NEW YORK, December 30, 2025, 13:38 ET — Regular session
- Mineralys Therapeutics shares were down about 3.3% in early afternoon trade, underperforming biotech ETFs.
- Investors remain focused on the company’s planned FDA filing for lorundrostat and upcoming clinical readouts.
- The stock is well off its November peak, keeping technical levels and catalyst timing in the spotlight.
Shares of Mineralys Therapeutics Inc fell 3.3% to $35.61 by early afternoon on Tuesday, after touching a session low of $35.17. About 513,000 shares had changed hands, versus a previous close of $36.83.
Mineralys has a market value of about $2.9 billion and remains up about 183% over the past 52 weeks, even after sliding about 25% from its 52-week high set in November. Analysts expect the company to stay loss-making in the near term; Barchart shows an average quarterly EPS estimate of -$0.57 and an expected next earnings date of Feb. 11.
Investors have been positioning around the company’s next regulatory step for lorundrostat, its experimental blood-pressure drug. Mineralys said in November it plans to file a New Drug Application (NDA) for lorundrostat near the end of 2025 or in the first quarter of 2026, and expects topline results from its Phase 2 Explore-OSA study in the first quarter of 2026; CEO Jon Congleton said the company “anticipate(s) submitting near the end of 2025 or during the first quarter of 2026.” The company reported $593.6 million in cash, cash equivalents and investments as of Sept. 30 and said it expects that balance to fund operations into 2028. Mineralys Therapeutics, Inc.
The pullback came as biotech ETFs were lower, with the SPDR S&P Biotech ETF down about 1.3% and the iShares Nasdaq Biotechnology ETF off about 1.1%. Broader U.S. equity benchmarks were little changed, based on trading in SPY and QQQ.
Company filings have been quiet in recent weeks. Mineralys’ investor relations site shows the most recent SEC forms were insider ownership reports (Form 4) and proposed sale notices (Form 144) in late November.
Mineralys is a clinical-stage biopharmaceutical company focused on diseases driven by elevated aldosterone, a hormone that can contribute to high blood pressure. Its lead candidate, lorundrostat, is an aldosterone synthase inhibitor — a drug designed to reduce aldosterone production.
That setup leaves the stock sensitive to any shift in the timing of trial data, FDA interactions or commercialization plans. In clinical-stage biotech, those checkpoints often matter more than day-to-day market moves.
Competitive pressure is building. AstraZeneca said earlier this month it secured FDA priority review for a new drug application for baxdrostat, another aldosterone synthase inhibitor, in hard-to-control hypertension.
Wall Street remains broadly constructive: StockAnalysis.com lists a consensus price target of $47.33, which would imply roughly 33% upside from Tuesday’s levels. The spread highlights the tradeoff investors are pricing — optimism around a filing path, tempered by execution and timeline risk.
Traders now watch for confirmation that the NDA lands on the timeline the company outlined, and for details on how Mineralys plans to position lorundrostat commercially against larger rivals. Any update on the Explore-OSA readout, manufacturing plans or FDA feedback is likely to set the tone into early 2026.
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