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Royalty Pharma Acquires Royalty Interest in Nuvalent's Neladalkib and Zidesamtinib for Up to $315 Million
Globenewswire· 2025-12-16 12:15
NEW YORK, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it has acquired a pre-existing royalty interest in Nuvalent’s neladalkib and zidesamtinib from an undisclosed third party for up to $315 million. Neladalkib and zidesamtinib are next-generation tyrosine kinase inhibitors (TKIs). Neladalkib is in development for patients with ALK mutation-positive non-small cell lung cancer (NSCLC) and zidesamtinib is in development for ROS1 mutation-positive NSCLC. Both therap ...
Is Alnylam Entering A Corrective Phase After A Strong Run?
Benzinga· 2025-12-16 12:04
Alnylam (NASDAQ:ALNY) has corrected by roughly 13% over the past couple of weeks. To understand why this pullback is unfolding now, it is important to examine the stock's structure through the lens of the Adhishthana principles and assess where it stands within its broader cycle.Alnylam's Weekly StructureOn the weekly charts, Alnylam is currently in Phase 11 of its 18-phase Adhishthana cycle. Back in July, when the stock was still in Phase 10, we published a cautious commentary titled "Alnylam Pharma Stock ...
Monte Rosa Therapeutics Announces Compelling Clinical Activity of MRT-2359 in Combination with Enzalutamide in Heavily Pretreated Metastatic Castration-Resistant Prostate Cancer Patients with Androgen Receptor Mutations
Globenewswire· 2025-12-16 12:00
In mCRPC patients with androgen receptor (AR) mutations, treatment with MRT-2359 in combination with enzalutamide led to a 100% PSA response rate (4 of 4 patients) and a 100% disease control rate, including 2 patients with RECIST responses and 2 with stable disease Combination of MRT-2359 and enzalutamide was generally well-tolerated with primarily Grade 1-2 adverse events Company plans to initiate a new, signal-confirming Phase 2 study of MRT-2359 targeting AR mutant and AR signaling-dependent patients i ...
Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)
Globenewswire· 2025-12-16 12:00
Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, ...
大学校长对话企业家:大科学时代如何回应“钱学森之问”?
高校是科技研究的主力军,创新人才培养和科技成果转化的主阵地。 中国工程院院士、华南理工大学校长唐洪武表示,工业革命以来的历史就是一个持续的科技创新、升级、再创新、再升级的循 环过程。强国崛起的历程,就是抓住工业革命的机遇,快速提高生产力的过程。 正如经济学家熊彼特"创新理论"所揭示的,推动经济繁荣的关键力量在于一波强大创新集群的出现。大学与区域之间的互动融 合,是这一创新集群得以孕育并发挥效能的现实土壤。 唐洪武介绍,围绕国家重大战略方向与产业升级关键领域,华南理工大学打造了省部级以上平台291个,国家级平台30个,构筑 技术攻关的"硬核支撑";在大湾区部署13家高能级创新平台,各平台累计孵化企业超430家。他认为,高校不仅要做知识的"供 应商",更应是与企业并肩的"合伙人";企业也不仅是使用成果的"用户",更应是前沿问题的"出题人"和协同创新的"投资人"。 中国科学院院士、厦门大学党委书记张荣表示,近年来厦门大学加快布局大科学计划、大科学平台、大科学装置,完善基础研 究、应用研究、成果转化为一体的全链条协同发展机制,形成"三型四抓"实践(即联盟型、俱乐部型、开放型校企合作关系, 抓队伍、抓创新、抓转化、抓生 ...
