Kyverna Therapeutics Inc. (NASDAQ:KYTX) shares jumped 24% after hours to $12.04 Tuesday after releasing positive registrational trial results for miv-cel in stiff person syndrome at the American Academy of Neurology Annual Meeting in Chicago.
Miv-cel, the single-dose CAR T-cell therapy met its primary endpoint, delivering a statistically significant 46% median improvement in the Timed 25-Foot Walk at 16 weeks.
All 26 patients discontinued chronic immunotherapies and 81% achieved a clinically meaningful improvement, with at least a 20% improvement from baseline in walking speed.
No Approved Therapies
Kyverna Therapeutics stated SPS affects roughly 6,000 U.S. patients with no Food and Drug Administration-approved treatments currently available.
CEO Warner Biddle said, “We see compelling evidence that a one-time therapy can reset the immune system, …
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