RADNOR, Pa., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today issued a corporate update highlighting several recent and upcoming clinical and regulatory milestones. In addition, the Company announced that its management team will ...

Industry Overview - The drug and biotech sector experienced a volatile performance in 2025, with a significant recovery in the last few months attributed to improved drug pricing policies and strong merger and acquisition activity [2] - The biotech sector has rallied 26% over the past six months, outperforming the S&P 500 index [2] Innovation and Regulatory Activity - Key growth areas in the industry include obesity, gene therapy, inflammation, and neuroscience, attracting investor interest [3] - The FDA approved 44 novel therapies as of December 22, 2025, indicating healthy regulatory activity [3] Company Highlights Mineralys Therapeutics - Mineralys is developing lorundrostat, an aldosterone synthase inhibitor for uncontrolled hypertension, chronic kidney disease, and obstructive sleep apnea [5] - The pivotal phase III Launch-HTN study and phase II Advance-HTN study met primary efficacy endpoints, showing favorable safety [6] - The company plans to submit a new drug application for lorundrostat in early 2026, with shares up 203.4% year-to-date [8][9] Lyell Immunopharma - Lyell focuses on next-generation CAR T-cell therapies, with its lead candidate ronde-cel for large B-cell lymphoma [11] - A pivotal phase III study for ronde-cel is expected to begin in early 2026, and the company has a strong cash position of approximately $320 million [14] - Shares have increased by 191.6% in 2025, with loss per share estimates narrowing from $12.68 to $9.70 [15] Insmed - Insmed markets Arikayce for refractory MAC lung disease, generating $314.5 million in sales in the first nine months of 2025, a 21% increase year-over-year [16] - The FDA approved Brinsupri for non-CF bronchiectasis, with sales of $28.1 million in Q3 2025 [17] - Despite a setback with the BiRCh study, the company is evaluating Brinsupri for hidradenitis suppurativa, with shares up 156% year-to-date [19][20] Nektar Therapeutics - Nektar is developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with positive data from phase IIb studies [21][22] - The company plans to advance rezpeg into phase III development in 2026, with shares soaring 218.8% year-to-date [24][25]

Key Takeaways MLYS' lorundrostat hit key endpoints, supporting plans for an NDA submission in early 2026.LYEL rose as ronde-cel advanced in pivotal studies and new CAR T assets strengthened its oncology pipeline.INSM climbs on Brinsupri's FDA approval, despite a setback in a mid-stage rhinosinusitis study.The drug and biotech sector witnessed a see-saw performance in 2025. After a weak show for most of the year, the sector picked up in the past couple of months. This can be attributed to improved policies f ...

When a clinical-stage biotech is sitting on nearly $600 million in cash and lining up an FDA filing, sharp investors stop arguing about the past rally and start debating what comes next.On November 14, New York City-based Suvretta Capital Management disclosed a buy of 387,641 shares of Mineralys Therapeutics (MLYS 1.97%) that contributed to an overall position increase of about $57.25 million.What HappenedSuvretta Capital Management, a U.S.-based investment adviser, reported in a November 14 SEC filing that ...

Core Insights - Mineralys Therapeutics' Phase 3 Launch-HTN trial of lorundrostat for uncontrolled hypertension was recognized as one of the most impactful studies of 2025 by JAMA [1][2][3] - The trial demonstrated significant reductions in systolic blood pressure and a favorable safety profile, addressing a critical need for patients with treatment-resistant hypertension [3][4][6] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related conditions, including chronic kidney disease and obstructive sleep apnea [13] - The company's lead product, lorundrostat, is a highly selective aldosterone synthase inhibitor designed to target the root cause of hypertension by reducing aldosterone levels [11][12] Clinical Trial Details - The Launch-HTN trial involved 1,083 participants with uncontrolled or treatment-resistant hypertension, evaluating the efficacy and safety of lorundrostat when added to existing antihypertensive treatments [3][8] - Key findings included a 16.9 mmHg reduction in systolic blood pressure at Week 6 and a 19.0 mmHg reduction at Week 12, with statistically significant results (p-value < 0.0001) [6][8] - The trial's diverse participant demographics included a high proportion of women, Black or African American individuals, and elderly participants [3] Health Impact - Hypertension is a significant public health issue, contributing to over 685,000 deaths in the U.S. in 2022 and resulting in an estimated economic burden of $219 billion in 2019 [9][10] - Less than 50% of hypertension patients achieve their blood pressure goals with current medications, highlighting the need for new treatment options like lorundrostat [10] Future Developments - Lorundrostat is currently being evaluated in the ongoing Transform-HTN trial for long-term safety and efficacy, as well as in the Explore-OSA trial for its effects on obstructive sleep apnea [5][7]

