原始来源记录
重大申请已提交
Kyverna 计划于 2026 年上半年为 stiff person syndrome 的 miv-cel 提交首份 BLA
该公司宣布，其针对 SPS 的注册性 KYSA-8 2 期试验 miv-cel 已达到所有主要和次要终点，显示出具有统计学意义的临床获益和良好的安全性。Kyverna 现在预计将于 2026 年上半年为 stiff person syndrome 的 miv-cel 提交首份 BLA。
关键事实
- 申报时间
- 2026年3月26日 20:06
- 事件
- 申请已提交
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
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