MLYS PDUFA Date: lorundrostat Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Dec 22, 2026 · Mineralys Therapeutics, Inc. · Hypertension
Key facts FDA PDUFA target date 2026-12-22
Drug / candidate lorundrostat
Indication Hypertension
Company Mineralys Therapeutics, Inc.
Market-cap tier Mid
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All December 2026 PDUFA dates → 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 Hypertension.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.