Mineralys Therapeutics, Inc. Stock Price, News & Analysis

Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company specializing in treatments for hypertension and chronic kidney disease, has announced its participation in three upcoming investor conferences. The company will engage in fireside chats at the Guggenheim Healthcare Innovation Conference (November 12, 4:00pm EST), Stifel Healthcare Conference (November 19, 10:20am EST), and Evercore ISI HealthCONx Conference (December 4, 4:15pm EST). Live webcasts will be available on the company's website under the Investor Relations section, with replays accessible for approximately 90 days.

Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines for hypertension, chronic kidney disease and aldosterone-related disorders, has scheduled its Q3 2024 financial results announcement for November 11, 2024, after market close. The company will host a conference call at 4:30 p.m. ET on the same day, accessible via domestic (1-877-407-9127) and international (1-201-689-8574) dial-in numbers. A live webcast will be available through the company's Investor Relations website.

Mineralys Therapeutics (NASDAQ: MLYS) has completed enrollment ahead of schedule for Launch-HTN, the second pivotal trial evaluating lorundrostat for uncontrolled and resistant hypertension treatment. The trial's topline data is now expected in mid-first half of 2025, earlier than initially planned.

Launch-HTN is a global, randomized, double-blinded, placebo-controlled Phase 3 trial enrolling adults who failed to achieve blood pressure goals despite taking 2-5 antihypertensive medications. Participants were randomized into three groups: placebo, lorundrostat 50mg daily, and lorundrostat 50mg daily with potential titration to 100mg at week six.

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.