WINREVAIR (sotatercept-csrk) is a Merck & Co., Inc. program in Recently diagnosed pulmonary arterial hypertension (label update). Its next catalyst is a PDUFA on Sep 21, 2026. 1 FDA decision on record below. Every date links its source.
Indication under review: Recently diagnosed pulmonary arterial hypertension (label update). Sponsor: Merck & Co., Inc. (MRK). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 1 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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