Why Mineralys Therapeutics (MLYS) Is Up After Positive Phase 3 Lorundrostat Data and FDA Filing Plans

• Mineralys Therapeutics recently reported positive pivotal Phase 3 data for its lead candidate lorundrostat in chronic kidney disease and hypertension, showing statistically significant reductions in blood pressure and albuminuria, as presented at ASN Kidney Week 2025.
• Importantly, the company disclosed plans to file a New Drug Application for lorundrostat with the FDA by early 2026, highlighting a potential milestone for its pipeline.
• We’ll explore how the strong late-stage clinical results for lorundrostat could reshape Mineralys Therapeutics' investment narrative and pipeline outlook.

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What Is Mineralys Therapeutics' Investment Narrative?

For anyone considering Mineralys Therapeutics, the belief centers on lorundrostat's clinical and commercial potential as a treatment for hard-to-manage hypertension and chronic kidney disease. The recent pivotal Phase 3 data presented at ASN Kidney Week 2025, showing statistically meaningful reductions in blood pressure and albuminuria, meaningfully advances the core investment story, and brings an FDA New Drug Application filing into clearer view by early 2026. This visibility into late-stage progress is now the most important short-term catalyst, potentially shifting attention from lingering concerns about recurring losses and ongoing cash burn. Although some risk remains around regulatory outcomes and eventual commercial uptake, this news likely reduces uncertainty regarding lorundrostat’s efficacy, which may improve sentiment and risk outlook compared to previous analysis. Still, the share price remains volatile, and Mineralys is not yet profitable or generating revenue, key facts for shareholders to weigh.

But risks around future profitability and regulatory approval are still crucial considerations for investors. Despite retreating, Mineralys Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much.

Exploring Other Perspectives

Among four fair value opinions from the Simply Wall St Community, numbers range from as low as US$15.38 to a high of US$153.81 per share. While clinical milestones strengthen the near-term story, ongoing uncertainty over profitability and regulatory hurdles leaves plenty of room for differing outlooks on long-term performance. Wide opinion gaps like this reflect how differently investors may view potential upside versus risk.

Explore 4 other fair value estimates on Mineralys Therapeutics - why the stock might be worth less than half the current price!

Build Your Own Mineralys Therapeutics Narrative

Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Mineralys Therapeutics research is our analysis highlighting 2 key rewards and 4 important warning signs that could impact your investment decision.
• Our free Mineralys Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Mineralys Therapeutics' overall financial health at a glance.

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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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