Ralinepag - (ADVANCE OUTCOMES)

July 29, 2026: United Therapeutics Corporation (NASDAQ: UTHR) announced The Lancet published full results from the pivotal Phase 3 ADVANCE OUTCOMES trial of investigational ralinepag, a once-daily oral prostacyclin IP receptor agonist, in predominantly pre-treated pulmonary arterial hypertension (PAH) patients.

ADVANCE OUTCOMES met its primary endpoint: ralinepag reduced risk of first adjudicated clinical worsening event by 55% vs placebo (HR 0.45; 95% CI 0.33–0.62; p<0.0001). Key secondary endpoints at week 28 also improved vs placebo, including NT-proBNP (24.3% reduction over placebo; p=0.0013) and 6-minute walk distance (+20.4 m placebo-corrected; p=0.0033); odds of achieving clinical improvement increased by 47% (p=0.015). Effects were reported as consistent across subgroups. Safety was consistent with prostacyclin pathway effects (common AEs: headache, diarrhea, nausea, myalgia) with no new safety signals.

Regulatory/filing catalyst: United Therapeutics said it submitted a New Drug Application for ralinepag to the FDA in June 2026; ralinepag is not FDA-approved and remains investigational for PAH. An open-label extension (ADVANCE EXTENSION) is ongoing for completers.