Core Insights - TimesSquare Capital Management's "U.S. Small Cap Growth Strategy" reported a gross return of 2.26% and a net return of 2.01% for Q3 2025, significantly underperforming the Russell 2000 Growth Index, which returned 12.19% [1] - The fund's top five holdings were highlighted, indicating its best investment picks for 2025 [1] Company Analysis - NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) is a late-stage biopharmaceutical firm focused on cholesterol inhibitors for cardiovascular diseases [3] - The stock of NewAmsterdam Pharma experienced a one-month decline of 3.79% but has gained 28.57% over the past 52 weeks, closing at $33.48 per share with a market capitalization of $3.796 billion as of January 5, 2026 [2] - NewAmsterdam's lead candidate, a CETP inhibitor, demonstrated significant LDL level reductions without adverse side effects, contributing to a 57% increase in its share price [3] Investment Sentiment - NewAmsterdam Pharma was held by 28 hedge fund portfolios at the end of Q3 2025, a decrease from 31 in the previous quarter, indicating a slight decline in popularity among hedge funds [4] - Despite the potential of NewAmsterdam as an investment, the company is viewed as having less upside compared to certain AI stocks, which are considered to carry less downside risk [4]

Core Insights - The article highlights stocks reaching new 52-week highs, indicating market recognition of strong fundamentals and potential catalysts for growth [1][2]. Company Summaries Cogent Biosciences Inc. (COGT) - Cogent Biosciences plans to file its first New Drug Application for Bezuclastinib by the end of 2025, targeting non-advanced systemic mastocytosis [3]. - A phase III trial comparing Bezuclastinib with Sutent is ongoing, with results expected in the second half of 2025 [4]. - The stock reached a 52-week high of $16.99, up from $7.25 when last featured [5]. Assembly Biosciences Inc. (ASMB) - Assembly Biosciences is advancing four key development programs, with ABI-5366 expected to enter phase 2 studies in mid-2026 [6]. - Interim data for ABI-1179 is anticipated this fall, while ABI-6250 is in a phase 1a trial [7]. - The stock hit a 52-week high of $28, up from $14.53 when last featured [8]. Compass Therapeutics Inc. (CMPX) - Compass Therapeutics is conducting a phase 2/3 study of Tovecimig for advanced biliary tract cancer, with analyses of secondary endpoints expected in Q1 2026 [9][10]. - The stock reached a 52-week high of $4.39, up from $2.91 when last featured [11]. NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam Pharma is developing Obicetrapib as a cholesterol-lowering therapy, with positive data from the BROADWAY trial [12][13]. - The company has completed two additional phase III trials and submitted marketing applications to the EMA [16]. - The stock reached a 52-week high of $39.76, up from $21.56 when last featured [17]. Mineralys Therapeutics Inc. (MLYS) - Mineralys is developing Lorundrostat for uncontrolled hypertension, with a pivotal phase III trial achieving its primary endpoint [19]. - A phase II trial for overweight participants with OSA is ongoing, with topline results expected in 1H 2026 [20]. - The stock hit a 52-week high of $43.88, up from $10.34 when last featured [20]. Kymera Therapeutics Inc. (KYMR) - Kymera is set to report data from its phase I trial of KT-621 this quarter, with phase 2b studies planned for late 2025 and early 2026 [21][22]. - The stock reached a 52-week high of $60, up from $40 when last featured [22]. Insmed Inc. (INSM) - Insmed has two approved drugs and is conducting a phase 3 trial of Arikayce, with topline results expected in 1H 2026 [24][25]. - The stock hit a high of $166.54, up from $76.54 when last featured [26]. Adaptive Biotechnologies Corp. (ADPT) - Adaptive Biotechnologies expects MRD revenue between $190 million and $200 million for 2025, up from $145.5 million in 2024 [28][29]. - The stock reached a 52-week high of $15.94, up from $9.80 when last featured [29]. BridgeBio Pharma Inc. (BBIO) - BridgeBio has upcoming topline results from the FORTIFY and CALIBRATE studies expected in Fall 2025 [30]. - The stock reached a 3-year high of $56.24, up from $25.10 when last featured [31]. Tarsus Pharmaceuticals Inc. (TARS) - Tarsus reported strong sales for Xdemvy, with Q2 2025 sales of $102.7 million, compared to $40.8 million in Q2 2024 [32]. - The stock hit an all-time high of $70.15, up from $25.01 when last featured [34]. Palvella Therapeutics Inc. (PVLA) - Palvella's QTORIN is under development for various skin diseases, with a phase 2 trial expected to report data in mid-December 2025 [35][36]. - The stock reached a 52-week high of $76.76, up from $25 when last featured [36]. Merus N.V. (MRUS) - Merus agreed to be acquired by Genmab for $97 per share, with the deal expected to close in early Q1 2026 [37]. - The stock was at $39.71 when last featured [39]. Nephros Inc. (NEPH) - Nephros reported net revenue of $4.4 million for Q2 2025, marking its third consecutive quarter of profitability [40][41]. - The stock hit a 52-week high of $5.98, up from $2.93 when last featured [42].

