This page aggregates MLYS's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.
December 22, 2026. The next catalyst for Mineralys Therapeutics, Inc. is lorundrostat Dose 1 (PDUFA). That date is a confirmed date. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.
Measured from this company's own daily closing prices: Since its T-120 baseline on 2026-07-02 ($27.69), MLYS is -7.5% to $25.60 at the close on 2026-08-28. The highest close since that baseline is +10.0% above it. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.
FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.