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Investing.com - Jefferies has reiterated its Hold rating and $15.00 price target on Mineralys Therapeutics , Inc. (NASDAQ:MLYS), which currently trades near InvestingPro’s Fair Value estimate, following competitor AstraZeneca (NASDAQ:AZN)’s positive Phase III data announcement for baxdrostat. The stock has shown strong momentum with a nearly 59% gain over the past six months.
The detailed efficacy and hyperkalemia data from AstraZeneca’s trial remain embargoed until the European Society of Cardiology conference on August 30. Jefferies notes that both companies’ aldosterone synthase inhibitors (ASIs) likely have comparable efficacy and safety profiles.
Mineralys has indicated interest in finding a commercial partner for territories outside the United States and potentially within the U.S. market as well. The upcoming detailed data from AstraZeneca could influence partnering discussions for Mineralys’s lorundrostat.
Jefferies identifies limited catalysts for Mineralys over the next 12-18 months, with key upcoming events including an FDA meeting in Q4 2025, potential Phase II OSA-HTN data in late 2025 or early 2026, and possible partnering announcements.
The research firm notes Mineralys had $343 million cash at the end of Q1 2025 but faces a quarterly burn rate of $30-40 million, suggesting the company will need additional financing before its anticipated H1 2027 U.S. launch, either through equity, debt, or partnership deals.
In other recent news, Mineralys Therapeutics has announced positive results from its Phase 3 Launch-HTN trial for lorundrostat, a drug aimed at treating hypertension. This trial, which included 1,083 participants, showed a significant reduction in systolic blood pressure when lorundrostat was added to existing treatments. Additionally, Mineralys reported successful outcomes from its Phase 2 Explore-CKD trial, demonstrating a clinically meaningful reduction in blood pressure and improvements in kidney function for patients with chronic kidney disease. Following these results, H.C. Wainwright reiterated a Buy rating for Mineralys, highlighting the potential for a strong new drug application submission. Jefferies, however, initiated coverage with a Hold rating, citing potential access challenges and competition. The company plans to meet with the FDA in 2025 to discuss regulatory pathways for lorundrostat. These developments mark significant progress in Mineralys’s efforts to address hypertension and related conditions.
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