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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
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., March 02, 2026--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its long-term pivotal phase 3 ADVANCE OUTCOMES study met its primary endpoint, with ralinepag reducing the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p<0.0001).
About this update from United Therapeutics Corporation
[{"type":"text","content":"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)","length":254,"tagName":"p"},{"type":"text","content":"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","length":250,"tagName":"p"},{"type":"text","content":"United Therapeutics intends to submit a New Drug Application (NDA) for ralinepag to the U.S. Food and Drug Administration (FDA) by the second half of 2026","length":154,"tagName":"p"},{"type":"text","content":"United Therapeutics will host a webcast at 8:30 a.m. Eastern Time today to further discuss the study results","length":108,"tagName":"p"},{"type":"text","content":"SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., March 02, 2026--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its long-term pivotal phase 3 ADVANCE OUTCOMES study met its primary endpoint, with ralinepag reducing the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p<0.0001).","length":432,"tagName":"p"},{"type":"text","content":"Ralinepag demonstrated durable efficacy in delaying disease progression during the study, in which 80% of patients were on dual background therapy and 70% of patients were considered World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II at baseline.","length":286,"tagName":"p"},{"type":"text","content":"Statistically significant improvements relative to placebo were also observed in important secondary endpoints, including six-minute walk distance (6MWD) and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP), with ralinepag increasing the odds of achieving clinical improvement by 47% from baseline to Week 28 (p=0.015).","length":334,"tagName":"p"},{"type":"text","content":"Benefits were consistent across all patient subgroups, including time since diagnosis, disease etiology, baseline 6MWD, and use of background therapies, reinfor...