Mineralys Therapeutics, Inc. - MLYS STOCK NEWS

Mineralys Therapeutics (NASDAQ: MLYS) has completed enrollment in its Explore-CKD Phase 2 trial, evaluating lorundrostat for treating hypertension in patients with Stage 2 to 3b CKD and albuminuria. The trial focuses on patients already receiving stable treatment with ACEi or ARB and SGLT2 inhibitors.

The study is designed as a randomized, double-blind, placebo-controlled, two-period, two-sequence crossover trial, testing 25 mg once-daily lorundrostat. The primary endpoint measures change in systolic blood pressure at week four compared to placebo, with an exploratory endpoint examining changes in urine albumin-to-creatinine ratio.

The company expects to announce topline data in Q2 2025. This marks Mineralys's third trial to complete enrollment, alongside Target-HTN, Advance-HTN, and the recently announced Explore-OSA trials.

Mineralys Therapeutics (NASDAQ: MLYS) has received FDA clearance for its IND Application to conduct a Phase 2 clinical trial evaluating lorundrostat in treating patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The trial is set to begin in Q1 2025.

The planned study will be placebo-controlled and crossover-designed, testing lorundrostat 50mg once daily in approximately 40 subjects across 40 sites. Participants must be at least 18 years old with a BMI ≥27 kg/m2. The trial aims to validate lorundrostat's ability to reduce upper airway obstruction and nocturnal hypertension, with the primary outcome measuring changes in apnea-hypopnea episodes.

OSA represents Mineralys' third targeted indication for lorundrostat, affecting an estimated 54 million people in the U.S., including 30-50% of adults with hypertension. The company confirms sufficient funding through Q1 2026 to support planned clinical trials and operations.

Mineralys Therapeutics (NASDAQ: MLYS) announced completion of enrollment in two pivotal trials for lorundrostat, targeting uncontrolled and resistant hypertension. The company expects topline data from Advance-HTN trial in March 2025 and Launch-HTN Phase 3 trial in mid-first half 2025. Enrollment continues in the Explore-CKD Phase 2 trial, with data expected in Q2 2025.

Financial highlights show cash position of $263.6 million as of September 30, 2024. R&D expenses increased to $54.0 million from $22.5 million year-over-year. Net loss widened to $56.3 million compared to $22.8 million in Q3 2023.

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.