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United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial Hypertension

UTHR
  • United Therapeutics Corporation announced that the U.S. FDA accepted the New Drug Application (NDA) for ralinepag to treat pulmonary arterial hypertension (PAH).
  • The FDA has established a Prescription Drug User Fee Act target action date of June 24, 2027.
  • Ralinepag remains investigational & is not currently approved by the FDA for any indication.
  • The drug is a once-daily oral prostacyclin receptor agonist with the potential to offer continuous exposure & durable efficacy.
  • The filing was based on the phase 3 ADVANCE OUTCOMES study involving 687 patients with PAH.
  • Ralinepag achieved a statistically significant 55% reduction in the risk of clinical worsening compared to placebo.
  • Secondary endpoints showed statistical significance, including reduced NT-proBNP levels, improved six-minute walk distance, & a 47% increase in the odds of clinical improvement.
  • The safety profile was consistent with known prostacyclin-related adverse events with no new safety signals observed.
  • Clinical trial data were presented at the 2026 American Thoracic Society annual meeting & published in The Lancet.
  • Ralinepag demonstrates six-fold higher binding affinity for the IP receptor than selexipag's active metabolite.
  • PAH is a life-threatening disease affecting approximately 50,000 individuals in the United States & 500,000 globally.
  • This press release was issued on August 24, 2026, & includes forward-looking statements regarding the FDA review process.