Mineralys Submits First NDA Application for Hypertension
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 12 2026
0mins
Should l Buy MLYS?
"Mineralys had a transformational year in 2025, defined by significant clinical progress and key regulatory milestones," said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. "We successfully completed multiple clinical trials, with results published in JAMA and The New England Journal of Medicine, highlighting the potential of lorundrostat to benefit patients with inadequately controlled hypertension. We also ended the year with the submission of our first NDA for the treatment of hypertension in adults. The FDA's acceptance of this application marked a significant milestone, and we look forward to working closely with the agency as lorundrostat advances toward potential approval and commercialization."
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Analyst Views on MLYS
Wall Street analysts forecast MLYS stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 27.090
Low
46.00
Averages
52.60
High
56.00
Current: 27.090
Low
46.00
Averages
52.60
High
56.00
About MLYS
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Lorundrostat is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. It has completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). It is also investigating the benefits of lorundrostat in subjects with hypertension and CKD and in subjects with hypertension and OSA.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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See More
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- Clinical Trial Results: In the Phase 2 Explore-OSA trial, although no clinically meaningful difference was observed in the primary endpoint, the significant reduction in blood pressure and favorable safety profile were deemed clinically meaningful, indicating the drug's potential in difficult-to-control hypertension patients.
- Market Outlook: The FDA has set a target action date of December 22, 2026, and if approved, this could open new revenue streams for the company and potentially secure a position in the competitive hypertension drug market.
- CEO Commentary: CEO Jon Congleton noted that despite the primary endpoint not being met, the drug's blood pressure-lowering effects and safety profile remain clinically significant, reflecting the company's ongoing commitment to developing new therapies.
See More
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- Clinical Trial Success: The NDA submission is supported by three positive clinical trials demonstrating Lorundrostat's safety and ability to control blood pressure over 24 hours, indicating its potential as a new treatment option for uncontrolled hypertension.
- Explore-OSA Trial Findings: Although the Explore-OSA trial did not show a significant reduction in the apnea-hypopnea index (AHI), Lorundrostat demonstrated clinically meaningful blood pressure reductions and a favorable safety profile, enhancing its prospects for use in difficult-to-treat hypertension patients.
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See More
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- Dell Options Volume: Dell Technologies saw options trading volume of 56,231 contracts, representing approximately 5.6 million shares, which is about 59.2% of its average daily trading volume over the past month, indicating heightened market interest in its future performance.
- High-Frequency Contracts: Notably, the $210 strike put option expiring March 19, 2027, has seen 5,000 contracts traded today, equating to approximately 500,000 shares, suggesting an increasing bearish sentiment among investors regarding Dell's stock price.
- Super Group Options Activity: Super Group Ltd recorded options trading volume of 12,084 contracts, representing around 1.2 million shares, which constitutes about 58.1% of its average daily trading volume over the past month, reflecting sustained market interest in the company.
- Bullish Call Options: Within Super Group, the $8.75 strike call option expiring April 17, 2026, has traded 6,499 contracts today, representing approximately 649,900 shares, indicating a bullish outlook among investors for the company's future stock performance.
See More
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- MLYS Stock Analysis: Mineralys Therapeutics Inc (MLYS) trades at $23.28, with an analyst target price of $50.00, suggesting a potential upside of 114.78%, which indicates strong market confidence in its future growth prospects.
- Q Company Outlook: Qnity Electronics, Inc. (Q) has a current share price of $111.94, with an analyst target price of $233.67, showing an upside of 108.74%, highlighting analysts' very optimistic expectations for its future performance.
- LIF Investment Potential: Life360 Inc (LIF) is currently priced at $39.27, with an analyst target price of $75.97, representing a potential upside of 93.45%, further emphasizing the market's positive outlook on the company.
See More
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- FDA NDA Acceptance: CEO Jon Congleton highlighted the FDA's acceptance of the NDA for lorundrostat, with a PDUFA target action date of December 22, 2026, marking a significant milestone that positions the company for rapid entry into the U.S. hypertension market.
- Improved Financial Position: As of December 31, 2025, the company reported cash and cash equivalents totaling $656.6 million, a substantial increase from $198.2 million in 2024, indicating sufficient funding for planned clinical trials and regulatory activities.
- Decrease in R&D Expenses: R&D expenses for 2025 were $132 million, down from $168.6 million in 2024, primarily due to the completion of the lorundrostat pivotal program, allowing the company to focus resources on market launch and commercialization strategies.
- Market Opportunity Outlook: Management reiterated the market potential for lorundrostat in patients with resistant hypertension, expecting rapid uptake post-approval while also evaluating further indications and potential partnerships for international expansion.
See More
Mineralys Therapeutics Q4 Earnings Beat Expectations
- Earnings Performance: Mineralys Therapeutics reported a Q4 GAAP EPS of -$0.40, beating market expectations by $0.13, indicating improved financial management that may bolster investor confidence.
- Significant Cash Reserves Growth: As of December 31, 2025, the company reported cash, cash equivalents, and investments totaling $656.6 million, a substantial increase from $198.2 million in 2024, reflecting a robust financial position that supports future R&D activities.
- Sufficient Funding for Future Plans: Mineralys believes its current cash reserves will adequately fund planned clinical trials and regulatory activities through 2028, laying a solid foundation for long-term growth and enhancing market confidence in its future prospects.
- Positive FDA Review Progress: The ongoing FDA review of its blood pressure drug has positively impacted Mineralys's market performance, signaling potential success in drug development and market entry strategies.
See More
FDA Accepts Marketing Application for Mineralys' Lorundrostat
- FDA Application Accepted: Mineralys Therapeutics' marketing application for lorundrostat has been accepted by the FDA, marking a significant advancement in the treatment of hypertension, which is expected to enhance market recognition and investor confidence.
- Clinical Trial Results: In the Phase 2 Explore-OSA trial, although no clinically meaningful difference was observed in the primary endpoint, the significant reduction in blood pressure and favorable safety profile were deemed clinically meaningful, indicating the drug's potential in difficult-to-control hypertension patients.
- Market Outlook: The FDA has set a target action date of December 22, 2026, and if approved, this could open new revenue streams for the company and potentially secure a position in the competitive hypertension drug market.
- CEO Commentary: CEO Jon Congleton noted that despite the primary endpoint not being met, the drug's blood pressure-lowering effects and safety profile remain clinically significant, reflecting the company's ongoing commitment to developing new therapies.
See More
Mineralys Therapeutics' NDA for Lorundrostat Accepted by FDA
- FDA Acceptance: Mineralys Therapeutics announced that the FDA has accepted its New Drug Application for Lorundrostat, with a decision expected on December 22, 2026, marking a significant step in the company's potential market entry for hypertension treatment.
- Clinical Trial Success: The NDA submission is supported by three positive clinical trials demonstrating Lorundrostat's safety and ability to control blood pressure over 24 hours, indicating its potential as a new treatment option for uncontrolled hypertension.
- Explore-OSA Trial Findings: Although the Explore-OSA trial did not show a significant reduction in the apnea-hypopnea index (AHI), Lorundrostat demonstrated clinically meaningful blood pressure reductions and a favorable safety profile, enhancing its prospects for use in difficult-to-treat hypertension patients.
- Upcoming Financial Results: The company is set to report its financial results for Q4 and the full year 2025 on March 12, 2026, with investors keenly awaiting insights into the financial implications of its drug development progress.
See More
