Kyverna's Miv-cel Shows Durable One-Year Responses in SPS and gMG, BLA on Track for Q4
KYTX sits 36% above its 52-week low of $5.3.
Summary
Kyverna reported positive one-year data from its registrational KYSA-8 trial in stiff person syndrome (SPS) and longer-term follow-up from the Phase 2 portion of KYSA-6 in generalized myasthenia gravis (gMG). In SPS, 95% of patients who achieved clinically meaningful improvement at the primary analysis sustained their benefit, with significant improvements in mobility and 92% remaining free of chronic immunotherapies. In gMG, all 7 patients achieved clinically meaningful improvement at 24 weeks, with responses maintained through one year or longer in all five patients who reached that timepoint. Safety remained clean with no high-grade CRS, ICANS, or IEC-HS. The company confirmed its rolling BLA submission for miv-cel in SPS is on track for completion in Q4 2026, and Phase 3 enrollment in gMG is expected to complete by mid-2027. This follows the RMAT designation and Q2 cash runway into 2028 reported in August. The data strengthen the case for first approval in SPS and first CAR T approval in autoimmune disease, a major value inflection for a $437M market cap company. Full data will be presented at MS Toronto in October and AANEM on September 29.
At the time of this announcement, KYTX was trading at $7.19 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $437.2M. The 52-week trading range was $5.30 to $13.67. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.