Mineralys reports new Launch-HTN data as lorundrostat PDUFA date nears December 22
Mineralys says commercialization plans remain on track ahead of its FDA decision date, with new blood pressure data and a terminated Tanabe license already behind it.
Mineralys Therapeutics reported third-quarter 2026 results on November 4, 2026, saying commercialization plans for lorundrostat are on track ahead of a PDUFA target date of December 22, 20261. The FDA's review of the lorundrostat NDA for hypertension in combination with other antihypertensive drugs continues toward that date, the company said.
The company highlighted a new analysis from the pivotal Phase 3 "Launch-HTN" trial showing that at Week 12, 46% of lorundrostat-treated participants on the 50 mg dose achieved the AHA/ACC guideline-recommended office systolic blood pressure target of under 130 mmHg, with more than two-thirds achieving a systolic reduction of at least 10 mmHg1, in participants who had uncontrolled or treatment-resistant hypertension despite taking two to five antihypertensive therapies1. A separate analysis found similar blood pressure reductions in participants with and without chronic kidney disease, with consistent results across Stages 1-3 CKD, and a 52% reduction in albuminuria versus placebo1.
In the Phase 2 "Explore-OSA" trial, final results showed lorundrostat 50 mg once daily in the evening reduced morning systolic blood pressure by 11.1 mmHg at Week 4 versus a 1.0 mmHg reduction with placebo, with no measurable change in apnea-hypopnea index and no serious safety events including hyperkalemia1. New long-term data from the Transform-HTN open-label extension trial is set for a late-breaking presentation at the American Heart Association Scientific Sessions 2026, taking place November 6-9 in Chicago1.
On commercial readiness, Mineralys said it now has an expanded medical affairs team and sales force in place, continues to engage with hypertension experts and payers, and is finalizing a patient support program1.
Financially, cash, cash equivalents and investments totaled $624.7 million as of September 30, 2026, down from $656.6 million at the end of 20251, which the company said it believes will be sufficient to fund planned operations, including the commercial launch of lorundrostat, into 20281. Net loss was $57.3 million for the quarter, compared with $36.9 million in the same period of 20251.
Separately, on October 27, 2026, Mineralys and Tanabe Pharma Corporation signed a Termination Agreement ending their 2020 license agreement for lorundrostat, with Tanabe assigning related patents and know-how to Mineralys. Under a companion Payment Obligation Agreement, Mineralys remains obligated to pay Tanabe the same milestone payments despite the license termination, and Tanabe's right of first negotiation for lorundrostat survives with respect to Japan2. Mineralys said it did not incur any material early termination penalties in connection with the termination.2
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