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H.C. Wainwright reiterated a Buy rating and $42.00 price target on Mineralys Therapeutics , Inc. (NASDAQ:MLYS) following positive results from the Phase 2 Explore-CKD trial. According to InvestingPro data, analysts maintain a Strong Buy consensus with targets ranging from $15 to $52, suggesting significant upside potential. The trial evaluated lorundrostat in chronic kidney disease patients with uncontrolled or resistant hypertension.
The Explore-CKD trial achieved its primary endpoint of systolic blood pressure change from baseline at week 4, demonstrating lorundrostat’s benefit for hypertension in broader comorbid populations such as CKD. While the company holds more cash than debt and maintains strong liquidity with a current ratio of 26.48, InvestingPro analysis indicates rapid cash burn requires monitoring. H.C. Wainwright believes these results, combined with prior pivotal success in uncontrolled and resistant hypertension, can support a robust NDA submission.
Mineralys plans to meet with the FDA during the fourth quarter of 2025 to discuss the regulatory pathway forward. The research firm views the 25mg dosing with meaningful blood pressure reduction as potentially beneficial for prescribing flexibility, building on the optimized 50mg once-daily dosing established in previous trials.
Regarding safety, H.C. Wainwright notes that hyperkalemia observations are expected and can be managed with potassium binders. The firm indicates that elevated potassium levels observed in the first 2-3 weeks of treatment are not reflective of an overall safety concern.
The research firm expressed enthusiasm about the Explore-CKD topline results and remains optimistic about lorundrostat’s prospects heading into the planned FDA discussions later in 2025. The stock has experienced an 18.38% gain over the past six months despite recent volatility. For deeper insights into MLYS’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, visit InvestingPro.
In other recent news, Mineralys Therapeutics reported a better-than-expected earnings per share (EPS) for the first quarter of 2025, posting a loss of $0.79 per share against an anticipated loss of $1.08. This development comes as the company highlighted significant progress in its product pipeline, particularly with its hypertension treatment, Lorundrostat. Mineralys also released positive topline data from its Phase 2 Explore-CKD trial for Lorundrostat, which met its primary endpoint in patients with hypertension and chronic kidney disease. The trial showed a 7.5 mmHg reduction in systolic blood pressure compared to placebo, alongside a favorable safety profile. Additionally, Jefferies analysts initiated coverage on Mineralys with a Hold rating, setting a price target of $15.00, reflecting cautious optimism about the company’s future prospects. In other updates, Mineralys announced plans to present data from its Phase 3 Launch-HTN trial at the upcoming European Meeting on Hypertension and Cardiovascular Protection. These developments are part of the company’s ongoing efforts to advance its treatment for cardiorenal conditions.
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