原始出處紀錄
決策級主要結果 (Topline)
United Therapeutics：ralinepag 在第三期試驗中降低 PAH 惡化風險 55%
The ADVANCE OUTCOMES Phase 3 trial met its primary endpoint, showing a 55% reduction in clinical worsening events versus placebo. United Therapeutics plans to file an NDA for ralinepag in H2 2026, positioning the once-daily oral prostacyclin as a potential new standard of care in PAH.
關鍵事實
- 申報時間
- 2026年3月2日 上午11:32
- 事件
- 主要結果 (Topline)
- 方向
- 正面
- 來源
- SEC 8-K
- 可信度
- 有出處
- p值
- <0.0001
- WHO功能等級II
- 70%
- 風險比
- 0.45
- 風險降低
- 55%
- 接受雙重療法患者
- 80%
- 臨床改善勝算
- 47%
來源摘錄
EX-99.1 2 tm267696d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 United Therapeutics Corporation Announces Ralinepag Achieved 55% Reduction in Risk of Clinical Worsening in Pivotal Pulmonary Arterial Hypertension Study, Delivering Exceptional, Highly Statistically Significant Efficacy The phase 3 ADVANCE OUTCOMES study of ralinepag met its primary endpoint and several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension ( PAH ) Ralinepag has the potential to redefine the PAH treatment landscape as the first and only once-daily oral prostacyclin, combining potent receptor affinity with continuous exposure to deliver long-term, durable efficacy and disease-mitigating outcomes United T