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) will host a virtual KOL event on October 30, 2024, at 10:00 AM ET to discuss the unmet medical need in uncontrolled and resistant hypertension and the potential of lorundrostat as a treatment. The event will feature experts including Luke J. Laffin, MD (Cleveland Clinic), James M. Luther, MD, MSCI (Vanderbilt University Medical Center), and Rhian Touyz, MBBCh, MSc (Med), PhD (McGill University Health Centre). Topics will include the ongoing Advance-HTN and Launch-HTN pivotal trials, as well as results from the Phase 2 Target-HTN proof-of-concept trial. A live Q&A session will follow.
Mineralys Therapeutics (Nasdaq: MLYS) has achieved the target enrollment of 261 subjects in its pivotal Advance-HTN trial, evaluating lorundrostat for uncontrolled or resistant hypertension. The trial tests lorundrostat as an add-on therapy to standardized background treatment of two or three antihypertensive medications. Topline data is expected in Q1 2025.
The Advance-HTN trial is a randomized, double-blind, placebo-controlled Phase 2 study. Subjects are treated for twelve weeks in three cohorts: lorundrostat 50 mg QD, lorundrostat 50 mg QD with option to titrate to 100 mg QD at week four, or placebo.
Mineralys will host a virtual KOL event for investors on October 30, 2024, discussing the unmet need in hypertension and reviewing the ongoing pivotal clinical program for lorundrostat.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company, has announced its participation in the Wells Fargo Healthcare Conference in Boston, MA from September 4-6, 2024. The company's management will engage in a fireside chat on Thursday, September 5, 2024, at 1:30pm EDT.
Mineralys focuses on developing medicines for hypertension, chronic kidney disease (CKD), and other aldosterone-related disorders. Investors and interested parties can access a live webcast of the fireside chat through the company's website under the 'News and Events' section of Investor Relations. A replay will be available for approximately 90 days after the event.
Mineralys Therapeutics (MLYS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Advance-HTN trial is ~90% enrolled, with topline data expected in Q1 2025
- Launch-HTN Phase 3 trial enrollment is ahead of schedule, with topline data anticipated in 2H 2025
- Explore-CKD Phase 2 trial enrollment is ramping up, with topline data expected in 1H 2025
Financial highlights:
- Cash, cash equivalents, and investments: $311.1 million as of June 30, 2024
- R&D expenses: $39.3 million for Q2 2024
- G&A expenses: $5.9 million for Q2 2024
- Net loss: $41.0 million for Q2 2024
The company believes its current financial position will fund planned clinical studies and operations into 2026.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focusing on developing medicines for hypertension, chronic kidney disease (CKD), and aldosterone-related disorders, has announced its plan to release second quarter 2024 financial results on Tuesday, August 13, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day to discuss the results. Interested parties can access the call via domestic (1-877-407-9127) or international (1-201-689-8574) phone numbers, or through a webcast link available on the company's Investor Relations webpage.
Mineralys Therapeutics (NASDAQ: MLYS) has appointed Dr. Alexander M. Gold to its Board of Directors, effective June 13, 2024. Dr. Gold, a cardiologist with over 20 years of experience, has a strong background in developing and commercializing new therapies. His previous roles include Chief Medical Officer at Sanifit-CSL and Senior Vice President at Portola Pharmaceuticals. Concurrently, Dr. Olivier Litzka has resigned from the Board to focus on his venture capital investments. Mineralys is currently advancing the late-stage clinical development of lorundrostat, aimed at treating hypertension and other cardiorenal metabolic disorders.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference in Miami, FL from June 10-13, 2024. The company's management will engage in a fireside chat on June 11, 2024, at 4:00 pm EDT. The discussion will be webcast live and accessible through the Investor Relations section on the Mineralys website, with a replay available for 90 days.
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, reported its first quarter 2024 financial results and provided a corporate update. The company is focused on developing medicines targeting hypertension, chronic kidney disease, and other diseases related to dysregulated aldosterone. Their ongoing clinical trials for lorundrostat are expected to deliver topline data in Q4 2024 and 2H 2025. Mineralys also highlighted its strengthened balance sheet after completing a private placement financing in Q1 2024, providing them with sufficient funds until 2026.
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, will participate in a fireside chat at the Bank of America Securities Health Care Conference. The company focuses on developing medicines for hypertension, chronic kidney disease, and diseases driven by dysregulated aldosterone. The event will take place in Las Vegas on May 14-16, 2024. Investors can access a live webcast and replay of the chat on the company's website.
Mineralys Therapeutics, Inc. (NASDAQ: MLYS) will announce its first quarter 2024 financial results on May 9, 2024. The company focuses on developing medicines for hypertension, chronic kidney disease, and other diseases related to dysregulated aldosterone. The conference call will be hosted at 8:30 a.m. ET, offering dial-in and webcast options for participants.
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