United Therapeutics Corporation reported that its long-term pivotal phase 3 ADVANCE OUTCOMES study in pulmonary arterial hypertension met its primary endpoint, with oral ralinepag reducing the risk of a clinical worsening event by 55% versus placebo (hazard ratio 0.45; 95% CI 0.33–0.62; p<0.0001). The company said statistically significant improvements were also observed in secondary endpoints including six-minute walk distance and NT-proBNP, and that the safety profile was consistent with known prostacyclin-related adverse events. United Therapeutics stated that full results will be presented at an upcoming international conference and that it plans to submit a New Drug Application to the FDA in the second half of 2026.

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