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.
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