United Therapeutics says FDA reviews ralinepag NDA for pulmonary arterial hypertension

• 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).

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