Mineralys Therapeutics outlined its commercial launch strategy for lorundrostat, an aldosterone synthase inhibitor under FDA review for uncontrolled hypertension, ahead of the agency’s December 22 Prescription Drug User Fee Act target date. The company reported that clinical analyses demonstrated meaningful blood-pressure reductions in patients with chronic kidney disease and a 52% placebo-adjusted reduction in albuminuria, a marker of kidney injury. Exploratory proteomic findings from two trials showed lorundrostat was associated with reductions in biomarkers related to heart-failure risk, though the company noted these results were preliminary.
Mineralys completed several significant financial transactions during the second quarter. The company paid Tanabe Pharma $200 million upfront to repurchase potential future royalty payments related to lorundrostat, with additional milestone payments of up to $100 million possible. The company simultaneously raised $150 million through an equity offering and secured a $500 million committed senior secured term-loan facility managed by Pharmakon Advisors. The company ended the quarter with $661.4 million in cash, cash equivalents and investments and indicated its resources would support operations into 2028.
On the commercial side, the company appointed Dr. Terry Ferguson as chief medical officer and stated that approximately 20 million U.S. adults have uncontrolled or resistant hypertension despite available treatments. Mineralys indicated it has been building a commercial organization targeting physicians in later lines of therapy, establishing relationships with specialists and key opinion leaders, and engaging with payers covering the vast majority of U.S. lives. Management said the sales organization is expected to be fully staffed before the December PDUFA date and will focus on approximately 50,000 physicians who account for substantial volumes of third-line and later prescribing.
The company’s second-quarter net loss widened to $241.1 million compared with $43.3 million in the prior-year quarter, primarily reflecting the $200 million Tanabe payment. Research and development expenses rose to $221.4 million from $38.3 million a year earlier, while general and administrative expenses increased to $24.7 million from $8.5 million. Management noted that early payer discussions supported potential access in third- and fourth-line treatment settings and that commercial coverage is expected to develop ahead of Medicare coverage.
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