FDA Accepts United Therapeutics' NDA Filing for Ralinepag in PAH

United Therapeutics announced FDA acceptance of its NDA for ralinepag, a once-daily oral prostacyclin receptor agonist for pulmonary arterial hypertension (PAH). The Phase III ADVANCE OUTCOMES study showed ralinepag reduced clinical worsening risk by 55% versus placebo and improved secondary endpoints. If approved in June 2027, it would be the first once-daily oral prostacyclin for PAH, complementing UTHR's existing PAH portfolio.