Mineralys Therapeutics, INC 8-K filings

Mineralys Therapeutics reported Q2 2026 financial results, highlighted by ongoing FDA review of lorundrostat with a PDUFA date of December 22, 2026, and a strengthened balance sheet.

Mineralys Therapeutics announced the pricing of a $150 million underwritten offering of its common stock at $26.50 per share.

Mineralys Therapeutics has amended its license agreement for lorundrostat, eliminating future royalty payments and securing a $500 million senior secured term loan facility.

Mineralys Therapeutics stockholders re-elected three Class III directors and ratified the appointment of Ernst & Young LLP as the company's independent auditor.

Mineralys Therapeutics announced first quarter 2026 financial results, highlighting the FDA's acceptance of its New Drug Application for lorundrostat with a PDUFA target date of December 22, 2026.

Mineralys Therapeutics announced FDA acceptance of its New Drug Application for lorundrostat for hypertension, setting a PDUFA target date of December 22, 2026, alongside its Q4 and full-year 2025 financial results.

Mineralys Therapeutics announced the submission of a New Drug Application for lorundrostat to the FDA and confirmed it is on track to report Phase 2 Explore-OSA trial results in Q1 2026.

Mineralys Therapeutics reports Q3 2025 financial results, highlights progress towards lorundrostat NDA submission, and announces completion of Explore-OSA trial enrollment.

Mineralys Therapeutics announced the pricing of an upsized $250.0 million underwritten public offering of common stock to fund clinical development and general corporate purposes.

Mineralys Therapeutics, Inc. announced the suspension and termination of its current prospectus supplement for its At-The-Market (ATM) equity offering, though the underlying sales agreement remains active.

Mineralys Therapeutics announced positive clinical trial results for lorundrostat in hypertension and CKD, alongside a robust cash position extending into 2027, as it prepares for an FDA pre-NDA meeting.

Mineralys Therapeutics announced positive topline results from its Phase 2 Explore-CKD trial, demonstrating lorundrostat's efficacy in reducing blood pressure and albuminuria in patients with hypertension and comorbid chronic kidney disease, alongside a favorable safety profile.

Mineralys Therapeutics held its 2025 annual meeting of stockholders on May 22, 2025, where stockholders voted on and approved the election of two directors and the ratification of the company's independent auditor.

Mineralys Therapeutics reported positive topline results from pivotal hypertension trials and provided a corporate update, including financial results for the first quarter ended March 31, 2025.

Mineralys Therapeutics reports positive results from its Phase 2 Advance-HTN trial, demonstrating lorundrostat's efficacy in reducing blood pressure in patients with uncontrolled or resistant hypertension.

Mineralys Therapeutics has announced a $175 million underwritten public offering of its common stock to fund clinical development and other corporate purposes.

Mineralys Therapeutics reports positive topline data from its Launch-HTN Phase 3 and Advance-HTN Phase 2 trials, indicating lorundrostat's efficacy and safety in treating uncontrolled and resistant hypertension.

Mineralys Therapeutics announces its Q4 and full year 2024 financial results, highlighting clinical trial progress and upcoming milestones for lorundrostat.

Mineralys Therapeutics announces the completion of enrollment in its Explore-CKD Phase 2 trial evaluating lorundrostat for hypertension in chronic kidney disease patients.

Mineralys Therapeutics has received FDA clearance for a Phase 2 clinical trial of lorundrostat to treat obstructive sleep apnea in patients with hypertension.

Mineralys Therapeutics reports completed enrollment in two pivotal Phase 3 trials for lorundrostat and anticipates topline data in the first half of 2025, alongside third quarter financial results.

Mineralys Therapeutics announced the completion of enrollment in its Launch-HTN trial ahead of schedule, with topline data expected in the mid first half of 2025.

Mineralys Therapeutics has completed target enrollment in its pivotal Advance-HTN trial for lorundrostat, a potential treatment for hypertension.

Mineralys Therapeutics reported its second quarter 2024 financial results and provided an update on its clinical trial programs, including the progress of its lorundrostat trials.

Mineralys Therapeutics has appointed Alexander M. Gold to its Board of Directors and Nominating and Corporate Governance Committee, while Olivier Litzka has resigned from the Board, effective June 13, 2024.

Mineralys Therapeutics is modifying the primary endpoint of its Advance-HTN trial to align with FDA feedback, focusing on a shorter timeframe for blood pressure assessment.

Mineralys Therapeutics receives a legal opinion from Faegre Drinker Biddle & Reath LLP regarding the legality of shares to be issued under its $100 million ATM equity offering.

Mineralys Therapeutics successfully held its 2024 annual meeting, electing a director and ratifying its independent auditor.

Mineralys Therapeutics reported its Q1 2024 financial results and provided updates on its ongoing clinical trials for lorundrostat, a treatment for hypertension and chronic kidney disease.

Alexander Asam, Ph.D., a member of the Board of Directors at Mineralys Therapeutics, Inc., will not seek re-election at the company's 2024 annual meeting.