Upcoming FDA decision · December 31, 2026
Lorundrostat PDUFA date: FDA decision expected December 31, 2026
139 days to goMineralys Therapeutics, Inc. (MLYS) →
The FDA is expected to decide on Lorundrostat from Mineralys Therapeutics, Inc. in Obstructive Sleep Apnea by the PDUFA target action date of December 31, 2026. AI-extracted from news: Mineralys outlines lorundrostat U.S. launch plans ahead of December 22, 2026 PDUFA
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
December 31
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations