Mineralys Therapeutics Shares Surge 203.4%, NDA Submission Expected in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 26 2025
0mins
Should l Buy MLYS?
Source: NASDAQ.COM
- Outstanding Stock Performance: Mineralys Therapeutics has seen its stock price soar by 203.4% in 2025, reflecting strong market confidence in its product candidate lorundrostat, which is expected to drive further growth in 2026.
- Successful Clinical Trials: In the first half of 2025, the pivotal Phase III Launch-HTN and Phase II Advance-HTN studies for lorundrostat met their primary efficacy endpoints, indicating its potential as a best-in-class treatment for resistant hypertension, which could significantly enhance the company's market position.
- NDA Submission Preparation: The company is gearing up to submit a New Drug Application (NDA) for lorundrostat in early 2026, paving the way for market entry and potentially boosting revenue and market share significantly.
- Multiple Research Advancements: Mineralys has also completed enrollment in the Phase II Explore-OSA study for lorundrostat in overweight and obese patients with moderate-to-severe OSA, with top-line data expected in Q1 2026, further strengthening its competitive edge in the market.
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Analyst Views on MLYS
Wall Street analysts forecast MLYS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MLYS is 52.60 USD with a low forecast of 46.00 USD and a high forecast of 56.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 28.210
Low
46.00
Averages
52.60
High
56.00
Current: 28.210
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.
Medical Properties Trust Options Volume Surges 120.3% Today
- Surge in Options Volume: Medical Properties Trust Inc (MPW) has seen an options volume of 76,796 contracts today, equating to approximately 7.7 million shares, which represents a significant 120.3% increase over its average daily trading volume, indicating heightened market interest in the stock.
- High-Frequency Trading Insight: Among these contracts, the $5.50 strike call option expiring on January 9, 2026, has been particularly active with 51,506 contracts traded, representing about 5.2 million underlying shares of MPW, suggesting a bullish sentiment among investors regarding future price movements.
- Market Dynamics: In comparison, Papa John's International, Inc. (PZZA) has recorded an options trading volume of 8,122 contracts today, representing approximately 812,200 shares, reflecting a 119.1% increase in trading volume and indicating active market engagement with the stock.
- Investor Sentiment: The $32.50 strike put option for PZZA expiring on February 20, 2026, has seen a trading volume of 6,108 contracts, representing about 610,800 shares, which suggests a cautious outlook among investors regarding the company's future performance.
See More
Mineralys Highlights Lorundrostat Clinical Progress, Anticipates 2026 Data Release
- Clinical Trial Progress: Mineralys Therapeutics completed enrollment for the Phase 2 Explore-OSA trial in Q3 2025, with topline results expected in Q1 2026, aimed at evaluating lorundrostat's efficacy in hypertensive patients with obstructive sleep apnea, potentially reinforcing its market position in hypertension treatment.
- New Drug Application Submission: The company submitted an NDA for lorundrostat to the FDA in late 2025, following three positive clinical trials demonstrating best-in-class safety and 24-hour blood pressure control across diverse patient populations, which is expected to enhance its recognition in the hypertension treatment market.
- Long-term Safety Study: The ongoing Transform-HTN open-label extension trial allows participants to continue receiving lorundrostat, aimed at gathering additional long-term safety and efficacy data to support future market launch efforts.
- Positive CKD Trial Results: The Explore-CKD Phase 2 trial showed that lorundrostat met its primary endpoint by significantly reducing systolic blood pressure and proteinuria in patients with hypertension, reduced kidney function, and albuminuria, further validating its potential in treating related diseases.
See More
Mineralys Therapeutics (MLYS) Shares Oversold with RSI at 29.3
- Oversold Signal: Mineralys Therapeutics (MLYS) shares have dropped to $35.48, with an RSI of 29.3, indicating that the recent heavy selling may be exhausting, prompting bullish investors to seek buying opportunities.
- Historical Performance Comparison: Over the past year, MLYS shares have seen a low of $8.241 and a high of $47.65, with the current trading price at $35.50, reflecting significant volatility that requires careful risk assessment by investors.
- Market Sentiment Analysis: Compared to the S&P 500 ETF (SPY) with an RSI of 55.2, MLYS's oversold condition may attract bullish investors' attention, potentially leading to a short-term rebound.
- Investment Opportunity Assessment: In an oversold scenario, investors should monitor MLYS's fundamentals and market dynamics to strategically invest at the right moment, capturing potential recovery opportunities.
