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MRK PDUFA Date: WINREVAIR (sotatercept-csrk)

FDA decision (PDUFA) target 2026-09-21 · Merck & Company Inc. · Pulmonary arterial hypertension (PAH, WHO* Group 1)

MRK run-up into the PDUFA (last ~120 days)

$123.93$109.18
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-21
Drug / candidateWINREVAIR (sotatercept-csrk)
IndicationPulmonary arterial hypertension (PAH, WHO* Group 1)
CompanyMerck & Company Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04811092 · nan

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FAQ

When is the MRK PDUFA date?
The FDA PDUFA target date for MRK (Merck & Company Inc.) is 2026-09-21 for WINREVAIR (sotatercept-csrk). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is MRK's drug WINREVAIR (sotatercept-csrk)?
WINREVAIR (sotatercept-csrk) is Merck & Company Inc.'s candidate under FDA review for Pulmonary arterial hypertension (PAH, WHO* Group 1).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.