Mineralys Therapeutics (NASDAQ:MLYS) is preparing to launch its hypertension drug candidate lorundrostat if it wins regulatory approval, with a U.S. Food and Drug Administration decision targeted for Dec. 22, executives said on the company’s third-quarter earnings call.
CEO Jon Congleton said discussions with the FDA were proceeding in the normal course. The company has not provided a specific launch timetable, but aims to reach patients as soon as possible after a potential approval.
Mineralys reported a wider third-quarter net loss as it increased spending ahead of commercialization. It also highlighted new clinical analyses and said additional long-term data are scheduled for presentation on Nov. 8.
Launch preparations and payer access
Chief Commercial Officer Eric Warren said the company’s field sales team is in place, with representatives averaging approximately 15 years of industry experience. Mineralys has also expanded its medical affairs capabilities and engaged payers representing a majority of covered lives in the United States, he said.
Warren expects commercial insurance to provide initial coverage, while some Medicare patients could obtain access through an exception process. He said the company’s planned patient support program is intended to help physicians, their staff and patients navigate access and should be available shortly after a launch.
Congleton said Mineralys would also miss the Medicare bid cycle if lorundrostat is approved, but he expects patients to be able to seek access before the drug is added to formularies. Warren said he expects Medicare and commercial coverage to contribute roughly equally once access reaches a steady state, without specifying when that would occur.
Executives declined to provide lorundrostat’s price, expected gross-to-net discounts or a timeline for broad coverage. Congleton said the company would communicate its pricing and access plans after approval and launch, and that it was premature to specify which launch metrics it would report.
Asked about AstraZeneca’s competing drug Baxfendy, Congleton said its early launch supported Mineralys’ view that demand and access exist for aldosterone synthase inhibitors. Warren called initial prescription trends encouraging, while noting that limited visibility into rebates and other discounts made it difficult to assess the competitor’s net pricing.
Clinical updates
Mineralys estimates that approximately 20 million U.S. adults treated with at least two blood pressure drugs remain above their treatment goals. In a new 12-week analysis of the Phase 3 LAUNCH-HTN trial, 46% of participants receiving 50 milligrams of lorundrostat reached the guideline-recommended office systolic blood pressure target of less than 130 mm Hg, Congleton said. More than two-thirds achieved a reduction of at least 10 mm Hg.
The trial enrolled people with uncontrolled or treatment-resistant hypertension who were already taking two to five antihypertensive therapies. Congleton said the findings support lorundrostat’s potential in patients who have struggled to reach their goals with existing treatments.
In the Phase 2 EXPLORE-OSA trial, which studied overweight or obese adults with moderate to severe obstructive sleep apnea and hypertension, the company said a once-daily 50-milligram dose reduced morning systolic blood pressure by 11.1 mm Hg at week four, compared with a 1.0 mm Hg reduction for placebo. The study did not show a measurable change in the apnea-hypopnea index, a measure of sleep apnea severity. Congleton said there was no evidence of serious safety events, including hyperkalemia, in the study.
New long-term efficacy and safety data from the ongoing TRANSFORM-HTN open-label extension trial are scheduled for a late-breaking presentation at the American Heart Association Scientific Sessions on Nov. 8 in Chicago.
Mineralys is evaluating further development of lorundrostat in aldosterone-driven conditions beyond hypertension, but Congleton did not identify a priority indication or announce a new trial. He also said the company routinely evaluates potential partnerships but could not discuss specific activities.
Loss widens as launch spending rises
Mineralys reported a third-quarter net loss of $57.3 million, compared with $36.9 million a year earlier. General and administrative expenses rose to $37.4 million from $9.7 million, primarily reflecting professional fees and personnel costs associated with preparations for commercialization.
Research and development expenses fell to $22.7 million from $31.5 million, mainly because of lower preclinical and clinical costs following the conclusion of the lorundrostat pivotal program in the second quarter of 2025.
Chief Financial Officer Adam Levy said cash equivalents and investments totaled $624.7 million at Sept. 30, compared with $656.6 million at the end of 2025. The company expects those resources to fund planned operations, including a potential commercial launch, into 2028.
Mineralys also announced that Chris Peterson and Lonnel Coats had joined its board. Director Derek DiRocco is expected to conclude his tenure at year-end, Congleton said.
About Mineralys Therapeutics (NASDAQ:MLYS)
Mineralys Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing therapies for cardiovascular and kidney diseases associated with excess aldosterone activity. The company’s research centers on selectively targeting aldosterone production, a mechanism involved in blood-pressure regulation and organ damage.
Mineralys’ lead product candidate is lorundrostat, an oral, selective aldosterone synthase inhibitor being evaluated as a potential treatment for uncontrolled and resistant hypertension.
