Kyverna 计划于 2026 年上半年提交 miv-cel 的 SPS BLA

该公司宣布计划在 2026 年上半年提交 miv-cel 在僵人综合征的首个 BLA，此前 KYSA-8 试验的注册性数据积极。完整的注册性数据预计也将在 2026 年上半年公布。此次申报由最近的 1.05 亿美元后续公开发行全额资助，现金储备可维持至 2028 年。

关键事实

申报时间: 2026年1月12日 13:00
事件: 申请已提交
方向: 中性
公司: KYTXKyverna
资产: mivocabtagene autoleucel
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 3 kytx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Kyverna Therapeutics Provides Corporate Update and Outlines 2026 Strategic Priorities at the J.P. Morgan Healthcare Conference Advancing valuable commercial opportunity in stiff person syndrome (SPS) following landmark registrational data; Biologics License Application (BLA) submission anticipated in 1H 2026 First patient enrolled in registrational Phase 3 trial in generalized myasthenia gravis (gMG) Completed follow-on offering extends cash runway into 2028, expected to fully fund SPS BLA filing, commercial launch, and Phase 3 gMG trial Kyverna Board member, Christi Shaw, appointed as Executive Chairperson, further bolstering Company’s CAR T commercialization experience; Ian Clark, former Chairperson, to remain on Board EMERYV

SEC 8-K