therapy demonstrated a 46% median improvement in the timed 25-foot walk test compared to baseline, with 81% of patients exceeding the clinically meaningful threshold of 20% improvement.

Notably, 67% of patients who previously required walking aids no longer needed assistance after treatment, and 100% of patients remained free of immunotherapies following a single dose of the CD19-targeting CAR T-cell therapy.

“We are very pleased to share transformative topline data in stiff person syndrome, which could pave the way for miv-cel to become the first and only approved therapy in SPS and CAR T-cell therapy for autoimmune disease,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics.

The treatment was generally well-tolerated with no high-grade cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome observed. Some patients experienced manageable Grade 3/4 neutropenia, a known side effect of CAR T therapies.