United Therapeutics Says FDA Accepted Application for Pulmonary Arterial Hypertension Treatment

08:12 AM EDT, 08/24/2026 (MT Newswires) -- United Therapeutics (UTHR) said Monday the US Food and Drug Administration accepted its new drug application for ralinepag to treat pulmonary arterial hypertension. The regulatory agency set a target action date of June 24, 2027, for the proposed once-daily oral medication. The submission is based on phase 3 trial data showing the drug reduced the risk of clinical worsening by 55% compared with a placebo and met secondary goals for exercise capacity and heart failure biomarkers, it said. Shares of the company were down more than 1% in Monday premarket activity. Price: 513.12, Change: -7.88, Percent Change: -1.51