Kyverna Therapeutics(US:KYTX) Globenewswire·2026-01-12 13:00Core Insights - Kyverna Therapeutics is advancing its commercial opportunity in stiff person syndrome (SPS) with a Biologics License Application (BLA) submission anticipated in the first half of 2026 [1][4] - The company has enrolled its first patient in a registrational Phase 3 trial for generalized myasthenia gravis (gMG) [1][5] - A follow-on offering has extended the company's cash runway into 2028, which is expected to fully fund the SPS BLA filing, commercial launch, and Phase 3 gMG trial [1][5] Recent Corporate Updates - Kyverna's CEO, Warner Biddle, emphasized the company's strong execution in 2025, positioning it to be first-to-market in SPS and gMG [2] - Christi Shaw has been appointed as Executive Chairperson, enhancing the company's CAR T commercialization experience [2][5] - The company plans to report full registrational data in the first half of 2026 [6] 2026 Strategic Priorities and Anticipated Milestones - The company aims to file the BLA for miv-cel in SPS in the first half of 2026 following positive topline data from the KYSA-8 trial [4] - Kyverna has initiated the Phase 3 registrational trial in gMG, enrolling its first patient in December 2025 [5] - The company raised approximately $105 million in gross proceeds from a public follow-on offering, with estimated cash and equivalents of approximately $279 million as of December 31, 2025 [5] - Kyverna's IND application for KYV-102 was accepted by the U.S. FDA in January 2026 [5] Future Plans - The company plans to achieve SPS launch readiness by the end of 2026 and continue advancing the Phase 3 gMG trial [11] - Kyverna will evaluate additional pipeline opportunities and report Phase 2 investigator-initiated trial data in rheumatoid arthritis and Phase 1 data in multiple sclerosis and lupus nephritis in 2026 [11]