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. develops medicines for hypertension and related comorbidities driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for hypertension, chronic kidney disease, obstructive sleep apnea and other aldosterone-related conditions.
Mineralys news commonly covers lorundrostat clinical data, FDA regulatory updates, New Drug Application developments, and corporate updates tied to clinical and regulatory funding. Other recurring announcements include quarterly financial results, health care conference participation, executive appointments, and employee equity inducement awards under Nasdaq Listing Rule 5635(c)(4).
Mineralys Therapeutics (Nasdaq: MLYS) reported new Phase 3 Launch-HTN data on lorundrostat in participants with hypertension and chronic kidney disease (CKD). Once-daily 50 mg lorundrostat produced significant placebo-adjusted systolic blood pressure reductions at 12 weeks and a 52.2% urinary albumin-to-creatinine ratio decrease in CKD patients with baseline albuminuria, with a favorable safety profile. Lorundrostat is under FDA review with a PDUFA target date of December 22, 2026.
Mineralys Therapeutics (NASDAQ: MLYS) announced that its management will participate in the Jefferies 2026 Global Healthcare Conference in New York from June 2-4, 2026.
The company is scheduled for a corporate presentation on June 3, 2026 at 7:35 a.m. EDT, with a live webcast available via its Investor Relations “News & Events” page.
Mineralys Therapeutics (Nasdaq: MLYS) will present new Phase 3 Launch-HTN data on lorundrostat in patients with uncontrolled hypertension and chronic kidney disease at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland.
The oral presentation is scheduled for May 30, 2026.
Mineralys Therapeutics (Nasdaq: MLYS) announced FDA acceptance of the NDA for lorundrostat for adults with uncontrolled or resistant hypertension, with a PDUFA target date of December 22, 2026. The submission includes five positive clinical trials and an ongoing open-label extension. Cash, cash equivalents and investments were $646.1 million as of March 31, 2026; the company expects funding into 2028. Q1 R&D was $24.4 million and G&A was $21.0 million; net loss was $39.3 million for the quarter. A conference call was scheduled for May 6, 2026 at 4:30 p.m. ET.
Mineralys Therapeutics (Nasdaq: MLYS) announced on May 5, 2026 that its Compensation Committee granted inducement equity awards to two new non-executive employees.
The grants include 29,760 stock options and 22,320 restricted stock units under the 2025 Employment Inducement Incentive Award Plan, with vesting beginning May 4, 2026 and scheduled over four years. Awards were made pursuant to Nasdaq Listing Rule 5635(c)(4).
Mineralys Therapeutics (NASDAQ: MLYS) said management will participate in the Bank of America Securities 2026 Health Care Conference in Las Vegas on May 12, 2026 at 9:20am PT in a fireside chat.
A live webcast will be available via the company’s Investor Relations "News & Events" page.
Mineralys Therapeutics (Nasdaq: MLYS) will report first-quarter 2026 financial results for the period ended March 31, 2026, after market close on Wednesday, May 6, 2026. A conference call and live webcast will begin at 4:30 p.m. ET with domestic and international dial-in access and a webcast link on the investor site.
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.