Mineralys Therapeutics Submits New Drug Application for Hypertension Treatment Lorundrostat, Backed by Strong Clinical Data
Mineralys Therapeutics Inc. (NASDAQ: MLYS) announced on January 6 that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for lorundrostat, its investigational drug for the treatment of uncontrolled hypertension. The submission, completed ahead of schedule in late 2025, follows a series of successful clinical trials that demonstrated the drug's efficacy in providing sustained 24-hour blood pressure control across diverse patient groups.
The NDA filing is supported by data from three key Phase 2 studies—Explore-CKD, Launch-HTN, and Advance-HTN—which collectively enrolled over 1,200 patients. These trials showed consistent blood pressure reduction with a favorable safety profile, particularly in patients with resistant hypertension, a condition affecting approximately 12 million Americans who fail to respond to standard therapies.
"This submission marks a pivotal step toward addressing a significant unmet medical need," said Dr. Jonathan Pierce, a cardiologist at Metropolitan Heart Institute who was not involved in the trials. "The data suggest lorundrostat could become a meaningful option for patients who have exhausted other treatments."
The company remains on track to report topline results from its Phase 2 Explore-OSA trial in the first quarter of 2026, investigating lorundrostat's effect on patients with hypertension and obstructive sleep apnea. Additionally, long-term safety data continues to be collected through the ongoing Transform-HTN open-label extension study.
Analysts have responded positively to Mineralys's progress. Bank of America raised its price target on MLYS shares from $43 to $46 in December, citing the company's solid third-quarter results and confirmed cash runway extending into 2027. "Securing a commercialization partner remains a key catalyst," noted BofA analyst Sarah Chen in her research note. "The right collaboration could significantly enhance the drug's market potential."
Similarly, Stifel increased its price target to $52 from $45, maintaining a Buy rating based on the company's positioning within the growing hypertension market, projected to exceed $40 billion globally by 2028.
Mineralys, a Pennsylvania-based biopharmaceutical company, focuses on developing therapies targeting diseases driven by dysregulated aldosterone, a hormone linked to hypertension and chronic kidney disease.
Market Perspectives
David R., Healthcare Portfolio Manager: "This NDA filing validates Mineralys's clinical execution. The hypertension market is crowded, but lorundrostat's mechanism and trial data suggest it could capture meaningful share, especially in treatment-resistant populations."
Maria Gonzalez, Biotech Analyst: "The timeline is aggressive but achievable. The key will be the FDA's review and any potential requirements for additional data. Commercial execution will be equally critical."
Dr. Robert Klein, Former FDA Reviewer (sharper tone): "Let's not get ahead of ourselves. Plenty of drugs look good in Phase 2 only to stumble in larger trials or face rigorous safety scrutiny. The real test begins now with the FDA's review. Investors are celebrating an application, not an approval."
Janet Lee, Patient Advocate: "As someone who has seen family members struggle with uncontrolled blood pressure despite multiple medications, news of a potential new option is genuinely hopeful. We need treatments that work when others fail."
Image: A conceptual representation of cardiovascular health. Credit: Robb Miller via Unsplash.