RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported its fourth-quarter and full-year 2025 financial results and said the U.S. Food and Drug Administration has accepted its new drug application for lorundrostat, a treatment for hypertension.
The FDA assigned a Prescription Drug User Fee Act target date of December 22, 2026, for the agency’s decision on the drug.
The application seeks approval for lorundrostat to treat hypertension in adults when used with other blood pressure medications.
Chief Executive Officer Jon Congleton said the company made regulatory and clinical progress during 2025.
“We successfully completed multiple clinical trials, with results published in JAMA and The New England Journal of Medicine, highlighting the potential of lorundrostat to benefit patients with inadequately controlled hypertension,” Congleton said.
He added that the company “ended the year with the submission of our first NDA for the treatment of hypertension in adults.”
Mineralys said the regulatory filing followed a clinical program that included five trials showing reductions in blood pressure and a favorable safety profile in adults with uncontrolled or resistant hypertension.
The company also reported results from the Explore-OSA Phase 2 trial evaluating lorundrostat in patients with obstructive sleep apnea.
The study did not show a meaningful difference compared with placebo on the primary endpoint measuring apnea-hypopnea index.
However, the trial showed reductions in blood pressure after four weeks of treatment, including an 11.1 mmHg decrease among patients receiving lorundrostat compared with 1.0 mmHg in the placebo group.
Mineralys said lorundrostat was generally well tolerated during the study.
The company continues to collect long-term safety and efficacy data through the Transform-HTN open-label extension trial, which allows participants to continue receiving the treatment.
Mineralys reported cash, cash equivalents, and investments of $656.6 million as of December 31, 2025, compared with $198.2 million a year earlier.
The company said it expects its current cash position to fund clinical trials, regulatory activities, and operations into 2028.
Research and development expenses totaled $132.0 million for 2025, down from $168.6 million in 2024, primarily due to reduced clinical costs after completion of the lorundrostat pivotal program.
General and administrative expenses rose to $38.6 million from $23.8 million the previous year.
Mineralys reported a net loss of $154.7 million for 2025, compared with a net loss of $177.8 million in 2024.
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