Summary of Mineralys Therapeutics FY Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Focus**: Development of lorundrostat, an aldosterone synthase inhibitor for treating hypertension and related conditions Key Points Clinical Development and NDA Filing - Mineralys has built a comprehensive clinical development program in 2023 and 2024, with three significant data readouts this year [2][3] - Two pivotal studies, Advance-HTN and Launch-HTN, demonstrated profound reductions in blood pressure with a safe profile, forming the basis for the NDA application [2][3] - The NDA filing is anticipated by the end of 2025 or the first quarter of 2026, including data from pivotal studies and open-label extensions [5][15] Market Opportunity - There are approximately 20 million patients in the U.S. struggling to achieve blood pressure goals, representing a significant market for lorundrostat [3][9] - The target population includes patients on two or more medications who are not reaching their goals, specifically those with resistant hypertension [9] Commercial Strategy - An estimated 400 sales representatives may be needed to effectively reach the 60,000 doctors who control 50% of the prescription market for third-line hypertension treatments [9][10] - The company has $594 million in cash, which is expected to support pre-commercialization efforts and the launch through 2027, but will not lead to profitability [11][14] Competitive Landscape - Mineralys is preparing for competition with AstraZeneca's baxdrostat, which is expected to launch around Q2 2026 [20][22] - The company is focused on building awareness and enthusiasm for lorundrostat among healthcare providers and payers, emphasizing its clinical profile and benefits [22][26] Clinical Data and Efficacy - The clinical trials have shown not only blood pressure reduction but also benefits in proteinuria, which is critical for patients with comorbid conditions [26] - The diversity of the patient population in trials is highlighted, with significant representation of Black or African-American patients, which is crucial for addressing health disparities [26][27] Future Catalysts - The next significant data readout will be from the Explore OSA trial, expected in Q1 2026, which examines the drug's effects on patients with obstructive sleep apnea [28][29] Partnership and Development - Ongoing discussions for potential partnerships are focused on enhancing the value of lorundrostat and expanding its indication profile [38][39] - The company is evaluating various scenarios for commercialization and development partnerships, which could significantly impact capital needs [14][38] Regulatory Considerations - The company has been in discussions with the FDA regarding the long-term safety profile of lorundrostat, which is critical for the NDA submission [6][8] Conclusion - Mineralys Therapeutics is positioned to launch lorundrostat in a competitive market, with a strong clinical data set and a clear strategy for commercialization and market penetration. The upcoming NDA filing and ongoing clinical trials will be pivotal in determining the company's future success.

Core Insights - Findell Capital Management has initiated a new position in Mineralys Therapeutics, acquiring 250,000 shares valued at $9.5 million, representing 3.7% of its U.S. equity portfolio as of September 30 [2][6] - Mineralys Therapeutics has seen its share price increase by 246% over the past year, significantly outperforming the S&P 500's 13% gain during the same period [3] Company Overview - Mineralys Therapeutics is a clinical-stage biotechnology company focused on developing therapies for hypertension and cardiovascular diseases, specifically through its proprietary candidate, lorundrostat [5] - The company has a market capitalization of $3.4 billion and reported a net loss of $171.4 million over the trailing twelve months [4][5] - As of the latest market close, shares of Mineralys Therapeutics were priced at $43.36 [4] Financial Performance - Mineralys ended the third quarter with no product revenue and a net loss of $36.9 million, while continuing to advance its drug candidate lorundrostat [7] - The company raised $287.5 million through a recent offering, which has expanded its cash runway and indicated rising institutional support [6] Investment Context - The investment by Findell Capital reflects a high-risk, high-reward profile typical of pre-revenue biotech companies, with a focus on clinical progress and market momentum [6][8] - The company is still in the early stages of its lifecycle, primarily utilizing capital for research and development, manufacturing, and pre-commercial planning [7][8]

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension and related comorbidities, including chronic kidney disease and obstructive sleep apnea [3] Group 1: Stock Option Award - On November 24, 2025, the Compensation Committee of Mineralys granted an inducement stock option award covering 146,000 shares to a new non-executive employee [1] - The stock option will vest over a four-year period, with 25% vesting on the first anniversary and the remainder vesting monthly thereafter, contingent on continued service [2] - The award is part of the 2025 Employment Inducement Incentive Award Plan, aimed at attracting new employees [2] Group 2: Company Overview - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3] - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [3]

