RADNOR, Pa. - Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company with a market capitalization of $646 million, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application. According to InvestingPro data, analysts maintain a strong buy consensus on the stock, with price targets ranging from $26 to $45. The approval paves the way for a Phase 2 clinical trial of lorundrostat, aimed at treating patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.
The trial, expected to commence in the first quarter of 2025, will explore the efficacy of lorundrostat in reducing both the severity of upper airway obstruction and nocturnal hypertension—a condition that affects millions of Americans. The study will recruit approximately 40 subjects across 40 sites, focusing on those who are at least 18 years old with a body mass index (BMI) of 27 kg/m2 or higher.
Jon Congleton, CEO of Mineralys Therapeutics, expressed optimism about the potential of lorundrostat to address the cardiovascular risks associated with OSA, which include daytime hypertension. He highlighted that the drug could also alleviate symptoms like daytime sleepiness and cognitive impairment.
Dr. Reena Mehra, a sleep disorders researcher and new member of the Mineralys Scientific Advisory Board, underscored the importance of the trial. She emphasized the collaborative effort in designing the study to generate high-quality data that reflect the real-world challenges faced by OSA patients.
The upcoming trial will be a placebo-controlled, crossover study, with the primary outcome being the absolute change in the frequency of apnea-hypopnea episodes. Continuous blood pressure monitoring and patient-reported outcomes specific to OSA will also be assessed as part of the trial.
Lorundrostat, Mineralys' lead product candidate, is an aldosterone synthase inhibitor. It has shown promise in reducing aldosterone levels, which play a role in hypertension and other cardiorenal conditions. Previous Phase 2 trials have demonstrated the drug's potential in lowering blood pressure with a favorable safety profile.
The company believes its current financial resources will support its operations and clinical trial activities through the first quarter of 2026. InvestingPro analysis shows Mineralys holds more cash than debt on its balance sheet, though it's currently burning through cash at a notable rate. The company maintains a healthy current ratio of 8.55, indicating strong short-term liquidity. This announcement is based on a press release statement from Mineralys Therapeutics.For deeper insights into Mineralys' financial health and growth prospects, including 8 additional key ProTips and comprehensive valuation metrics, visit InvestingPro, where you'll find detailed analysis in our Pro Research Report.
In other recent news, Mineralys Therapeutics disclosed its Q3 2024 results and progress on its clinical trials during an earnings call. The company reported an increase in cash and investments to $263.6 million and a rise in R&D expenses, resulting in a net loss of $56.3 million for the quarter. The Advance-HTN and Launch-HTN trials for their leading drug candidate, lorundrostat, have completed enrollment, with results expected in March and mid-2025, respectively. These developments are part of recent events at Mineralys. The company's financial resources are projected to fund operations into 2026. During the Q&A session, questions focused on clinical trial data, safety findings, and adherence rates. Mineralys is optimistic about upcoming data milestones for lorundrostat expected in the first half of 2025. However, the net loss for the quarter increased significantly compared to the previous year, primarily due to higher R&D expenses. Despite this, the company maintains a robust cash position to support its research and development activities.
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