Mineralys Therapeutics(US:MLYS) Globenewswire·2026-03-12 20:05Core Viewpoint - Mineralys Therapeutics has made significant progress in developing lorundrostat for hypertension, with the FDA accepting its New Drug Application (NDA) and setting a target date for potential approval on December 22, 2026 [1][9]. Financial Highlights - As of December 31, 2025, the company reported cash, cash equivalents, and investments totaling $656.6 million, a substantial increase from $198.2 million in 2024 [7][26]. - Research and Development (R&D) expenses for 2025 were $132.0 million, down from $168.6 million in 2024, with Q4 2025 R&D expenses at $24.4 million compared to $44.6 million in Q4 2024 [8][10]. - General and Administrative (G&A) expenses rose to $38.6 million for 2025, up from $23.8 million in 2024, with Q4 2025 G&A expenses at $13.9 million compared to $7.2 million in Q4 2024 [11]. - The net loss for 2025 was $154.7 million, an improvement from a net loss of $177.8 million in 2024, with Q4 2025 net loss at $32.2 million compared to $48.9 million in Q4 2024 [13][24]. Clinical and Regulatory Developments - The company completed multiple clinical trials for lorundrostat, with results published in reputable journals, demonstrating its potential to significantly reduce blood pressure in patients with inadequately controlled hypertension [3][5]. - The NDA submission for lorundrostat followed five positive clinical trials, showing clinically meaningful blood pressure reduction and a favorable safety profile [9][18]. - The ongoing Transform-HTN Open-Label Extension Trial aims to gather additional long-term safety and efficacy data for lorundrostat [6]. Market Context - Hypertension is a significant health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [15]. - Less than 50% of hypertension patients achieve their blood pressure goals with current medications, indicating a substantial unmet need in the market [16].