Mineralys Therapeutics Inc. (NASDAQ:MLYS) is one of the best high short interest stocks with biggest upside potential. On January 6, Mineralys Therapeutics announced the late 2025 filing of its NDA for lorundrostat. The company highlighted several clinical milestones, including the completion of three positive trials (Explore-CKD, Launch-HTN, and Advance-HTN), which demonstrated the drug’s 24-hour blood pressure control and safety across diverse patient populations. Additionally, Mineralys remains on track ...

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 ...

Core Insights - Mineralys (MLYS) has successfully navigated Phase 3 development and is transitioning to a pre-commercial organization, indicating progress in its development pipeline [1] Group 1: Company Overview - Mineralys is positioned in the biotech sector, which is characterized by significant binary risks associated with investment [1] - The company is focused on high-growth opportunities and disruptive technologies, aiming for substantial returns through innovation [1] Group 2: Investment Perspective - The analysis emphasizes a blend of fundamental analysis and future trend prediction as a strategy for identifying investment opportunities in high-growth sectors [1]

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]

Industry Overview - The drug and biotech sector experienced a volatile performance in 2025, with a significant recovery in the last months attributed to improved drug pricing policies and strong M&A activity, leading to a 26% rally in the biotech sector over the past six months, outperforming the S&P 500 index [1] - Innovation is expected to drive growth in key areas such as obesity, gene therapy, inflammation, and neuroscience, with the FDA approving 44 novel therapies as of December 22, 2025, and strong M&A activity anticipated to continue into 2026 [2] Company Highlights Mineralys Therapeutics (MLYS) - MLYS's product candidate, lorundrostat, is in development for uncontrolled hypertension, chronic kidney disease, and obstructive sleep apnea, with pivotal studies showing positive results and plans for NDA submission in early 2026 [6][8] - MLYS shares surged 203.4% year-to-date, supported by favorable regulatory updates and strong clinical data [9] - The company has narrowed its loss per share estimates for 2026 from $3.06 to $2.50 [10] Lyell Immunopharma (LYEL) - LYEL focuses on next-generation CAR T-cell therapies, with its lead candidate, ronde-cel, in pivotal studies for large B-cell lymphoma, and a second pivotal study expected to begin in early 2026 [11][14] - LYEL shares increased by 191.6% year-to-date, bolstered by a strong cash position of approximately $320 million as of September 30, 2025 [16] - Loss per share estimates for 2026 have narrowed from $12.68 to $9.70 [17] Insmed (INSM) - INSM 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 [18] - The FDA approved Brinsupri for non-CF bronchiectasis, with sales of $28.1 million in Q3 2025, although the company faced a setback with the failure of the BiRCh study [19][20] - INSM shares rose 156% year-to-date, with loss per share estimates for 2026 narrowing from $3.65 to $3.58 [22] Nektar Therapeutics (NKTR) - NKTR is developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with positive data from phase IIb studies supporting its advancement into phase III development in 2026 [23][25] - NKTR shares skyrocketed 218.8% year-to-date, with loss per share estimates for 2026 narrowing from $12.82 to $10.81 [27]

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]

Core Viewpoint - Mineralys Therapeutics, Inc. (MLYS) has seen a 5.1% increase in share price over the past four weeks, closing at $38.91, with a potential upside of 27.6% based on Wall Street analysts' mean price target of $49.63 [1] Price Targets - The average price target consists of eight estimates ranging from a low of $42.00 to a high of $56.00, with a standard deviation of $5.78, indicating variability among analysts [2] - The lowest estimate suggests a 7.9% increase from the current price, while the highest estimate indicates a 43.9% upside [2] Analyst Consensus and Earnings Estimates - Analysts are increasingly optimistic about MLYS's earnings prospects, as evidenced by a strong agreement in revising EPS estimates higher, which correlates with potential stock price increases [4][11] - Over the last 30 days, three earnings estimates have been revised upward, leading to a 6.7% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank - MLYS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] Price Movement Guidance - While the consensus price target may not be a reliable indicator of the extent of MLYS's potential gains, the implied direction of price movement appears to be a useful guide for investors [14]

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]