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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, dedicated to developing innovative medicines for managing hypertension, chronic kidney disease (CKD), and other conditions driven by abnormally elevated aldosterone levels. The company's flagship product, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor. This medication is designed to treat patients with uncontrolled hypertension—defined as those unable to achieve blood pressure below 130/80 mmHg even with two or more antihypertensive medications—and resistant hypertension, affecting those who cannot reach the target BP despite taking three or more medications, including a diuretic.
Mineralys Therapeutics aims to revolutionize hypertension management by moving away from the traditional trial-and-error approach and introducing a more personalized treatment strategy. The company’s recent accomplishments underscore this commitment: the publication of their proof-of-concept study, Target-HTN, in the Journal of the American Medical Association, and the initiation of the Phase 3 Launch-HTN and Phase 2 Explore-CKD trials.
The company recently revealed robust financial results for the third quarter of 2023, reporting cash, cash equivalents, and investments totaling $265.9 million as of September 30, 2023, ensuring sufficient funding for planned clinical studies and operations through mid-2025. Mineralys also saw significant increases in both R&D and G&A expenses, attributed to the ramp-up in clinical activities and the transition to operating as a public company.
Mineralys’ lorundrostat has shown promising results in early trials, demonstrating a substantial reduction in plasma aldosterone concentration and clinically meaningful reductions in blood pressure among participants. The company is actively enrolling subjects in pivotal trials and expects to commence the Launch-HTN trial by the end of 2023, targeting real-world applications and responder profiling through biomarker-driven approaches.
Moreover, Mineralys is also focused on chronic kidney disease, which affects over 10% of the global population. Lorundrostat’s potential to treat CKD by targeting aldosterone—an underlying driver in cardiorenal conditions—positions Mineralys at the forefront of tackling complex, interrelated health issues.
For more information, visit their official website at https://mineralystx.com and follow Mineralys on LinkedIn and Twitter.
Mineralys Therapeutics (NASDAQ: MLYS) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its clinical development programs. The company anticipates topline data from two pivotal trials: Advance-HTN in March 2025 and Launch-HTN in mid-first half of 2025, both evaluating lorundrostat for uncontrolled or resistant hypertension.
Financial highlights include cash position of $198.2 million as of December 31, 2024, expected to fund operations through Q1 2026. R&D expenses increased to $168.6 million for 2024, up from $70.4 million in 2023. The company reported a net loss of $177.8 million for 2024, compared to $71.9 million in 2023.
The company completed enrollment in the Explore-CKD Phase 2 trial with data expected in Q2 2025 and plans to initiate a Phase 2 trial for obstructive sleep apnea and hypertension in Q1 2025.
Mineralys Therapeutics (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other aldosterone-related diseases, has scheduled its fourth quarter and full year 2024 financial results announcement. The results will be released before market open on Wednesday, February 12, 2025.
The company will host a conference call at 8:30 a.m. ET on the same day, accessible via domestic (1-800-717-1738) and international (1-646-307-1865) dial-in numbers. A live webcast will be available through the Investor Relations section of the company's website.
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.
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