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. (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Company news frequently centers on clinical trial milestones, regulatory interactions and scientific recognition related to hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other conditions driven by dysregulated aldosterone.
News updates from Mineralys describe progress across a broad clinical program. These include topline and subgroup results from the pivotal Launch-HTN Phase 3 trial in uncontrolled or treatment-resistant hypertension, data from the Advance-HTN trial, and long-term follow-up in the Transform-HTN open-label extension. Additional coverage highlights Phase 2 studies such as Explore-CKD, which evaluated lorundrostat in participants with hypertension, CKD and albuminuria, and Explore-OSA, a trial in overweight or obese adults with moderate-to-severe OSA and hypertension.
Investors and observers can also find announcements about regulatory steps, such as plans for and filing of a New Drug Application (NDA) for lorundrostat with the U.S. Food and Drug Administration, as well as public equity offerings and other financing activities disclosed in SEC filings and press releases. Mineralys regularly reports on participation in major medical and scientific meetings, where data from Launch-HTN and Explore-CKD have been featured in sessions and roundups by organizations such as the American Society of Nephrology and the Journal of the American Medical Association.
This news feed aggregates these developments so readers can follow Mineralys Therapeutics’ clinical, regulatory, financial and corporate communications over time, with a particular focus on the evolving evidence base for lorundrostat in hypertension and related comorbidities.
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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.
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, has successfully closed its initial public offering (IPO) of 13,800,000 shares of common stock at an offering price of $16.00 per share. This IPO raised $220.8 million in gross proceeds, including the full exercise of the underwriters' option to purchase an additional 1,800,000 shares. The company's common stock is traded on the Nasdaq under the ticker symbol MLYS. The offering was managed by leading financial institutions, ensuring a robust market entry for Mineralys, focusing on treating diseases linked to elevated aldosterone levels.
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