Kyverna 計劃於 2026 年上半年提交 miv-cel 的 SPS BLA

該公司宣布計劃在 2026 年上半年提交 miv-cel 用於僵人症候群的第一份 BLA，此舉是在 KYSA-8 試驗獲得正面註冊性數據之後。完整的註冊性數據預計也將於 2026 年上半年公布。此次申請已由近期 1.05 億美元的後續增發全額資助，現金流可延續至 2028 年。

關鍵事實

申報時間: 2026年1月12日下午01:00
事件: 申請已送件
方向: 中性
公司: KYTXKyverna
資產: mivocabtagene autoleucel
來源: SEC 8-K
可信度: 有出處

來源摘錄

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