RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) received U.S. Food and Drug Administration acceptance for its application seeking approval of lorundrostat for uncontrolled or resistant hypertension, moving the company closer to a potential commercial launch later this year.
The FDA assigned a Prescription Drug User Fee Act target date of December 22, 2026, for lorundrostat, which is being developed for use alongside existing antihypertensive therapies.
The application includes data from five clinical trials that Mineralys reported demonstrated blood pressure reduction, 24-hour control and a favorable safety profile in adults with uncontrolled or resistant hypertension.
Chief Executive Officer Jon Congleton described the FDA filing as a significant milestone as the company prepares for potential commercialization.
“We continue to make strong progress advancing lorundrostat toward potential approval,” Congleton said in a statement.
Mineralys is continuing market access planning, physician education efforts and sales preparation activities ahead of the FDA decision date.
The company’s ongoing Transform-HTN open-label extension study continues gathering additional long-term safety and efficacy data from patients receiving lorundrostat.
Cash, cash equivalents and investments totaled $646.1 million as of March 31, compared with $656.6 million at the end of 2025. Mineralys indicated existing capital is expected to fund operations, clinical development and regulatory activities into 2028.
First-quarter research and development expenses declined to $24.4 million from $37.9 million a year earlier, primarily reflecting lower clinical and preclinical spending after completion of the drug’s pivotal program in 2025.
General and administrative expenses increased to $21 million from $6.6 million, driven largely by higher professional fees and increased personnel costs tied to expanded operations and commercialization planning.
Net loss narrowed to $39.3 million in the quarter ended March 31, compared with $42.2 million during the same period last year.
The company also recorded $6 million in other income, up from $2.2 million a year earlier, reflecting higher interest income from investments in money market funds and U.S. Treasury securities.
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