Mineralys Therapeutics

MLYS

Market cap $3.38B

Mineralys Therapeutics, Inc. advances lorundrostat, its lead aldosterone inhibitor, for uncontrolled and resistant hypertension with pivotal Phase 3 successes. Mineralys achieved positive Phase 2 results in CKD patients with hypertension, supporting NDA submission and expanding lorundrostat's potential patient base. A pre-NDA meeting with the FDA is set for Q4 2025, with additional Phase 2 data in OSA-hypertension expected in Q1 2026 as further catalysts.

~ Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 ~ RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in its Phase 2 EXPLORE-OSA trial of lorundrostat in participants with moderate-to-severe OSA and hypertension.

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~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~

RADNOR, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today the closing of its previously announced underwritten public offering of 11,274,509 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase up to 1,470,588 additional shares of its common stock, at a public offering price of $25.50 per share. The aggregate gross proceeds to Mineralys from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $287.5 million. All of the securities sold in the offering were sold by Mineralys.