See More
Mineralys Therapeutics Inc Offers 16.1% Annualized Return on $22.50 Put Option
- Options Yield Analysis: Mineralys Therapeutics Inc's $22.50 put option offers a 16.1% annualized return, but it will only be exercised if the stock price declines by 39.4%, resulting in a cost basis of $20.80 per share, highlighting the complex relationship between risk and reward in options trading.
- Market Volatility Consideration: The company's trailing twelve-month stock price volatility stands at 97%, indicating that with the current price at $37.05, option sellers must carefully assess how market fluctuations could impact potential returns when weighing the associated risks.
- Investment Strategy Recommendation: Investors should evaluate whether selling the June 2026 put option at a $22.50 strike price provides a reasonable risk-reward ratio, especially in a high-volatility environment, by considering Mineralys's historical trading data alongside fundamental analysis.
- Options Market Dynamics: While the only profit for put sellers comes from collecting the option premium, changes in market conditions could influence their decisions, necessitating close monitoring of market trends to optimize investment strategies.
See More
UnitedHealth Group Options Volume Surges to 67,042 Contracts
- Surge in Options Volume: UnitedHealth Group (UNH) sees an options volume of 67,042 contracts today, equating to approximately 6.7 million shares, which represents a significant 106.2% of its average daily trading volume over the past month, indicating strong market interest in its future performance.
- High-Frequency Trading Insights: Notably, the $330 strike call option expiring on December 26, 2025, has traded 5,018 contracts today, representing about 501,800 shares of UNH, suggesting bullish sentiment among investors at this price level.
- Increased Market Activity: In comparison, Mineralys Therapeutics Inc (MLYS) has an options volume of 15,285 contracts today, approximately 1.5 million shares, which is close to 98.8% of its average daily trading volume over the past month, indicating investor interest in this company as well.
- Investor Sentiment Analysis: The $60 strike call option for MLYS expiring on March 20, 2026, has seen a trading volume of 5,108 contracts today, representing around 510,800 shares, reflecting positive market expectations regarding its future potential.
See More
Mineralys Therapeutics Shares Surge 203.4%, NDA Submission Expected in 2026
- Outstanding Stock Performance: Mineralys Therapeutics has seen its stock price soar by 203.4% in 2025, reflecting strong market confidence in its product candidate lorundrostat, which is expected to drive further growth in 2026.
- Successful Clinical Trials: In the first half of 2025, the pivotal Phase III Launch-HTN and Phase II Advance-HTN studies for lorundrostat met their primary efficacy endpoints, indicating its potential as a best-in-class treatment for resistant hypertension, which could significantly enhance the company's market position.
- NDA Submission Preparation: The company is gearing up to submit a New Drug Application (NDA) for lorundrostat in early 2026, paving the way for market entry and potentially boosting revenue and market share significantly.
- Multiple Research Advancements: Mineralys has also completed enrollment in the Phase II Explore-OSA study for lorundrostat in overweight and obese patients with moderate-to-severe OSA, with top-line data expected in Q1 2026, further strengthening its competitive edge in the market.
See More
Medical Properties Trust Options Volume Surges 120.3% Today
- Surge in Options Volume: Medical Properties Trust Inc (MPW) has seen an options volume of 76,796 contracts today, equating to approximately 7.7 million shares, which represents a significant 120.3% increase over its average daily trading volume, indicating heightened market interest in the stock.
- High-Frequency Trading Insight: Among these contracts, the $5.50 strike call option expiring on January 9, 2026, has been particularly active with 51,506 contracts traded, representing about 5.2 million underlying shares of MPW, suggesting a bullish sentiment among investors regarding future price movements.
- Market Dynamics: In comparison, Papa John's International, Inc. (PZZA) has recorded an options trading volume of 8,122 contracts today, representing approximately 812,200 shares, reflecting a 119.1% increase in trading volume and indicating active market engagement with the stock.
- Investor Sentiment: The $32.50 strike put option for PZZA expiring on February 20, 2026, has seen a trading volume of 6,108 contracts, representing about 610,800 shares, which suggests a cautious outlook among investors regarding the company's future performance.
See More
Mineralys Highlights Lorundrostat Clinical Progress, Anticipates 2026 Data Release
- Clinical Trial Progress: Mineralys Therapeutics completed enrollment for the Phase 2 Explore-OSA trial in Q3 2025, with topline results expected in Q1 2026, aimed at evaluating lorundrostat's efficacy in hypertensive patients with obstructive sleep apnea, potentially reinforcing its market position in hypertension treatment.
