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MLYS PDUFA Date: Lorundrostat

FDA decision (PDUFA) target 2026-12-22 · Mineralys Therapeutics Inc. · Uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).

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

$31.54$22.5
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-22
Drug / candidateLorundrostat
IndicationUncontrolled hypertension (uHTN) or resistant hypertension (rHTN).
CompanyMineralys Therapeutics Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT06153693 · nan

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FAQ

When is the MLYS PDUFA date?
The FDA PDUFA target date for MLYS (Mineralys Therapeutics Inc.) is 2026-12-22 for Lorundrostat. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is MLYS's drug Lorundrostat?
Lorundrostat is Mineralys Therapeutics Inc.'s candidate under FDA review for Uncontrolled hypertension (uHTN) or resistant hypertension (rHTN)..
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.