Core Insights - Several healthcare and biotech stocks saw significant price movements in after-hours trading on September 12, with notable gains in companies like Penumbra, Check-Cap, Adaptimmune Therapeutics, and NewAmsterdam Pharma, indicating a volatile session for the sector [1] Company Summaries Penumbra Inc. (PEN) - Penumbra's stock closed at $272.73 during regular trading, down by $3.67 or 1.33%, but rebounded to $289.86 in after-hours, gaining 6.28% [2] - The trading range for the day was $271.83 to $280.14, with a volume of 454,478 shares, slightly below its average of 472,087 [3] - The company has a market capitalization of approximately $10.64 billion and a trailing price-to-earnings ratio of 71.96 based on earnings per share of $3.79 [3] - Penumbra raised its full-year 2025 revenue guidance to $1.355 billion - $1.370 billion, reflecting a growth of 13% - 15% over 2024 revenue of $1.195 billion, and projects a 20% - 21% growth in its U.S. thrombectomy segment [5] - The company appointed Shruthi Narayan as its new president, indicating potential strategic shifts [6] Check-Cap Ltd. (CHEK) - Check-Cap's stock surged from $0.7459 to $2.1600 in after-hours trading, marking a gain of 191.22%, driven by a strategic merger announcement [6] - During regular trading, the stock gained 8.09%, closing at $0.7459, with a trading range of $0.6860 to $0.7602 and a volume of 67,178 shares [7] - The merger with MBody AI aims to enhance Check-Cap's colorectal cancer screening capabilities through AI integration [8] Adaptimmune Therapeutics plc (ADAP) - Adaptimmune's stock rose from $0.0560 to $0.0651 in after-hours trading, a gain of 16.25%, following a 10.89% increase during regular hours [8] - For Q2 2025, the company reported a net loss of $30.3 million, or $0.02 per share, with total revenue of $13.7 million, primarily from product sales of TECELRA [9] - Adaptimmune entered a definitive agreement to sell certain cell therapies for $55 million upfront, with potential future milestone payments of up to $30 million, allowing it to repay debt and restructure for value maximization [10] NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam's shares rose from $24.19 to $26.18 in after-hours trading, an 8.23% gain, following a 9.06% decline during the day [11] - The stock's recovery is attributed to optimism surrounding its lead candidate, obicetrapib, which has received regulatory review acceptance from the EMA [11] - The company reported Q2 2025 revenue of $16.45 million and a net loss of $14.92 million, improving from a $0.41 loss per share in the same quarter of 2024 [13]

Core Insights - NewAmsterdam Pharma's obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's disease biomarker, in both the full analysis set and in ApoE4 carriers, indicating its potential as a novel approach to Alzheimer's prevention [1][3][13] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4][5] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2][15] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][16] - The company aims to address unmet needs in populations where current therapies are inadequate or poorly tolerated [16] - Obicetrapib is being evaluated in multiple clinical trials, including the pivotal Phase 3 BROADWAY trial, which assesses its efficacy and safety in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10][15] Clinical Trial Insights - The BROADWAY trial included 2,530 patients and was designed to evaluate the LDL-C lowering efficacy of obicetrapib [2][10] - A prespecified analysis of the trial assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][13] - The primary outcome measure was the absolute and percent change in p-tau217 over 12 months, with significant reductions observed [3][13] Biomarker Analysis - Statistically significant reductions in p-tau217 levels were observed in both the full analysis set and ApoE4 carriers, with p-values of 0.0019 and 0.0215, respectively [1][3][13] - Additional favorable trends were noted across other biomarkers, including NFL, GFAP, and p-tau181 [3][4][6] - The analysis highlights the potential of obicetrapib to influence Alzheimer's disease risk through lipid modulation, particularly in high-risk ApoE4 carriers [7][13] Future Directions - NewAmsterdam plans to discuss the results with regulatory authorities to determine potential next steps for obicetrapib [7][18] - The company is also exploring the commercialization rights of obicetrapib in Europe, which have been granted to the Menarini Group [15][16]

