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MLYS PDUFA Date: Lorundrostat

Updated ·next FDA decision on the calendar
FDA decision (PDUFA) target 2026-12-22 · Mineralys Therapeutics Inc. · Uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).
More Cardiovascular FDA decisions →All December 2026 PDUFA dates →

The story

Lorundrostat is under FDA review to treat Uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). Balance sheet: about 57 months of cash, runway ~57 mo (estimated).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthIONS-olezarsen . 2026-06-30Same area: Metabolic / Cardio . OlezarsenMRK-winrevair . 2026-09-21Same area: Metabolic / Cardio . WINREVAIR (sotatercept-csrk)EXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

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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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · mid-cap cohortn=222 · median -0.0% · 49% up
under -30%: 5 of 222 (2%)<-30-30 to -15%: 6 of 222 (3%)-15 to -7%: 7 of 222 (3%)-7 to -3%: 21 of 222 (9%)-3 to +3%: 134 of 222 (60%)±3+3 to +7%: 34 of 222 (15%)+7 to +15%: 9 of 222 (4%)+15 to +30%: 1 of 222 (0%)over +30%: 5 of 222 (2%)>+30
Distribution of next-day % moves after the FDA decision for mid-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.