Mineralys Therapeutics Shares Surge 203.4%, NDA Submission Expected in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 26 2025
0mins
Source: NASDAQ.COM
- Outstanding Stock Performance: Mineralys Therapeutics has seen its stock price soar by 203.4% in 2025, reflecting strong market confidence in its product candidate lorundrostat, which is expected to drive further growth in 2026.
- Successful Clinical Trials: In the first half of 2025, the pivotal Phase III Launch-HTN and Phase II Advance-HTN studies for lorundrostat met their primary efficacy endpoints, indicating its potential as a best-in-class treatment for resistant hypertension, which could significantly enhance the company's market position.
- NDA Submission Preparation: The company is gearing up to submit a New Drug Application (NDA) for lorundrostat in early 2026, paving the way for market entry and potentially boosting revenue and market share significantly.
- Multiple Research Advancements: Mineralys has also completed enrollment in the Phase II Explore-OSA study for lorundrostat in overweight and obese patients with moderate-to-severe OSA, with top-line data expected in Q1 2026, further strengthening its competitive edge in the market.
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Analyst Views on MLYS
Wall Street analysts forecast MLYS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MLYS is 52.60 USD with a low forecast of 46.00 USD and a high forecast of 56.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 32.090
Low
46.00
Averages
52.60
High
56.00
Current: 32.090
Low
46.00
Averages
52.60
High
56.00
About MLYS
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Lorundrostat is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. It has completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). It is also investigating the benefits of lorundrostat in subjects with hypertension and CKD and in subjects with hypertension and OSA.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Mineralys Highlights Lorundrostat Clinical Progress, Anticipates 2026 Data Release
- Clinical Trial Progress: Mineralys Therapeutics completed enrollment for the Phase 2 Explore-OSA trial in Q3 2025, with topline results expected in Q1 2026, aimed at evaluating lorundrostat's efficacy in hypertensive patients with obstructive sleep apnea, potentially reinforcing its market position in hypertension treatment.
- New Drug Application Submission: The company submitted an NDA for lorundrostat to the FDA in late 2025, following three positive clinical trials demonstrating best-in-class safety and 24-hour blood pressure control across diverse patient populations, which is expected to enhance its recognition in the hypertension treatment market.
- Long-term Safety Study: The ongoing Transform-HTN open-label extension trial allows participants to continue receiving lorundrostat, aimed at gathering additional long-term safety and efficacy data to support future market launch efforts.
- Positive CKD Trial Results: The Explore-CKD Phase 2 trial showed that lorundrostat met its primary endpoint by significantly reducing systolic blood pressure and proteinuria in patients with hypertension, reduced kidney function, and albuminuria, further validating its potential in treating related diseases.
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