Welcome to our dedicated page for Mineralys Therapeutics news (Ticker: MLYS), a resource for investors and traders seeking the latest updates and insights on Mineralys Therapeutics stock.
Mineralys Therapeutics, Inc. (MLYS) is a clinical-stage biopharmaceutical company advancing targeted therapies for hypertension, chronic kidney disease, and sleep apnea. This page aggregates official news and press releases, providing investors with essential updates on the company’s progress in developing aldosterone-focused treatments.
Access timely reports on clinical trial milestones, regulatory developments, and strategic partnerships. The curated content includes detailed announcements about lead candidate lorundrostat, a selective aldosterone synthase inhibitor, alongside financial disclosures and market analyses.
Key updates cover:
• Clinical Research: Phase advancements and trial outcomes
• Regulatory Progress: FDA communications and approval pathways
• Corporate Strategy: Collaborations and pipeline expansions
• Financial Updates: Earnings summaries and investment decisions
Bookmark this resource for direct access to primary-source MLYS developments. Visit regularly for objective reporting on innovations in cardiorenal therapeutics.
Mineralys Therapeutics (Nasdaq: MLYS) reported financial results for 2022, announcing a net loss of $29.8 million, up from $19.4 million in 2021. Cash and equivalents increased to $110.1 million following a successful IPO in February, yielding approximately $202 million in net proceeds. The pivotal clinical program for lorundrostat, targeting uncontrolled hypertension, is set to begin in H1 2023. Recent positive Phase 2 trial data supports this initiation, with topline results expected in 2024. Upcoming trials include a Phase 3 study in H2 2023 and a chronic kidney disease trial mid-2023.
Mineralys Therapeutics announced positive results from the Target-HTN Phase 2 trial for lorundrostat, showing a significant placebo-adjusted reduction in systolic blood pressure (BP) of 16.7 mmHg among obese patients (BMI ≥30 kg/m²) at a dose of 50 mg once daily. The trial indicated safety and efficacy in inadequately controlled hypertensive patients on multiple medications. CEO Jon Congleton emphasized the link between obesity, aldosterone, and hypertension, confirming the company's strategic direction. An additional clinical trial is expected to begin in the first half of 2023, enhancing hopes for lorundrostat's market introduction.
Mineralys Therapeutics (NASDAQ: MLYS) announced its plan to release financial results for the fourth quarter ending December 31, 2022, on March 15, 2023, post-market close. A conference call with management is scheduled for 4:30 p.m. ET on the same day, accessible via 1-877-704-4453 (U.S.) or 1-201-389-0920 (international) with conference ID 13736564. The company is focused on developing treatments for diseases linked to high aldosterone levels, with its lead candidate, lorundrostat, targeting uncontrolled hypertension.
Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced the selection of abstracts featuring lorundrostat clinical data from Phase 1 and Phase 2 studies for presentation at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23/WCC) in New Orleans from March 4-6, 2023. The moderated poster, titled “Highly Effective Blood Pressure Lowering with lorundrostat”, will be presented by Dr. David Rodman on March 4. Additionally, a poster presentation titled “First-In-Human Study of lorundrostat” is scheduled for March 5. Lorundrostat is being developed as a treatment for uncontrolled hypertension, demonstrating significant selectivity in inhibiting aldosterone synthesis.