Stock Analysis

Mineralys Therapeutics (MLYS) Is Up 10.8% After Completing Phase 2 OSA Trial Enrollment – What's Changed

  • Mineralys Therapeutics announced it has completed enrollment in its Phase 2 EXPLORE-OSA clinical trial studying lorundrostat in patients with moderate-to-severe obstructive sleep apnea and hypertension.
  • This milestone sets the stage for upcoming top-line trial results in early 2026, potentially expanding lorundrostat’s utility across challenging patient populations with interconnected conditions.
  • We'll explore how advancing lorundrostat toward pivotal data in OSA and hypertension could shape Mineralys’s broader investment thesis.

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What Is Mineralys Therapeutics' Investment Narrative?

For investors considering Mineralys Therapeutics, the central thesis revolves around belief in lorundrostat's potential to address overlapping populations with hypertension and related comorbidities. The just-completed enrollment for the EXPLORE-OSA trial marks a significant step, as it sets a clear timetable for new Phase 2 results, and complements recently reported positive data in related trials. In the near term, this milestone slightly shifts the focus toward upcoming data in early 2026 as a primary catalyst, especially with management pushing for a regulatory filing strategy. However, key risks remain, including continued operating losses, recent share price volatility, and the impact of shareholder dilution following the recent US$250 million equity raise. The market reaction so far suggests the news is taken as progress, but pivotal trial outcomes remain the critical variable.

On the other hand, shareholders still face the challenge of unprofitability after several years of trial progress. Mineralys Therapeutics' shares have been on the rise but are still potentially undervalued by 48%. Find out what it's worth.

Exploring Other Perspectives

MLYS Earnings & Revenue Growth as at Oct 2025
MLYS Earnings & Revenue Growth as at Oct 2025
With two fair value estimates from the Simply Wall St Community ranging widely between US$4.38 and US$43.75, opinions on Mineralys vary sharply. Some see significant upside, but the outsized year-to-date price surge means trial results will be the main driver from here. These contrasting views highlight how volatile sentiment can be ahead of major catalysts.

Explore 2 other fair value estimates on Mineralys Therapeutics - why the stock might be worth as much as $43.75!

Build Your Own Mineralys Therapeutics Narrative

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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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About NasdaqGS:MLYS

Mineralys Therapeutics

A clinical-stage biopharmaceutical company, develops medicines to target diseases driven by dysregulated aldosterone in the United States.

Flawless balance sheet with moderate risk.

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