~ Late-breaking Phase 2 trial data evaluating the safety and efficacy of 25 mg of lorundrostat in participants with hypertension and comorbid CKD to be presented~~ Phase 3 data of the Launch-HTN Trial of lorundrostat to be included in “Best of Journal of the American Medical Association and the New England Journal of Medicine” presentation~ RADNOR, Pa., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines t ...

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Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Product**: Lorundrostat, an aldosterone synthase inhibitor targeting hypertension, particularly in patients with hyperaldosteronism-driven, uncontrolled, and resistant hypertension Key Points and Arguments 1. **Clinical Success**: Mineralys has achieved successful clinical outcomes in its pivotal program for lorundrostat, with an upcoming FDA filing and preparations for commercial launch expected soon [1][3] 2. **Target Population**: Approximately 30% of hypertension patients exhibit elevated or dysregulated aldosterone, confirming the need for aldosterone-targeted treatments [4] 3. **Market Approach**: The initial market strategy is to target fourth-line treatment for resistant hypertension, with plans to expand into third-line treatment over time [6][9] 4. **Guideline Inclusion**: The company is working closely with key opinion leaders to include lorundrostat in treatment guidelines, which is expected to be achievable based on rigorous trial data [7][8] 5. **Patient Population**: There are about 10 million potential patients with resistant hypertension in the U.S., with an additional 10 million in the third-line category [9][10] 6. **Safety and Efficacy Data**: The company does not anticipate additional incidences of hyperkalemia over time and plans to share comprehensive data with the FDA during the NDA submission [10][11] 7. **Competitive Landscape**: Recent phase three data on Baqsrostat showed comparable results to lorundrostat, but lorundrostat's profile is viewed favorably due to its efficacy and specificity [12][13] 8. **Partnership Opportunities**: Mineralys is open to partnerships to maximize the commercial potential of lorundrostat, especially given the focused nature of the prescribing physician base [18][19] 9. **Independent Launch Considerations**: While an independent launch is feasible, the company believes partnering would enhance market access and efficiency [20][21] 10. **Additional Indications**: Ongoing trials for chronic kidney disease (CKD) and obstructive sleep apnea (OSA) are aimed at establishing a broader treatment profile for lorundrostat [22][24] 11. **Future Development**: Heart failure is identified as a potential area for future research with aldosterone synthase inhibitors [25] 12. **Impact of Weight Loss Treatments**: The rise of GLP-1s and other weight loss treatments may affect the hypertension market, but there remains a significant opportunity for lorundrostat due to the prevalence of elevated aldosterone [26] Additional Important Insights - The company is focused on ensuring that lorundrostat is recognized as a viable treatment option for patients with comorbidities such as CKD and OSA [22][24] - The competitive landscape is evolving, and the company is prepared to address potential counter-detailing from competitors regarding treatment profiles [17] - The overall market for hypertension treatments remains robust, with a significant number of patients requiring effective management strategies [26]

Group 1 - Mergers and acquisitions (M&A) activity has increased significantly in 2025, with a 29% rise in deal value year-over-year and an 8% increase in the number of deals [3][4] - Electronic Arts is set to be taken private in the largest leveraged buyout ever, resulting in a stock price increase of over 20% in two days following the announcement [1] - Goldman Sachs predicts a further 15% growth in the number of M&A deals in 2026, driven by improving economic conditions and CEO confidence [4] Group 2 - A basket of potential M&A candidates has outperformed the S&P 1500 by seven percentage points since early September [2] - Goldman Sachs has identified six stocks with a 30% to 50% chance of being acquired in the next 12 months, highlighting their potential as M&A targets [3][4] - The identified stocks include companies from the health care sector, such as Insmed, Madrigal Pharmaceuticals, Krystal Biotech, Mineralys Therapeutics, and Vera Therapeutics, with varying market capitalizations and year-to-date total returns [5][6][7][8][9]

Core Insights - Mineralys Therapeutics has completed enrollment in its Phase 2 EXPLORE-OSA trial for lorundrostat, targeting patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension, with top-line results expected in Q1 2026 [1][2] - The trial aims to address the significant unmet need for effective treatments for patients suffering from OSA and hypertension, as current options are limited and often ineffective [2][3] - Lorundrostat is a selective aldosterone synthase inhibitor designed to reduce aldosterone levels, which are linked to hypertension and related comorbidities [8][9] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and OSA, driven by dysregulated aldosterone [9] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [9] Trial Details - The EXPLORE-OSA trial is a randomized, Phase 2 double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension [3] - Participants will receive 50 mg of lorundrostat or placebo, with the primary efficacy endpoint being the change in apnea-hypopnea index (AHI) after four weeks of treatment [3] Disease Context - OSA affects nearly one billion people globally, with 425 million cases classified as moderate-to-severe, and around 80% of adults with OSA remain undiagnosed [4] - Hypertension is a major health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [6] Market Opportunity - Between 30-50% of adults with hypertension have OSA, and this figure rises to 70-80% in those with resistant hypertension (rHTN) [5] - There is a significant opportunity for lorundrostat to address the needs of patients with both hypertension and OSA, particularly given the limitations of current treatment options [2][5]

