Mineralys Therapeutics Surges 5.07% as Phase 3 Trial Data and Upcoming NDA Fuel Investor Optimism

Mineralys Therapeutics (NASDAQ: MLYS) surged 5.07% on Thursday, marking its eighth consecutive day of gains and a cumulative rise of 136.09% over the past eight sessions. The stock reached its highest intraday level since September 2025, with a 5.95% climb amid heightened investor optimism tied to recent clinical and regulatory developments.

The company’s Phase 3 Launch-HTN trial for lorundrostat, an aldosterone synthase inhibitor for uncontrolled hypertension, has driven market enthusiasm. The study demonstrated statistically significant blood pressure reductions across high-risk subgroups, including Black/African American patients, older adults, and those on multiple antihypertensive medications. These results, presented at the American Heart Association Hypertension Scientific Sessions, highlight the drug’s potential to address unmet needs in resistant hypertension, a condition affecting 10–15% of hypertensive patients.

Regulatory progress further bolstered investor confidence. Mineralys plans to submit a New Drug Application (NDA) for lorundrostat in late 2025 or early 2026, following a scheduled pre-NDA meeting with the FDA. The trial’s design, reflecting real-world clinical practices, is seen as advantageous for regulatory and payer acceptance. Analysts note that successful approval could position the drug as a first-in-class therapy in a high-growth market, where current treatments fail to meet patient needs.

Expert validation of the trial’s findings has also contributed to the stock’s momentum. Hypertension specialists, including Dr. Manish Saxena, have emphasized the drug’s potential to reduce cardiovascular mortality and healthcare costs in difficult-to-treat populations. Such endorsements are critical for physician adoption and reimbursement decisions, reinforcing the therapy’s commercial viability.

While risks remain—such as FDA approval uncertainties and competition from established antihypertensives—the company’s robust financial position and strategic focus on a niche market with strong unmet needs provide a foundation for long-term growth. Investors are closely monitoring the NDA process and broader macroeconomic factors, but the recent trial data and regulatory timeline have already catalyzed a sharp revaluation of Mineralys’ prospects.