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An announcement from Mineralys Therapeutics, Inc. ( (MLYS) ) is now available.
On January 6, 2026, Mineralys Therapeutics provided a corporate update detailing significant recent clinical and regulatory milestones for its lead drug candidate, lorundrostat, and announced management’s participation in the LifeSci Partners Corporate Access event scheduled for January 12-14, 2026, in San Francisco. The company disclosed that it had filed a new drug application for lorundrostat with the U.S. Food and Drug Administration in late 2025, following a series of positive clinical readouts, including successful pivotal trials (Launch-HTN and Advance-HTN) in uncontrolled and resistant hypertension and favorable Phase 2 data in chronic kidney disease, as well as ongoing long-term safety evaluation via the Transform-HTN open-label extension. Mineralys also confirmed it remained on track to report topline results in the first quarter of 2026 from its Phase 2 Explore-OSA trial in patients with moderate to severe obstructive sleep apnea and hypertension, a data event that could further support the drug’s positioning as a potential best-in-class therapy for hypertension and comorbid conditions and influence its future regulatory and commercial trajectory.
The most recent analyst rating on (MLYS) stock is a Hold with a $37.00 price target. To see the full list of analyst forecasts on Mineralys Therapeutics, Inc. stock, see the MLYS Stock Forecast page.
Spark’s Take on MLYS Stock
According to Spark, TipRanks’ AI Analyst, MLYS is a Neutral.
The score is held back mainly by weak financial performance (no revenue, large losses, and high cash burn) and soft technical momentum. These are partly offset by a strong earnings-call setup (pivotal trial success, clear NDA path, and cash runway into 2028) and a debt-free balance sheet, though valuation support is limited due to negative earnings and no dividend.
To see Spark’s full report on MLYS stock, click here.
More about Mineralys Therapeutics, Inc.
Mineralys Therapeutics, Inc., based in Radnor, Pennsylvania, is a clinical-stage biopharmaceutical company focused on developing medicines for hypertension and related comorbidities such as chronic kidney disease and obstructive sleep apnea, particularly diseases driven by dysregulated aldosterone. Its lead product candidate, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor designed to lower aldosterone levels and improve blood pressure control and related outcomes in difficult-to-treat patient populations.
Average Trading Volume: 1,489,117
Technical Sentiment Signal: Buy
Current Market Cap: $2.82B
Find detailed analytics on MLYS stock on TipRanks’ Stock Analysis page.