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pdufa.bio

lorundrostat

Updated ยทnext FDA decision on the calendar

lorundrostat is a Mineralys Therapeutics, Inc. program in Hypertension. Its PDUFA date is Dec 22, 2026, the FDA's goal date to complete review of the application. Every date links its source.

MLYS catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Hypertension. Sponsor: Mineralys Therapeutics, Inc. (MLYS). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 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.

Catalyst history

PDUFA · Dec 22, 2026MLYS

Questions

When is lorundrostat's next FDA decision or readout?

lorundrostat's PDUFA date is Dec 22, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at lorundrostat's most recent FDA decision?

No FDA decision for lorundrostat is in our archive yet.

What is lorundrostat used for?

In our records lorundrostat is under review or in development for Hypertension.

Who makes lorundrostat?

Mineralys Therapeutics, Inc. (MLYS).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.