- New Drug Application Submission: The company submitted an NDA for lorundrostat to the FDA in late 2025, following three positive clinical trials demonstrating best-in-class safety and 24-hour blood pressure control across diverse patient populations, which is expected to enhance its recognition in the hypertension treatment market.
- Long-term Safety Study: The ongoing Transform-HTN open-label extension trial allows participants to continue receiving lorundrostat, aimed at gathering additional long-term safety and efficacy data to support future market launch efforts.
- Positive CKD Trial Results: The Explore-CKD Phase 2 trial showed that lorundrostat met its primary endpoint by significantly reducing systolic blood pressure and proteinuria in patients with hypertension, reduced kidney function, and albuminuria, further validating its potential in treating related diseases.
See More
Mineralys Therapeutics (MLYS) Shares Oversold with RSI at 29.3
- Oversold Signal: Mineralys Therapeutics (MLYS) shares have dropped to $35.48, with an RSI of 29.3, indicating that the recent heavy selling may be exhausting, prompting bullish investors to seek buying opportunities.
- Historical Performance Comparison: Over the past year, MLYS shares have seen a low of $8.241 and a high of $47.65, with the current trading price at $35.50, reflecting significant volatility that requires careful risk assessment by investors.
- Market Sentiment Analysis: Compared to the S&P 500 ETF (SPY) with an RSI of 55.2, MLYS's oversold condition may attract bullish investors' attention, potentially leading to a short-term rebound.
- Investment Opportunity Assessment: In an oversold scenario, investors should monitor MLYS's fundamentals and market dynamics to strategically invest at the right moment, capturing potential recovery opportunities.
See More
Mineralys Therapeutics Inc Offers 16.1% Annualized Return on $22.50 Put Option
- Options Yield Analysis: Mineralys Therapeutics Inc's $22.50 put option offers a 16.1% annualized return, but it will only be exercised if the stock price declines by 39.4%, resulting in a cost basis of $20.80 per share, highlighting the complex relationship between risk and reward in options trading.
- Market Volatility Consideration: The company's trailing twelve-month stock price volatility stands at 97%, indicating that with the current price at $37.05, option sellers must carefully assess how market fluctuations could impact potential returns when weighing the associated risks.
- Investment Strategy Recommendation: Investors should evaluate whether selling the June 2026 put option at a $22.50 strike price provides a reasonable risk-reward ratio, especially in a high-volatility environment, by considering Mineralys's historical trading data alongside fundamental analysis.
- Options Market Dynamics: While the only profit for put sellers comes from collecting the option premium, changes in market conditions could influence their decisions, necessitating close monitoring of market trends to optimize investment strategies.
See More
UnitedHealth Group Options Volume Surges to 67,042 Contracts
- Surge in Options Volume: UnitedHealth Group (UNH) sees an options volume of 67,042 contracts today, equating to approximately 6.7 million shares, which represents a significant 106.2% of its average daily trading volume over the past month, indicating strong market interest in its future performance.
- High-Frequency Trading Insights: Notably, the $330 strike call option expiring on December 26, 2025, has traded 5,018 contracts today, representing about 501,800 shares of UNH, suggesting bullish sentiment among investors at this price level.
- Increased Market Activity: In comparison, Mineralys Therapeutics Inc (MLYS) has an options volume of 15,285 contracts today, approximately 1.5 million shares, which is close to 98.8% of its average daily trading volume over the past month, indicating investor interest in this company as well.
- Investor Sentiment Analysis: The $60 strike call option for MLYS expiring on March 20, 2026, has seen a trading volume of 5,108 contracts today, representing around 510,800 shares, reflecting positive market expectations regarding its future potential.
See More
Mineralys Therapeutics Shares Surge 203.4%, NDA Submission Expected in 2026
- Outstanding Stock Performance: Mineralys Therapeutics has seen its stock price soar by 203.4% in 2025, reflecting strong market confidence in its product candidate lorundrostat, which is expected to drive further growth in 2026.
- Successful Clinical Trials: In the first half of 2025, the pivotal Phase III Launch-HTN and Phase II Advance-HTN studies for lorundrostat met their primary efficacy endpoints, indicating its potential as a best-in-class treatment for resistant hypertension, which could significantly enhance the company's market position.
- NDA Submission Preparation: The company is gearing up to submit a New Drug Application (NDA) for lorundrostat in early 2026, paving the way for market entry and potentially boosting revenue and market share significantly.
- Multiple Research Advancements: Mineralys has also completed enrollment in the Phase II Explore-OSA study for lorundrostat in overweight and obese patients with moderate-to-severe OSA, with top-line data expected in Q1 2026, further strengthening its competitive edge in the market.
See More
