Lorundrostat PDUFA date: FDA decision expected December 22, 2026

The FDA is expected to decide on Lorundrostat from Mineralys Therapeutics, Inc. in Obstructive Sleep Apnea by the PDUFA target action date of December 22, 2026. Mineralys outlined U.S. launch plans for lorundrostat ahead of the December 22, 2026 PDUFA decision date.

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.