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.
Mineralys Therapeutics (Nasdaq: MLYS) appointed Jeffrey A. Munsie as Chief Legal Officer, effective March 24, 2026. Mr. Munsie has ~25 years of biopharma legal experience, including prior CLO roles at Orbital Therapeutics, Concert Pharmaceuticals, and Merrimack.
The Compensation Committee granted inducement awards on March 23, 2026: a 90,000-share stock option and 67,900 RSUs, vesting over four years with standard 25% first-year vesting, under the 2025 Employment Inducement Incentive Award Plan per Nasdaq Rule 5635(c)(4).
Mineralys Therapeutics (Nasdaq: MLYS) announced inducement equity awards granted March 16, 2026, to a new non-executive employee under its 2025 Employment Inducement Incentive Award Plan.
The Compensation Committee granted a stock option for 27,920 shares and restricted stock units for 20,940 shares. Options vest over four years (25% after one year, then 1/48th monthly); RSUs vest 25% on each anniversary through four years. Grants were made as an inducement in accordance with Nasdaq Listing Rule 5635(c)(4).
Mineralys Therapeutics (Nasdaq: MLYS) reported Q4 and full‑year 2025 results and key regulatory progress. The FDA accepted the NDA for lorundrostat with a PDUFA date of December 22, 2026. Cash and investments were $656.6 million at year‑end, supporting operations into 2028.
Clinical updates include five positive pivotal trials supporting the NDA and Explore‑OSA topline data showing significant blood pressure reduction but no meaningful AHI effect; open‑label extension continues.
Mineralys Therapeutics (NASDAQ: MLYS) announced FDA acceptance of the NDA for lorundrostat for treatment of adults with hypertension in combination with other antihypertensives, with a PDUFA target action date of December 22, 2026.
Topline Phase 2 Explore-OSA results: lorundrostat did not reduce AHI (primary endpoint) but produced clinically meaningful blood pressure reductions (11.1 mmHg vs baseline; 6.2 mmHg placebo-adjusted) after four weeks and showed a favorable safety profile with no serum potassium >5.5 mmol/L.
Mineralys Therapeutics (Nasdaq: MLYS) will report fourth quarter and full year 2025 financial results after market close on Thursday, March 12, 2026.
The company will host a conference call and live webcast at 4:30 p.m. ET on that date; dial-in numbers, conference ID 13758574, and a webcast link will be available on the Investor Relations News & Events page.
Mineralys Therapeutics (Nasdaq: MLYS) announced inducement equity awards granted February 23, 2026 to a new non-executive employee under its 2025 Employment Inducement Incentive Award Plan.
The Compensation Committee granted a stock option for 27,920 shares and 20,940 restricted stock units. Options vest over four years starting February 23, 2026; RSUs vest 25% annually on each anniversary. Awards were made as an inducement per Nasdaq Listing Rule 5635(c)(4).
Mineralys Therapeutics (Nasdaq: MLYS) announced inducement equity awards granted February 9, 2026 to two new non-executive employees under its 2025 Employment Inducement Incentive Award Plan. The Compensation Committee granted options for 33,504 shares and 25,128 restricted stock units.
Options vest over four years with 25% after one year (vesting commencement date February 9, 2026) and then 1/48th monthly thereafter; RSUs vest 25% on each of four anniversaries. Awards were made as inducements pursuant to Nasdaq Listing Rule 5635(c)(4).
Mineralys Therapeutics (Nasdaq: MLYS) issued a corporate update announcing clinical and regulatory milestones for lorundrostat, its investigational antihypertensive.
Key points: the company filed an NDA in late 2025 after completing three positive clinical trials in 2025; two global pivotal Phase 3 trials met primary endpoints; the Phase 2 Explore-CKD trial met its primary systolic blood pressure endpoint and reduced proteinuria; enrollment for Explore-OSA finished in Q3 2025 with topline results expected in Q1 2026. An open-label extension continues to collect long-term safety and efficacy data.
Mineralys Therapeutics (Nasdaq: MLYS) reported that its Phase 3 Launch-HTN trial of lorundrostat was selected in JAMA’s inaugural “Research of the Year Roundup” on Dec 12, 2025.
The 1,083-participant trial showed lorundrostat 50 mg once daily produced mean automated office systolic BP reductions of 16.9 mmHg at Week 6 (placebo-adjusted −9.1 mmHg, p<0.0001) and 19.0 mmHg at Week 12 (placebo-adjusted −11.7 mmHg, p<0.0001), with a diverse enrolled population and discontinuation rates <1%.
Safety signals included higher rates of hyponatremia, hyperkalemia, and reduced kidney function in the treatment arm. Ongoing trials include Transform-HTN and Explore-OSA with data expected Q1 2026.
Mineralys Therapeutics (Nasdaq: MLYS) announced on November 26, 2025 that its Compensation Committee granted an inducement stock option covering 146,000 shares to one new non-executive employee on November 24, 2025.
The award was made under the company’s 2025 Employment Inducement Incentive Award Plan and was granted as an inducement material to the employee entering employment in accordance with Nasdaq Listing Rule 5635(c)(4). The option vests over four years: 25% on the first anniversary of the vesting commencement date (November 24, 2026) and 1/48th monthly thereafter, subject to continued service.