Mineralys Therapeutics

MLYS

Market cap $2.57B

RADNOR, Pa., Jan. 06, 2026 (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 issued a corporate update highlighting several recent and upcoming clinical and regulatory milestones.

Mineralys (MLYS) is transitioning to a pre-commercial stage, supported by robust Phase 3 data and a strengthened cash position of $593.6 million. MLYS's lorundrostat demonstrated significant efficacy in lowering systolic blood pressure, with compelling results in both real-world and specialty settings. Regulatory risk is reduced following positive pre-NDA FDA feedback and JAMA recognition, with NDA submission expected late 2025 or early 2026.

Mineralys Therapeutics leads a biotech surge, with four drug stocks up over 50% in 2025 and catalysts lining up for more upside in 2026.

MLYS, LYEL, NKTR and INSM rise more than 50% in 2025 as clinical wins, FDA approvals and M&A deals revive sector momentum heading into 2026.

New York City-based Suvretta Capital Management increased its MLYS position by 387,641 shares in the third quarter. The overall position value increased by $57.25 million from the previous period.

– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impactful of 2025 by JAMA editors –

The mean of analysts' price targets for Mineralys Therapeutics, Inc. (MLYS) points to a 27.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

New York City-based Findell Capital Management added 250,000 shares of MLYS, valued at $9.5 million, in the third quarter. The purchase marked a new position for Findell, which reported holding no shares of MLYS in the previous quarter.

RADNOR, Pa., Nov. 26, 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 that on November 24, 2025, the Compensation Committee of Mineralys' Board of Directors granted an inducement stock option award covering 146,000 shares of Mineralys common stock to one new non-executive employee.

Mineralys Therapeutics, Inc. ( MLYS ) Q3 2025 Earnings Call November 10, 2025 4:30 PM EST Company Participants Jon Congleton - President, CEO & Director Adam Levy - CFO & Secretary David Rodman - Chief Medical Officer Eric Warren Conference Call Participants Daniel Ferry - Lifesci Advisors, LLC Umer Raffat - Evercore ISI Institutional Equities, Research Division Jin Law - Goldman Sachs Group, Inc., Research Division Alice Nettleton - BofA Securities, Research Division Jayed Momin - Stifel, Nicolaus & Company, Incorporated, Research Division Mohit Bansal - Wells Fargo Securities, LLC, Research Division Rami Katkhuda - LifeSci Capital, LLC, Research Division Presentation Operator Greetings, and welcome to Mineralys Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.