Stock Analysis

Could Mineralys Therapeutics (MLYS) Trial Progress Hint at a Broader Hypertension Strategy?

  • Mineralys Therapeutics announced it has completed enrollment in its Phase 2 EXPLORE-OSA trial of lorundrostat in participants with moderate-to-severe obstructive sleep apnea and hypertension, with topline results expected in the first quarter of 2026.
  • This milestone highlights ongoing clinical progress to address an unmet need in hypertension treatment, potentially expanding lorundrostat's reach into additional patient populations with related comorbidities.
  • We’ll explore how this trial enrollment milestone signals continued progress in expanding lorundrostat's potential use for patients with complex hypertension profiles.

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What Is Mineralys Therapeutics' Investment Narrative?

If you’re looking at Mineralys Therapeutics right now, the core belief for investors centers on the potential for lorundrostat to address substantial unmet needs in hypertension, with compelling data from high-profile trials, growing clinical momentum and multiple potential indications as the big drivers. The recent completion of enrollment in the Phase 2 EXPLORE-OSA trial doesn’t immediately change near-term catalysts, as top-line data is still more than a year away. Momentum continues to come from the company’s upcoming pre-NDA meeting, planned New Drug Application filing and previous positive Phase 3 results, which remain the primary short-term inflection points. However, news of enrollment progress adds reassurance on execution, promises to widen lorundrostat’s footprint if positive and could meaningfully shift risk perception if the trial reads out successfully, especially when paired with results from the CKD trial. Still, the company remains unprofitable, has no meaningful revenue, and recent share offerings have caused dilution, so risks remain elevated for those focused on fundamentals and capital structure.

But keep in mind, heavy recent dilution is an important risk that shouldn’t be overlooked. Mineralys Therapeutics' shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

Exploring Other Perspectives

MLYS Earnings & Revenue Growth as at Oct 2025
MLYS Earnings & Revenue Growth as at Oct 2025
Only two fair value estimates from the Simply Wall St Community ranged widely from US$4.38 to US$43.75 per share. While the pipeline momentum excites many, the wide gulf between these viewpoints underscores ongoing uncertainty around future dilution and profitability. Consider exploring these diverse perspectives as part of your research.

Explore 2 other fair value estimates on Mineralys Therapeutics - why the stock might be worth as much as 8% more than the current price!

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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