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS: MLYS) - **Focus**: Development of aldosterone synthase inhibitors (ASI) targeting cardiorenal metabolic disorders, primarily hypertension [1][2] Industry Context - **Market Opportunity**: Approximately 20 million patients in the U.S. suffer from resistant and uncontrolled hypertension, with 10 million specifically identified as resistant hypertension patients [4][5] - **Competitive Landscape**: The ASI class is emerging as a new treatment option for hypertension, with recent data from competitors like AstraZeneca's Baxdrostat [2][3] Key Clinical Data - **Clinical Trials**: Successful outcomes from pivotal studies LAUNCH HTN and ADVANCE HTN, with significant blood pressure reductions observed [1][2] - **Efficacy**: Lorundrostat demonstrated a 15-19 mmHg reduction in blood pressure compared to the typical 5 mmHg improvement seen with existing treatments [5][6] - **Patient Demographics**: Strong representation of Black or African American patients in trials, addressing a high-risk population for hypertension [9][10] Drug Profile - **Selectivity**: Lorundrostat shows a selectivity ratio of 374:1 for aldosterone over cortisol, compared to Baxdrostat's 101:1, indicating a better safety profile [11][12] - **Half-Life**: Lorundrostat has a half-life of 10-12 hours, aligning with the diurnal pattern of aldosterone secretion, which may enhance safety [12][13] - **Safety Signals**: Lower incidence of hyperkalemia compared to Baxdrostat, with 8% incidence above 5.5 mEq/L for lorundrostat versus 11% for Baxdrostat [15][16] Market Strategy - **Target Population**: Initial focus on resistant hypertension, with plans to expand into uncontrolled hypertension as prescriber comfort increases [27][30] - **Commercialization Approach**: Open to partnerships but emphasizes the importance of selecting the right partner to maximize the drug's potential [45][46] - **Market Size**: Targeting a broad market of 120 million people with hypertension, with a focus on the top 60,000 prescribers [46][47] Future Developments - **NDA Filing**: Anticipated NDA filing by the end of 2025, with ongoing collection of safety and efficacy data beyond the initial 12-week trials [37][38] - **Additional Studies**: Ongoing studies in chronic kidney disease (CKD) and obstructive sleep apnea (OSA) to explore additional benefits and potential label expansions [42][43] Conclusion - **Investment Potential**: Mineralys Therapeutics is positioned with a best-in-class molecule in a growing market, with strong clinical data supporting its efficacy and safety, making it a compelling investment opportunity in the pharmaceutical sector [19][50]

Summary of Mineralys Therapeutics FY Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS:MLYS) - **Event**: FY Conference on November 11, 2025 - **Key Speaker**: Jon Congleton, CEO Industry Context - **Industry**: Hypertension treatment and drug development - **Unmet Need**: Hypertension remains a leading modifiable risk factor globally, causing approximately 10.8 million deaths annually due to related comorbidities [4][5][6] Core Points and Arguments 1. **Hypertension Treatment Landscape**: - There has been a lack of innovation in hypertension treatments over the past 20-25 years, with existing therapies not adequately addressing patient needs, particularly regarding dysregulated aldosterone [5][36] - Current treatment goals have become more stringent, with the target blood pressure now set at 130/80 mmHg for most patients and 120 mmHg for those with comorbidities [5] 2. **Lorundrostat's Mechanism and Efficacy**: - Lorundrostat is positioned as a best-in-class aldosterone synthase inhibitor (ASI) with a selectivity ratio of 374:1 for aldosterone over cortisol, which is critical for minimizing side effects [9][42] - Clinical trials (ADVANCE HTN and LAUNCH HTN) show significant blood pressure reductions of 15-19 mmHg, which are transformative compared to typical improvements of 5-6 mmHg seen with other agents [15][31] 3. **Market Opportunity**: - The potential market for lorundrostat is estimated at 20 million patients in the U.S., with 10 million classified as resistant hypertension and another 10 million as uncontrolled hypertension [36][37] - There is a strong demand for innovative treatments, with 95% of surveyed physicians indicating intent to prescribe lorundrostat if available [38] 4. **Safety Profile**: - Lorundrostat has a favorable safety profile, with lower rates of hyperkalemia compared to competitors, which may be attributed to its selectivity and pharmacokinetics [41][42] 5. **Regulatory Timeline**: - Mineralys plans to file for regulatory approval by the end of 2025 or Q1 2026, with expectations of overlapping review cycles with competitors like AstraZeneca [43] Additional Important Insights - **Patient Demographics**: The ADVANCE HTN study included a significant proportion (53%) of Black or African American patients, who are known to have more challenging hypertension profiles [28] - **Measurement Techniques**: The study utilized multiple blood pressure measurement methods, including 24-hour ambulatory monitoring, to ensure accurate assessment of treatment efficacy [16][17] - **Physician Engagement**: The company has conducted market research indicating that physicians are primarily focused on absolute blood pressure changes rather than placebo-adjusted figures, which influences prescribing behavior [31][32] This summary encapsulates the key points discussed during the conference call, highlighting the strategic positioning of Mineralys Therapeutics in the hypertension treatment landscape and the promising potential of lorundrostat as a novel therapeutic option.