原始来源记录
决策级PDUFA 日期确定
Rhythm将setmelanotide用于获得性下丘脑肥胖(HO)的sNDA的PDUFA日期定为2026年3月20日
FDA accepted the sNDA for setmelanotide in acquired hypothalamic obesity and assigned a PDUFA goal date of March 20, 2026. Additional 52-week data from the TRANSCEND trial (N=142) showed an 18.8% placebo-adjusted BMI reduction, reinforcing the pivotal dataset. The company will submit the final data package on March 2, 2026.
关键事实
- 申报时间
- 2026年3月2日 11:01
- 事件
- PDUFA 日期确定
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年3月20日 · 积极
- 安慰剂组平均BMI变化
- +2.4%
- 安慰剂组饥饿评分降低
- 1.3分
- 安慰剂校正BMI降低
- -18.8%
- setmelanotide平均BMI降低
- -16.4%
- setmelanotide饥饿评分降低
- 2.5分
来源摘录
EX-99.1 2 tm267699d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity -- - 18.8% placebo-adjusted difference in BMI reduction achieved in all patients (N=142) at 52 weeks, including 12 Japanese patients and 10 supplemental patients with acquired hypothalamic obesity -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- BOSTON, March 1, 2026 – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced additional positive data from its global Phase 3 TRANSCEND trial
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决策级
2025年11月7日
13:09
RYTMRhythm