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Mineralys Therapeutics, Inc. ( (MLYS) ) has provided an update.
On March 6, 2026, Mineralys Therapeutics received U.S. Food and Drug Administration acceptance of its New Drug Application for lorundrostat to treat adult patients with hypertension in combination with other antihypertensive drugs, with a target action date set for December 22, 2026. The filing is supported by a clinical program showing clinically meaningful blood pressure reductions and a favorable safety profile, potentially advancing lorundrostat toward commercialization in the sizable uncontrolled and resistant hypertension segments if approved.
In a separate update on March 9, 2026, the company reported topline results from the Phase 2 Explore-OSA exploratory trial in overweight or obese adults with moderate-to-severe obstructive sleep apnea and hypertension, where lorundrostat failed to show a clinically meaningful improvement in apnea-hypopnea index versus placebo after four weeks. However, the study showed statistically and clinically significant reductions in blood pressure and maintained a favorable safety and tolerability profile, suggesting ongoing value for lorundrostat in difficult-to-control hypertensive populations even as its role in sleep apnea-specific endpoints remains unproven.
The most recent analyst rating on (MLYS) stock is a Buy with a $56.00 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 primarily by weak financial performance (no revenue, sizable ongoing losses and cash burn) and bearish near-term technicals. These are partially offset by a favorable earnings-call outlook highlighting strong clinical data and regulatory momentum toward an NDA, plus a sizable cash runway that reduces near-term funding risk.
To see Spark’s full report on MLYS stock, click here.
More about Mineralys Therapeutics, Inc.
Mineralys Therapeutics, Inc. is a Radnor, Pa.-based biopharmaceutical company focused on developing medicines for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea, as well as other conditions driven by dysregulated aldosterone. Its lead product candidate, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels and improve blood pressure control in uncontrolled or resistant hypertension.
The company has completed five Phase 2 and 3 clinical trials of lorundrostat, including pivotal Launch-HTN and Advance-HTN studies, which demonstrated robust, durable reductions in systolic blood pressure and a favorable safety profile, supporting aldosterone as a key therapeutic target. Mineralys, founded by Catalys Pacific and listed on Nasdaq under the ticker MLYS, is positioning lorundrostat as a potential new option in a large market where many patients fail to reach blood pressure goals on existing therapies.
Average Trading Volume: 1,260,965
Technical Sentiment Signal: Hold
Current Market Cap: $2.1B
For an in-depth examination of MLYS stock, go to TipRanks’ Overview page.