Mineralys Therapeutics announced the repurchase of all future royalty payments to Tanabe Pharma for lorundrostat, paying $200 million upfront plus up to $100 million upon commercial milestones. Concurrently, the company secured a $500 million senior secured term loan facility from Pharmakon Advisors and priced a $150 million common stock offering to strengthen its balance sheet.

Velan Capital Investment Management LP sold 140,000 shares of Mineralys Therapeutics in Q1 2026, valued at approximately $4.11 million, reducing its stake to 11,000 shares. Despite the fund's reduction, Mineralys stock has surged 87.84% over the past year. The clinical-stage biotech company is awaiting FDA approval for its lead candidate lorundrostat by December 22, 2026, and maintains $646 million in cash.

Mineralys Therapeutics presented post hoc analysis data from its Phase 3 Launch-HTN trial showing that lorundrostat, an aldosterone synthase inhibitor, achieved statistically significant blood pressure reductions in patients with chronic kidney disease (CKD) and hypertension. The drug demonstrated a 9.6 mmHg placebo-adjusted systolic blood pressure reduction in CKD patients and a 52.2% reduction in urinary albumin-to-creatinine ratio in those with baseline albuminuria, with a favorable safety profile. The drug is currently under FDA review with a PDUFA target date of December 22, 2026.

Mineralys Therapeutics presented clinical data for lorundrostat at ASN Kidney Week 2025, demonstrating promising results in reducing blood pressure and albuminuria in chronic kidney disease patients. The company plans to file a New Drug Application with the FDA in late 2025 or early 2026.

Two healthcare stocks, Precigen and Mineralys Therapeutics, have seen significant stock price increases recently due to FDA approval and promising clinical trial results in rare disease treatment and hypertension medication development.

Mineralys Therapeutics presented subgroup analyses from its Phase 3 Launch-HTN trial, demonstrating lorundrostat's efficacy in reducing blood pressure across diverse high-risk patient populations with uncontrolled hypertension, with consistent safety and meaningful clinical results.

Mineralys Therapeutics has priced a public offering of 9,803,921 shares at $25.50 per share, expecting to raise approximately $250 million to fund clinical development and corporate activities.

Mineralys Therapeutics announced positive results from the Phase 3 Launch-HTN trial of its drug lorundrostat for the treatment of uncontrolled or resistant hypertension. The trial demonstrated clinically meaningful and sustained reductions in systolic blood pressure with a favorable safety profile.

Mineralys Therapeutics announced positive results from the Advance-HTN trial, which evaluated the efficacy and safety of their drug lorundrostat in patients with uncontrolled or resistant hypertension. The 50 mg dose of lorundrostat demonstrated a significant reduction in 24-hour ambulatory blood pressure, with a favorable safety profile.

Mineralys Therapeutics has completed enrollment for its pivotal Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension. The company expects to announce topline data in Q1 2025.

Mineralys Therapeutics, Inc. (MLYS) released its Q2 2024 financial results, which missed analyst consensus estimates, causing a sharp drop in the company's stock price. Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of Mineralys investors.

Dr. Olivier Litzka has resigned from the Board, effective June 13, 2024 Dr. Olivier Litzka has resigned from the Board, effective June 13, 2024