FDA Accepts New Drug Application for Ralinepag in Pulmonary Arterial Hypertension

United Therapeutics Corporation announced the FDA has accepted its New Drug Application (NDA) for ralinepag, an investigational once-daily oral prostacyclin receptor agonist, for pulmonary arterial hypertension (PAH). The application is supported by positive Phase 3 ADVANCE OUTCOMES trial data, which demonstrated a 55% reduction in the risk of clinical worsening. This acceptance marks a key step towards potential market approval for a new PAH treatment.