United Therapeutics says FDA reviews ralinepag NDA for pulmonary arterial hypertension
UTHR•FDA reviews ralinepag NDA
United Therapeutics filed a New Drug Application with the FDA in June 2026 for ralinepag in pulmonary arterial hypertension.
Phase 3 ADVANCE OUTCOMES met its primary endpoint, cutting clinical worsening risk 55% versus placebo (HR 0.45; p<0.0001).
