Why Mineralys Therapeutics (MLYS) Is Up 5.8% After Strong Phase 3 Hypertension Data and FDA Update

• Earlier this month, Mineralys Therapeutics announced new subgroup results from its Phase 3 Launch-HTN trial of lorundrostat, highlighting consistent and meaningful blood pressure reductions with favorable safety outcomes.
• An important insight is the company's plan for a pre-NDA meeting with the FDA in late 2025 and an NDA filing as early as the first quarter of 2026, signaling clear progress toward regulatory submission and potential commercialization.
• We will explore how these positive Phase 3 results and defined regulatory plans could influence Mineralys Therapeutics' investment narrative.

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What Is Mineralys Therapeutics' Investment Narrative?

For investors interested in Mineralys Therapeutics, the story continues to hinge on confidence in lorundrostat and the company’s ability to address resistant hypertension in high-risk populations. The recent subgroup data from the Phase 3 Launch-HTN trial builds on prior results and may shift some near-term catalysts closer, as the clear efficacy and safety profile should bolster the path toward a regulatory submission. The company’s planned pre-NDA meeting with the FDA in late 2025 and the possibility of an NDA filing as early as the first quarter of 2026 are now more firmly in view. That said, financial risk remains substantial: Mineralys is unprofitable, faces ongoing cash burn, and has seen recent equity dilution. While the positive clinical news helps reduce regulatory risk, investors should still weigh share price volatility, unprofitability, and further dilution as active concerns. On the flip side, equity dilution has been significant and may continue if Mineralys needs more capital.

Mineralys Therapeutics' shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

Exploring Other Perspectives

The Simply Wall St Community shared two fair value estimates for Mineralys, with projections ranging from US$4.38 to US$43.75. Such varied viewpoints highlight how market participants can interpret the same clinical milestones and ongoing unprofitability very differently. Dive into these and compare how your own view stacks up.

Explore 2 other fair value estimates on Mineralys Therapeutics - why the stock might be worth as much as 11% more than 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 5 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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