Core Insights - NewAmsterdam Pharma is set to present full data from the Alzheimer's Disease biomarker analyses in the BROADWAY clinical trial at the Alzheimer's Association International Conference on July 30, 2025 [1][2] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has observed statistically significant LDL-lowering effects in multiple Phase 2 trials, with a side effect profile similar to that of placebo [5] - NewAmsterdam commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, enrolling over 9,500 patients [5] Upcoming Events - The presentation titled "Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular Disease" will take place on July 30, 2025, at 8:21 AM ET [2] - A live webcast and conference call will be hosted by NewAmsterdam at 10:00 AM ET on the same day to review the full AD biomarker data [2][3]

Company Performance - Akebia Therapeutics reported quarterly earnings of $0.03 per share, exceeding the Zacks Consensus Estimate of a loss of $0.03 per share, and showing improvement from a loss of $0.09 per share a year ago, resulting in an earnings surprise of 200% [1] - The company posted revenues of $57.34 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 26.83%, compared to year-ago revenues of $32.61 million [2] - Over the last four quarters, Akebia has surpassed consensus EPS estimates two times and topped consensus revenue estimates twice [2] Stock Performance - Akebia Therapeutics shares have increased approximately 29.5% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.04 on revenues of $44.05 million, and for the current fiscal year, it is -$0.12 on revenues of $192.75 million [7] Industry Outlook - The Medical - Drugs industry, to which Akebia belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Core Insights - NewAmsterdam Pharma has appointed Adele Gulfo as an independent director to its Board of Directors, bringing over 30 years of experience in the healthcare industry [1][2][4] - The company is preparing for the potential launch of obicetrapib, an oral, non-statin medicine aimed at lowering LDL-C for patients at risk of cardiovascular disease [2][5] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for cardiometabolic diseases, specifically targeting patients with elevated LDL-C who do not respond well to existing treatments [5] - The company is investigating obicetrapib as a cholesterol ester transfer protein (CETP) inhibitor, which is being tested in multiple Phase 3 trials [5] Leadership and Experience - Adele Gulfo has a strong background in commercial leadership, having previously held executive roles at Sumitomo Pharma America, Sumitovant Biopharma, and Pfizer, where she contributed to the launch of major brands like LIPITOR® and CRESTOR® [2][3] - Her expertise in global strategy and operations is expected to be crucial for NewAmsterdam as it finalizes its commercial strategy and prepares for its first product launch [2][4] Clinical Development - NewAmsterdam has reported positive outcomes from its three pivotal Phase 3 clinical trials, indicating progress in its development efforts [4]

Core Insights - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][3] - The company aims to address the unmet need for safe and well-tolerated LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Company Overview - NewAmsterdam Pharma is investigating obicetrapib, a low-dose, once-daily CETP inhibitor, in multiple phase 3 trials [3] - The therapy is being studied both as a standalone treatment and in combination with ezetimibe, intended to complement statin therapy for patients with elevated LDL-C [3] Upcoming Events - Ian Somaiya, the Chief Financial Officer, will participate in a virtual fireside chat at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025 [1] - A live webcast of the event will be available on the company's investor relations website, with an archived replay to follow [2]

Group 1 - NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) has a strong late-stage cardiovascular pipeline in the biotech sector, which remains relatively unnoticed in the market [1] - The current market focus is primarily on GLP-1s and their potential impacts, indicating a competitive landscape in the biotech industry [1] - The company is positioned in a high-growth sector that is expected to experience exponential expansion, highlighting its potential for substantial returns through innovation [1]