Savara 提交 MOLBREEVI 治疗自身免疫性 PAP 的 BLA

Savara 于 2025 年 12 月向 FDA 提交了 MOLBREEVI（莫拉莫司汀吸入溶液）治疗自身免疫性肺泡蛋白沉着症的 BLA。该申请基于积极的 3 期 IMPALA-2 研究结果，该研究显示在第 24 周和第 48 周，DLco% 较安慰剂有统计学意义的改善，耐受性良好且 100% 开放标签 rollover。

关键事实

申报时间: 2026年1月9日 13:00
事件: 申请已提交
方向: 中性
公司: SVRASavara
资产: molgramostim
来源: SEC 8-K
可信度: 有来源

来源摘录

EX-99.1 2 d24211dex991.htm EX-99.1 EX-99.1 Corporate Overview January 2026 Developing new therapies for rare respiratory diseases Exhibit 99.1 Safe Harbor Statement © Savara Inc. All Rights Reserved. Savara Inc. (“Savara” or the “Company”) cautions you that statements in this presentation that are not a description of historical fact are forward-looking statements which may be identified by the use of words such as “expect,” “intend，” “plan，” “anticipate，” “believe，” and “will，” among others. Such statements include, but are not limited to, statements regarding the potential health benefits and risks and projected development timeline of MOLBREEVI; the timing of regulatory submissions; the potential for and impact of regulatory approval; the potential addressable patient population, mar

SEC 8-K