QIAGEN N.V. (NYSE:QGEN) Stock Analysis: A Closer Look at Growth Potential and Financial Health
Financial Modeling Prep· 2025-12-16 02:00
Core Insights - QIAGEN N.V. is a leading provider of sample and assay technologies for molecular diagnostics and research, competing with companies like Thermo Fisher Scientific and Illumina [1] Performance Summary - Over the past 30 days, QIAGEN's stock has gained approximately 2.62%, but it experienced a decline of about 3.53% in the last 10 days, which may present a buying opportunity for investors [2][6] - The stock has a projected growth potential of 21.45%, indicating substantial appreciation from current levels [3][6] Financial Health - QIAGEN has a robust financial health, evidenced by a Piotroski Score of 8, reflecting solid profitability, liquidity, and operational efficiency [4][6] Analyst Outlook - Analysts have set a target price of $55 for QIAGEN, indicating significant upside potential from its current trading price, which reflects confidence in the stock's ability to reach higher valuations [5]
Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease
Businesswire· 2025-12-16 00:30
Core Viewpoint - Aldeyra Therapeutics, Inc. announced that the FDA has extended the PDUFA target action date for the reproxalap NDA for dry eye disease treatment to March 16, 2026 [1] Company Summary - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated diseases [1] Regulatory Update - The FDA's extension of the PDUFA target action date indicates a delay in the review process for reproxalap [1]
Radiopharm Theranostics (NasdaqCM:RADX) Update / Briefing Transcript
2025-12-16 00:02
Summary of Radiopharm Theranostics (NasdaqCM:RADX) Update / Briefing December 15, 2025 Company Overview - **Company**: Radiopharm Theranostics - **Ticker**: RADX - **Focus**: Development of imaging agents for brain metastases, specifically RAD-101 targeting fatty acid synthase Key Industry Insights - **Target Market**: Brain metastases primarily from lung cancer, breast cancer, and melanoma, which account for approximately 90% of cases [3][4] - **Current Treatment Challenges**: Difficulty in differentiating between tumor recurrence and treatment-related effects post-stereotactic radiosurgery (SRS) [4][11] - **Unmet Medical Need**: High demand for effective imaging solutions to accurately assess brain metastases and guide treatment decisions [11][19] Core Findings and Data - **RAD-101 Performance**: Preclinical data shows RAD-101 has superior uptake and tumor-to-brain ratios compared to traditional imaging agents like 18F FTG in various cancer models [2] - **Phase IIB Study**: Currently recruiting 30 patients in the U.S. to evaluate RAD-101's effectiveness in patients with suspected brain metastases post-SRS [4][5] - **Survival Correlation**: Patients with a standardized uptake value (SUV) greater than 2 showed significantly shorter overall survival, indicating the potential prognostic value of RAD-101 [6][8] - **Market Potential**: Estimated market size of $500 million in the U.S. for RAD-101, with a projected price of $4,800-$5,000 per dose [46][56] Competitive Landscape - **Lack of Competition**: Currently, no other imaging agents specifically targeting brain metastases are in clinical development, providing RAD-101 a unique market position [49][50] - **Differentiation from Other Agents**: RAD-101 targets fatty acid metabolism, while competitors focus on amino acid metabolism, addressing different patient populations [48][50] Future Plans - **Phase III Study**: Anticipated to include around 150 patients, focusing on sensitivity and specificity as primary endpoints [40][41] - **Longitudinal Studies**: Plans to conduct longitudinal scans to establish a truth standard for imaging efficacy [77] - **Potential for Therapeutic Version**: Exploration of developing a therapeutic isotope version of RAD-101 is underway [64] Additional Considerations - **Combination with MRI**: Initial strategy involves using RAD-101 in conjunction with MRI to enhance diagnostic accuracy [45][68] - **Patient Management Improvement**: Aim to enable earlier diagnosis and treatment of tumor recurrence, potentially improving patient outcomes [54][56] - **Safety Concerns**: Emphasis on the importance of accurate imaging to avoid unnecessary SRS procedures, which carry risks of side effects [65][67] Conclusion Radiopharm Theranostics is positioned to address a significant unmet need in the imaging of brain metastases with RAD-101, showing promising preclinical results and a clear path towards clinical development. The company is focused on establishing its market presence while ensuring patient safety and improving treatment outcomes through innovative imaging solutions.
Argenx SE (NASDAQ:ARGX) Faces Setback in Phase 3 Thyroid Eye Disease Studies
Financial Modeling Prep· 2025-12-16 00:00
Core Insights - Argenx SE has discontinued its Phase 3 UplighTED studies for efgartigimod SC in adults with moderate to severe thyroid eye disease due to futility, as advised by an Independent Data Monitoring Committee [1][2] - The company plans to conduct a comprehensive analysis of the data post-study closure to inform future research in thyroid eye disease [2] - Despite this setback, Argenx remains committed to advancing its portfolio of novel antibody-based medicines and exploring therapies for serious autoimmune conditions [3] Financial Overview - Argenx's stock has experienced fluctuations, with a recent price target set at $1,248 by Stifel Nicolaus, indicating a potential increase of approximately 40.26% from the current price of $849.52 [4] - The stock has seen a decrease of about 3.24% or $28.43 recently, with a trading range between $827.52 and $853.96 during the day [4] - Over the past year, the stock reached a high of $934.62 and a low of $510.06, with a market capitalization of approximately $51.96 billion [5]
Cogent Biosciences: Time For A Pause (NASDAQ:COGT)
Seeking Alpha· 2025-12-15 23:11
Live Chat on The Biotech Forum sees frequent discussion of specific covered call trades. To see what covered call trades I am currently executing along with a model portfolio of attractive biotech stocks, just initiate your free trial into The Biotech Forum by clicking HERE .Bret Jensen has over 13 years as a market analyst, helping investors find big winners in the biotech sector. Bret specializes in high beta sectors with potentially large investor returns.Bret leads the investing group The Biotech Forum, ...