原始来源记录
决策级顶线结果
Alkermes：LUMRYZ在3期IH研究中达到所有终点
REVITALYZ 3期试验显示ESS、PGI-C和IHSS较安慰剂有统计学显著改善。Alkermes计划在2026年底前提交特发性嗜睡症的sNDA。根据此前和解协议，LUMRYZ用于IH的营销限制至2028年3月1日。
关键事实
- 申报时间
- 2026年5月12日 11:07
- 事件
- 顶线结果
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- ess p值
- p<0.0001
- ihss p值
- p<0.0001
- 参与者
- 104例
- pgi c p值
- p<0.0001
来源摘录
EX-99.1 2 alks-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Gretchen Murphy +1 781 609 6419 Alkermes Announces Positive Topline Results From REVITALYZ SM Phase 3 Study Evaluating LUMRYZ ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia – LUMRYZ Met All Primary and Key Secondary Endpoints Demonstrating Statistically Significant and Clinically Meaningful Improvements Compared to Placebo in Excessive Daytime Sleepiness and Patient-Reported Disease Severity – – Safety Profile Consistent With Known Safety Profile of LUMRYZ – DUBLIN, May 12, 2026—Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the REVITALYZ SM double-blind, placebo-controlled, randomized withdrawal, mult