Mineralys Therapeutics (NASDAQ:MLYS) said it is continuing commercial-launch preparations for lorundrostat ahead of its December 22 Prescription Drug User Fee Act target date, while reporting a wider second-quarter loss driven largely by a $200 million upfront payment related to its amended agreement with Tanabe Pharma Corp.
Chief Executive Officer Jon Congleton said the company’s priorities during the second quarter included launch readiness, evaluating partnership opportunities and determining additional clinical-development plans for lorundrostat, an aldosterone synthase inhibitor being reviewed by the FDA for uncontrolled hypertension.
Clinical data and regulatory preparations
Mineralys highlighted analyses of its lorundrostat studies presented during the quarter. At the European Society of Hypertension meeting in May, the company presented a post hoc analysis of patients with chronic kidney disease from its pivotal Launch-HTN trial.
According to Congleton, those participants entered the study with more severe hypertension and more background antihypertensive treatments than the broader study population, but achieved statistically and clinically meaningful blood-pressure reductions comparable with the overall trial results. Patients with baseline albuminuria showed a 52% placebo-adjusted reduction in urine albumin-to-creatinine ratio, a marker of kidney injury and disease progression.
At the Endocrine Society’s ENDO 2026 meeting, Mineralys presented exploratory proteomic findings from the Launch-HTN and Advance-HTN trials. The company said lorundrostat was associated with reductions in multiple biomarkers related to heart-failure risk, though Congleton noted the findings were exploratory.
During the question-and-answer session, Congleton said discussions with the FDA to date had been “regular course” and that formal label and post-approval commitment discussions are generally expected to occur closer to the PDUFA date, likely in October or November. He said the company expects an indication for inadequately controlled blood pressure on top of background medications to be broadly similar to the indication anticipated for baxdrostat, while it intends to discuss inclusion of data from its Launch-HTN, Advance-HTN and Explore-CKD programs.
Congleton said Advance-HTN could provide a differentiating data set because the study confirmed uncontrolled or resistant hypertension after participants were moved to an American Heart Association-approved background regimen and were randomized only if blood pressure remained uncontrolled. He also said Explore-CKD data could inform physicians treating patients with lower estimated glomerular filtration rates.
Commercial buildout and payer outreach
Chief Commercial Officer Eric Warren said approximately 20 million U.S. adults have uncontrolled or resistant hypertension despite available treatments. Mineralys has been building a commercial organization designed to target physicians treating patients in later lines of therapy.
The company said it has established relationships with hypertension specialists and key opinion leaders, engaged with payers representing the vast majority of covered U.S. lives, developed launch messaging for providers and patients, and completed geographic mapping for field deployment.
Warren said the sales organization is expected to be staffed before the December PDUFA date. Congleton declined to disclose a specific number of representatives but said the company is focused on roughly 50,000 physicians who account for substantial volumes of third-line and later prescribing.
Management said early discussions with payers have supported its view that aldosterone synthase inhibitors could receive access in third- and fourth-line treatment settings. Warren said Mineralys expects coverage to build progressively through 2027, with commercial coverage developing ahead of Medicare coverage. He noted that Medicare access has so far relied on medical exceptions, which he described as having a favorable approval rate.
The company also plans to establish a field reimbursement manager team to support prior authorizations and patient support programs. On pricing, Congleton said Mineralys continues its analysis and does not expect to disclose lorundrostat’s price until approval or near launch. Management characterized baxdrostat’s pricing as consistent with its expectations and said it did not view that product’s pricing as specialty-tier pricing.
Royalty repurchase and financing
Mineralys agreed during the quarter to repurchase potential future royalty payments owed to Tanabe related to lorundrostat. The company will pay Tanabe $200 million upfront and could pay up to $100 million upon achieving certain commercial milestones. Aggregate potential future milestone payments to Tanabe are now up to $265 million.
Congleton said the transaction was a strategic opportunity to increase Mineralys’ long-term interest in lorundrostat as the company approaches possible commercialization.
Concurrent with the royalty arrangement, Mineralys completed a $150 million equity offering and entered a $500 million committed senior secured term-loan facility with funds managed by Pharmakon Advisors. The company said the financing adds flexibility beyond funding the royalty repurchase.
Second-quarter financial results
Mineralys ended the second quarter with $661.4 million in cash, cash equivalents and investments as of June 30, compared with $656.6 million at the end of 2025. Chief Financial Officer Adam Levy said the company believes its resources will fund planned operations, including a commercial launch of lorundrostat, into 2028.
- Research and development expense rose to $221.4 million from $38.3 million a year earlier, primarily reflecting the $200 million Tanabe upfront payment.
- General and administrative expense increased to $24.7 million from $8.5 million, driven principally by higher professional fees and personnel costs.
- Net loss widened to $241.1 million, compared with $43.3 million in the prior-year quarter.
Mineralys said it continues to consider broader development opportunities for lorundrostat in cardiorenal and metabolic conditions, while seeking a potential global partner that could support both commercialization outside the U.S. and future development efforts.
About Mineralys Therapeutics (NASDAQ:MLYS)
Mineralys Therapeutics, Inc, a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and chronic kidney diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone. The company was formerly known as Catalys SC1, Inc and changed its name to Mineralys Therapeutics, Inc in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania.
