Mineralys outlines December 22 PDUFA timeline while funding lorundrostat launch into 2028 (NASDAQ:MLYS)

Mineralys Therapeutics reported a 3Q 2026 net loss of $57.3M, up 55.2% YoY, with no revenue. Loss per share was $0.64. The FDA accepted lorundrostat's hypertension NDA, setting a PDUFA date for December 22, 2026. The company is preparing for a potential launch.

Mineralys Therapeutics, Inc. (MLYS) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Mineralys Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update – Commercialization plans for lorundrostat are on track ahead of PDUFA target date of December 22, 2026 – – New analyses from the pivotal Launch-HTN trial showed 46% of

Mineralys Therapeutics reports Q3 earnings with an expected loss of $0.75 per share, an improvement from the prior quarter. Analysts maintain a Strong Buy rating with a mean price target of $45.22. The FDA decision on its lead drug, lorundrostat, is expected by December 22, 2026, which is a key catalyst for the company. The stock is trading near its 52-week low at $15.99.

Small-cap stocks have seen a pullback after a strong first half of 2026, with the Russell 2000 down 11% from its August high. Earnings growth remains robust, with Russell 2000 EPS up 43% in Q2. Analysts highlight five small-cap stocks with strong buy ratings and significant upside potential, including National Energy Services Reunited Corp. (NESR), Applied Aerospace & Defense, Inc. (AADX), and Mineralys Therapeutics, Inc. (MLYS).

Mineralys Therapeutics (MLYS) reported Phase 2 trial results for Lorundrostat in chronic kidney disease patients, showing significant blood pressure reduction and kidney damage markers improvement. The drug is being evaluated for high blood pressure and related conditions. MLYS stock is currently at $21.09, down 0.21%.

Mineralys Therapeutics (NASDAQ: MLYS) reported positive Phase 2 trial results for lorundrostat in Kidney International. The trial met its primary endpoint, reducing systolic blood pressure by 7.5 mmHg more than placebo. The company submitted a new drug application to the FDA. The trial involved 59 participants with uncontrolled hypertension and chronic kidney disease.