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RADNOR, Pa. – Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company valued at approximately $1 billion and showing strong momentum with a 24% gain year-to-date, announced today that it will present data from its Phase 3 Launch-HTN trial at the upcoming 34th European Meeting on Hypertension and Cardiovascular Protection. The data concerns lorundrostat, the company’s investigational drug for the treatment of uncontrolled and resistant hypertension.
The late-breaking clinical trials session is scheduled for Saturday, May 24th, in Milan, where the efficacy and safety of lorundrostat will be the focus. The presenter, Dr. Manish Saxena, a hypertension specialist, will share findings from the study which aims to address conditions affected by dysregulated aldosterone, including hypertension and chronic kidney disease (CKD). According to InvestingPro data, five analysts have recently revised their earnings expectations upward for the upcoming period, suggesting growing confidence in the company’s prospects.
Lorundrostat is an orally administered aldosterone synthase inhibitor designed to reduce aldosterone levels by targeting the CYP11B2 enzyme. In its Phase 2 trial, the drug showed a significant reduction in blood pressure with a modest increase in serum potassium and other manageable side effects. These promising results have led to the Phase 3 trial, which could potentially support a New Drug Application (NDA) to the FDA. While the company maintains a strong liquidity position with its current ratio of 26.48, InvestingPro analysis indicates the company is quickly burning through cash, a common characteristic of clinical-stage biotech companies.
Mineralys Therapeutics has emphasized that the outcomes from the Launch-HTN study are critical to the drug’s future, as it may serve as one of the pivotal trials for FDA submission. However, the company also notes that the success of lorundrostat is contingent on various factors, including clinical trial results, regulatory developments, and manufacturing capabilities. With analyst price targets ranging from $26 to $48, significantly above current trading levels, investors seeking deeper insights can access comprehensive analysis and 10 additional ProTips through InvestingPro’s detailed research reports.
The information presented is based on a press release statement from Mineralys Therapeutics, Inc. and is intended to provide an update on the company’s progress in developing treatments for cardiorenal conditions.
In other recent news, Mineralys Therapeutics reported a better-than-expected earnings per share (EPS) for the first quarter of 2025, with a loss of $0.79 per share, surpassing the forecasted loss of $1.08. The company highlighted significant progress in its product pipeline, particularly with its hypertension treatment, Lorundrostat, which showed promising results in pivotal trials. Mineralys maintains a strong cash position, with cash, cash equivalents, and investments totaling $343 million, which the company believes will be sufficient to fund operations into 2027. Research and development expenses increased to $37.9 million from $30.8 million in the same quarter last year, reflecting the company’s continued investment in its product development efforts.
In addition to financial results, Mineralys is preparing for a potential FDA approval for Lorundrostat, with plans to submit a New Drug Application following the completion of studies and a pre-NDA meeting with the FDA in the fourth quarter of 2025. The company also announced the appointment of Eric Warren as Chief Commercial Officer, bringing extensive experience in the pharmaceutical industry. Analyst discussions during the earnings call indicated interest in the company’s trials related to chronic kidney disease and obstructive sleep apnea, highlighting the strategic focus on expanding treatment options. These developments underscore Mineralys’ commitment to advancing its pipeline and addressing unmet medical needs in the biotech sector.
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