Jazz Pharmaceuticals：Modeyso（dordaviprone）获FDA加速批准，用于复发性H3 K27M突变型DMG

FDA于2025年8月6日授予Modeyso（dordaviprone）加速批准，早于其PDUFA日期，使其成为复发性H3 K27M突变型弥漫性中线胶质瘤的首个也是唯一靶向疗法。Jazz立即启动商业化上市，并在2025年第三季度报告销售额1100万美元。该药物还被纳入NCCN临床实践指南。

关键事实

申报时间: 2025年11月5日 21:07
事件: FDA 批准
方向: 积极
公司: JAZZJazz Pharmaceuticals
资产: dordaviprone
来源: SEC 8-K
可信度: 有来源
3q25销售额: 1100万美元

来源摘录

EX-99.1 2 a3q25financialpr.htm EX-99.1 Document Exhibit 99.1 Jazz Pharmaceuticals Announces Third Quarter 2025 Financial Results and Updates 2025 Financial Guidance – Modeyso™ approved as the first and only treatment for recurrent H3 K27M-mutant DMG – – Zepzelca ® and atezolizumab (Tecentriq ® ) combination approved as maintenance therapy in 1L ES-SCLC – – 3Q25 total revenues increased 7% year-over-year driven by robust growth of Epidiolex ® , Xywav ® and the launch of Modeyso – DUBLIN, November 5, 2025 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the third quarter of 2025 and updated financial guidance for 2025. “Achieving the highest revenue quarter in Jazz's history speaks to the strength of our diversified portfolio and the outstanding performa

SEC 8-K