原始出處紀錄
重大申請已送件
Kyverna 計劃於 2026 年上半年針對僵人症提交 miv-cel 的首份 BLA
該公司宣布其針對 SPS 的註冊性 KYSA-8 第二期試驗已達成所有主要及次要終點，展現具統計學意義的臨床效益及良好的安全性。Kyverna 現預計於 2026 年上半年針對僵人症提交 miv-cel 的首份 BLA。
關鍵事實
- 申報時間
- 2026年3月26日 下午08:06
- 事件
- 申請已送件
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 kytx-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Kyverna Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results Advancing first-to-market autoimmune CAR T opportunity in stiff person syndrome (SPS) with key launch preparation activities underway; BLA submission anticipated in 1H 2026 Progressing enrollment for FDA-aligned Phase 3 trial in generalized myasthenia gravis (gMG) Positive progressive multiple sclerosis data underscore valuable pipeline-in-a-product opportunity with miv-cel Cash and cash equivalents of $279 million provide expected runway into 2028, funding SPS BLA filing, commercial launch, and Phase 3 gMG trial EMERYVILLE, Calif., March 26, 2026 – Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopha