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RADNOR, Pa. - Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company with a market capitalization of $524 million, has reported positive topline results from its Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial for lorundrostat, a treatment for uncontrolled and resistant hypertension. The trials met primary endpoints, showing significant reductions in systolic blood pressure with a favorable safety profile. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 14.02, though it remains pre-revenue as it develops its pipeline.
The Launch-HTN trial, which enrolled adults on multiple antihypertensive medications, demonstrated a 16.9 mmHg absolute reduction and a 9.1 mmHg placebo-adjusted reduction in systolic blood pressure at week six. By week 12, the reduction improved to 19.0 mmHg absolute and 11.7 mmHg placebo-adjusted. The Advance-HTN trial showed a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12, assessed via 24-hour ambulatory blood pressure monitoring. The positive trial results have contributed to the stock’s recent momentum, with InvestingPro showing a 17.7% return over the past week, though the stock remains slightly undervalued based on Fair Value analysis.
Safety outcomes from both trials suggest a favorable risk-benefit profile for lorundrostat, with low incidences of serious adverse events and hyperkalemia. The results indicate that lorundrostat could be an effective treatment option for the estimated 15 to 20 million patients in the U.S. with uncontrolled hypertension.
Mineralys CEO Jon Congleton expressed confidence in lorundrostat’s potential, citing the completion of three clinical trials that support the drug’s efficacy and safety. The company plans to present full results from Advance-HTN on March 29, 2025, at the American College of Cardiology Scientific Sessions.
The news of these successful trials comes as hypertension remains a leading cause of cardiovascular deaths. Lorundrostat’s development focuses on addressing dysregulated aldosterone, a common factor in hypertension. With these positive findings, Mineralys aims to provide additional data at future medical conferences and in peer-reviewed publications.
This article is based on a press release statement from Mineralys Therapeutics, Inc.
In other recent news, Mineralys Therapeutics reported a significant miss in its earnings per share (EPS) for the fourth quarter of 2024, with an EPS of -0.98 compared to the forecasted -0.71. The company’s research and development expenses increased substantially, contributing to a net loss of $177.8 million for the year, up from $71.9 million in 2023. Despite the earnings miss, Mineralys maintains a strong cash position of $198.2 million, expected to support operations through the first quarter of 2026. The company continues to focus on its clinical trials for lorondristat, targeting hypertension and chronic kidney disease, with pivotal trial results anticipated in 2025.
Stifel analysts have maintained a Buy rating on Mineralys Therapeutics, with a $45 price target, expressing optimism about the company’s upcoming clinical study results. The firm emphasized the potential of lorondristat, particularly in reducing blood pressure in patients with uncontrolled hypertension. Analysts highlighted that the drug’s market potential will depend significantly on its performance in specific patient groups. These developments are crucial as they could determine the regulatory and commercial viability of lorondristat.
Mineralys is advancing pivotal trials, with the ADVANCE-HTN trial results expected in March 2025 and the LAUNCH-HTN trial anticipated in mid-2025. The company is also exploring additional indications for lorondristat, including obstructive sleep apnea, with top-line data from the CKD trial expected in the second quarter of 2025. These clinical trials and their outcomes are essential for the company’s future prospects and investor confidence.
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