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1][2]. Company Overview: Mineralys Therapeutics, Inc. (MLYS) - MLYS currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3]. - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for outperformance in the market [4]. Performance Metrics - Over the past week, MLYS shares increased by 1.83%, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 1.09% [6]. - In the last month, MLYS shares surged by 158.33%, significantly higher than the industry's 2.43% performance [6]. - Over the past quarter, MLYS shares have risen by 175.03%, and over the last year, they have gained 236.05%, while the S&P 500 increased by only 8.48% and 16.96%, respectively [7]. Trading Volume - MLYS has an average 20-day trading volume of 2,859,069 shares, indicating a bullish sign as the stock is rising with above-average volume [8]. Earnings Outlook - In the past two months, four earnings estimates for MLYS have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from -$3.26 to -$2.83 [10]. - For the next fiscal year, three estimates have also moved upwards, with no downward revisions noted [10]. Conclusion - Given the strong performance metrics and positive earnings outlook, MLYS is identified as a promising momentum pick with a Momentum Score of A and a Zacks Rank of 2 (Buy) [12].

Group 1 - Investors in the biotechnology sector have seen significant stock price increases, with Nektar Therapeutics and Mineralys Therapeutics both experiencing over 100% gains in the month leading up to September 19 [1] - Nektar Therapeutics' stock surged 108% from August 18 to September 18, driven by positive investor sentiment regarding its lead candidate, rezpegaldesleukin, an IL-2 pathway agonist [3][4] - In a phase 2b study for moderate to severe eczema, the highest dose of rezpegaldesleukin showed a 30% placebo-adjusted improvement, indicating potential competition with Dupixent, which generated $14.2 billion in sales last year [4][5] Group 2 - In the Rezolve-AD trial, 42% of patients achieved 75% skin clearance with rezpegaldesleukin compared to 17% in the placebo group, and in a longer treatment duration group, 62% achieved the same result [5][6] - Nektar Therapeutics currently has a market cap of $989 million, which is considered low for a company with a potential blockbuster treatment in mid-stage trials, although it has no products on the market [7] - A successful phase 3 trial for rezpegaldesleukin could significantly increase Nektar's stock value, but the company has not yet initiated a phase 3 program [9]

Momentum investing revolves around the idea of following a stock's recent trend in either direction. In "long context," investors will be essentially be "buying high, but hoping to sell even higher." With this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving that way. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Even though momentum is a popular stock characte ...

Core Viewpoint - The healthcare sector is experiencing significant stock price increases, with some stocks more than doubling in value since the end of July, indicating potential for further gains despite recent surges [1][2]. Group 1: Precigen - Precigen's shares increased by 155% from the end of July to September 5, following FDA approval for its first treatment, Papzimeos, which is aimed at recurrent respiratory papillomatosis (RRP) [4][5]. - Papzimeos is the first and only FDA-approved treatment for approximately 27,000 patients with RRP, with a notable response rate in clinical trials where 18 out of 35 patients avoided surgery for at least 12 months post-treatment [5][6]. - Analysts, including Swayampakula Ramakanth from HC Wainwright, have set a price target of $8.50 for Precigen, suggesting a potential 95% increase in the next year [6]. Group 2: Mineralys Therapeutics - Mineralys Therapeutics saw a 146% rise in stock price from the end of July to September 5, driven by a successful funding round for the development of its lead candidate, lorundrostat [7][8]. - The company raised $287.5 million through a secondary offering, which followed the suspension of an at-the-money equity offering [8]. - In a phase 3 trial, lorundrostat demonstrated a significant reduction in systolic pressure, outperforming a placebo [9]. - Following AstraZeneca's less favorable data for a competing product, Bank of America analyst Greg Harrison raised the target price for Mineralys to $43 per share, indicating a potential 24% gain [11]. - Despite the positive outlook, the company ended June with $325 million in cash, sufficient to last until 2027, raising concerns about the urgency of submitting for approval [12]. - Mineralys has a market cap of $2.7 billion, which could be affected by the timing of lorundrostat's approval compared to competitors [14]. Group 3: Market Potential - Precigen's market cap is approximately $1.3 billion, with expectations for Papzimeos potentially underestimated, as it is set to launch in a niche market without competition [15]. - Papzimeos could generate over $1 billion in annual sales at peak pricing, with a list price exceeding $200,000 per patient per year [16].