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) presented late-breaking data at ENDO 2026 on lorundrostat’s effects on heart failure (HF) risk biomarkers in uncontrolled hypertension. A post hoc proteomic analysis of 1,004 participants from the Launch-HTN and Advance-HTN trials showed significant changes in RAAS-related and HF risk biomarkers.
Lorundrostat was associated with increased renin, decreased angiotensinogen, and reductions in 6 of 11 candidate causal HF biomarkers, including NT-proBNP. Coordinated shifts in fibrosis, hemostasis and protease inhibitor markers support further evaluation of lorundrostat’s therapeutic potential in HF. Lorundrostat is under FDA review with a PDUFA target date of December 22, 2026.
Mineralys Therapeutics (NASDAQ: MLYS) announced participation in the Goldman Sachs 47th Annual Global Healthcare Conference in Miami, held June 8-10, 2026.
Management will join a fireside chat on Tuesday, June 9, 2026, at 2:40 p.m. ET, with a live webcast available via the company’s investor relations website.
Mineralys Therapeutics (Nasdaq: MLYS) will present late-breaking data on lorundrostat at ENDO 2026. The poster covers a post hoc proteomic analysis of heart failure risk biomarkers in participants with uncontrolled hypertension from the Launch-HTN and Advance-HTN trials, on June 14, 2026, in Chicago.
Mineralys Therapeutics (Nasdaq: MLYS) priced an underwritten public offering of 5,660,378 shares of common stock at $26.50 per share, for expected gross proceeds of about $150 million before expenses.
Net proceeds will help fund a $200 million upfront payment to repurchase a royalty obligation under a Tanabe Pharma license. The offering should close on or about June 4, 2026, subject to customary conditions. Earlier the company entered into a $500 million committed debt facility with funds managed by Pharmakon Advisors.
Mineralys Therapeutics (NASDAQ: MLYS) will repurchase all future lorundrostat royalties owed to Tanabe for $200 million upfront plus up to $100 million in commercial milestone payments. Aggregate remaining milestone obligations total up to $265 million. Tanabe will also assign lorundrostat IP rights to Mineralys.
The company entered a $500 million senior secured term loan with Pharmakon, with $100 million funded at closing, maturing in June 2031 at SOFR (3.25% floor) + 5.50%. Mineralys also priced an underwritten $150 million common stock offering.
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).