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On Monday, Stifel analysts reiterated their Buy rating for Mineralys Therapeutics , Inc. (NASDAQ:MLYS), currently trading at $17.67 with a market capitalization of $524 million, maintaining their price target of $45.00. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $24 to $45, suggesting significant upside potential. The affirmation follows the company’s announcement of positive outcomes from three clinical studies—TARGET-HTN, ADVANCE-HTN, and LAUNCH-HTN—that demonstrated high efficacy in treating uncontrolled and resistant hypertension (u/rHTN).
The LAUNCH study, which delivered results earlier than anticipated, was particularly notable for achieving significant reductions in systolic blood pressure (SBP) in a population that typically sees only marginal benefits from additional treatments. The positive news has contributed to MLYS’s strong performance, with InvestingPro data showing a 17.67% return over the past week, pushing the stock near its 52-week high. In this study, patients experienced an average drop of -16.9 mmHg at 6 weeks and -19.0 mmHg at 12 weeks. These results, when adjusted for placebo, indicated a lowering of -9.1 mmHg at 6 weeks and -11.7 mmHg at 12 weeks, which the analysts described as "clinically meaningful" and potentially "disruptive."
The ADVANCE-HTN study, although details remain under embargo until its presentation at the American College of Cardiology ( ACC (NSE:ACC)) 2025, is expected to have "guideline AND practice-altering potential," according to the analysts. These studies suggest that lorundrostat, the treatment developed by Mineralys Therapeutics, could gain universal access for fourth-line therapy and possibly for earlier stages of treatment, pending further analysis.
Stifel’s continued confidence in Mineralys Therapeutics is bolstered by the consistency of the drug’s performance across different patient populations. The ADVANCE-HTN study’s rigorous design led to a -7.9 mmHg SBP reduction, further reinforcing the potential of lorundrostat in the hypertension treatment landscape.
The analysts’ comments highlight the significance of these clinical trial results for Mineralys Therapeutics, as they demonstrate the potential to alter current treatment guidelines and practices for hypertension, a condition that affects a significant portion of the global population. While the company maintains a strong balance sheet with more cash than debt and a healthy current ratio of 14.02, InvestingPro subscribers have access to 8 additional key tips and a comprehensive Pro Research Report that provides deeper insights into the company’s financial health and growth potential.
In other recent news, Mineralys Therapeutics announced significant developments in its clinical trials and financial performance. The company reported positive topline results from its Launch-HTN and Advance-HTN trials for lorundrostat, a treatment for uncontrolled and resistant hypertension. Both trials met their primary endpoints, showing substantial reductions in systolic blood pressure with a favorable safety profile. However, Mineralys Therapeutics faced a financial setback, missing its earnings per share forecast for the fourth quarter of 2024, reporting an EPS of -0.98 against a projected -0.71. Despite this, the company maintains a robust cash position with $198.2 million in cash and investments, expected to fund operations through the first quarter of 2026.
Stifel analysts maintained a Buy rating and a $45 price target on Mineralys Therapeutics, expressing optimism about the company’s upcoming clinical study results. The analysts noted the importance of the pivotal study results from the ADVANCE-HTN and LAUNCH-HTN trials expected in 2025. Mineralys’ CEO Jon Congleton expressed confidence in the drug’s potential, indicating ongoing plans to present full results at the American College of Cardiology Scientific Sessions. The company is also advancing additional trials, such as the EXPLORE-CKD, targeting chronic kidney disease patients with hypertension. These recent developments reflect a mixed outlook for Mineralys Therapeutics, with promising clinical progress but notable financial challenges.
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