As of Oct 26, 2026: Mineralys Therapeutics (MLYS) has a PDUFA date for lorundrostat on Dec 22, 2026, in 57 days. Its Quality Score is -5. Scores as of 9:21 PM ET, 15 minutes behind.

MLYS FDA decision on Lorundrostat

Mineralys Therapeutics · PDUFA date

PDUFA dateDec 22in 57 days Quality Score-5Poor

Cash runway–into 2028

What the company said

“PDUFA target date of December 22, 2026 for lorundrostat”

PDUFA date, Dec 22, 2026. As Mineralys Therapeutics stated in its 8-K of Aug 11, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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