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300亿美元天价收购告吹!默沙东与Revolution因价格分歧中止谈判
Zhi Tong Cai Jing· 2026-01-26 01:03
据悉,Revolution Medicines正在研发的泛RAS抑制剂RMC-6236(通用名为Daraxonrasib)是该公司拥有的 关键资产。Daraxonrasib这款前沿药物是一种口服靶向药、一种直接作用的RAS(ON)多选择性抑制剂, 用于治疗由RAS基因突变驱动的癌症。它直接作用于处于激活状态的RAS蛋白,阻断RAS与下游信号蛋 白的结合,从而抑制RAS信号通路的持续激活,减缓肿瘤细胞的生长和增殖。Daraxonrasib靶向常见的 致癌性RAS突变,包括G12X、G13X和Q61X突变,这些突变是胰腺导管腺癌(PDAC)、非小细胞肺癌 (NSCLC)和结直肠癌(CRC)等主要癌种的重要驱动因素。 目前,Daraxonrasib正在四项全球3期临床试验中接受评估,其中包括三项针对胰腺导管腺癌(PDAC)的 研究,以及一项针对局部晚期或转移性RAS突变非小细胞肺癌(NSCLC)的研究。关键研究结果预计将于 今年夏季公布。 Revolution Medicines在去年12月宣布,RASolute304临床试验已完成首例患者入组。RASolute304是一项 全球性、开放标签、3期临床试验,旨在评估 ...
Ascletis Announces First Participants Dosed in a 13-week U.S. Phase II Study with ASC30, an Oral Small Molecule GLP-1R Agonist for the Treatment of Diabetes
Prnewswire· 2026-01-26 00:10
Core Insights - Ascletis Pharma Inc. is advancing its investigational drug ASC30, a GLP-1 receptor agonist, into a Phase II study for type 2 diabetes, with topline data expected in Q3 2026 [2][5] Group 1: ASC30 Development - ASC30 has shown a placebo-adjusted weight loss of up to 7.7% in a completed 13-week Phase II study for obesity, demonstrating better gastrointestinal tolerability compared to other treatments [1][3] - The Phase II study for diabetes will evaluate ASC30's efficacy, safety, and tolerability, focusing on changes in HbA1c and body weight among approximately 100 participants [5][6] - ASC30 is designed for once-daily oral administration and has been developed in-house by Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist [4][6] Group 2: Clinical Study Details - The obesity Phase II study involved 125 participants and reported a treatment discontinuation rate due to adverse events of 4.8% [3] - The study for diabetes is randomized, double-blind, and placebo-controlled, with participants assigned to different dosages of ASC30 [5] - The primary endpoint of the diabetes study is the mean change in HbA1c from baseline, with secondary endpoints including fasting blood glucose and body weight changes [5]
FDA Accepts LEQEMBI® IQLIK™ (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review
Globenewswire· 2026-01-25 23:30
Core Viewpoint - The FDA has accepted for review Eisai's Supplemental Biologics License Application for LEQEMBI IQLIK, which, if approved, would be the first anti-amyloid treatment allowing at-home injections for Alzheimer's disease, with a decision expected by May 24, 2026 [2][3]. Group 1: Product Details - LEQEMBI IQLIK is a subcutaneous autoinjector for lecanemab, intended for weekly starting doses in treating early Alzheimer's disease [2][3]. - The proposed dosing regimen involves two 250 mg injections, allowing patients to choose between subcutaneous or intravenous administration throughout treatment [3][4]. - The injection time for each 250 mg dose is approximately 15 seconds, potentially reducing healthcare resource utilization compared to intravenous dosing [3]. Group 2: Clinical Data and Safety - Clinical data supporting the sBLA indicates that the 500 mg subcutaneous administration achieves equivalent exposure to the bi-weekly intravenous dosing, with similar clinical and biomarker benefits [4]. - The safety profile of subcutaneous administration is comparable to intravenous administration, with less than 2% incidence of systemic injection or infusion-related reactions [4]. - LEQEMBI is currently approved in 53 countries and regions, with ongoing regulatory reviews in 7 additional countries [6][30]. Group 3: Mechanism of Action - LEQEMBI targets both protofibrils and amyloid plaques, which are critical in the neurotoxic process of Alzheimer's disease, potentially impacting tau pathology [5][29]. - Protofibrils are identified as the most toxic species contributing to cognitive decline in Alzheimer's, and reducing them may mitigate neuronal damage [7]. Group 4: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and promoting the product [6][33]. - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development and commercialization of Alzheimer's treatments [34]. Group 5: Market Position - The approval of LEQEMBI IQLIK would enhance treatment options for Alzheimer's patients, particularly in the early stages of the disease, and could streamline the treatment process [2][3][4]. - The product's introduction aligns with the growing demand for innovative therapies in the Alzheimer's treatment landscape, addressing significant unmet medical needs [35][38].
Merck No Longer in Talks to Buy Revolution Medicines
WSJ· 2026-01-25 19:30
Group 1 - The drugmaker is in discussions to acquire RevMed, a cancer-drug biotech [1] - The potential deal could value RevMed at approximately $30 billion [1]
Hecla Mining, Moderna, And Micron Are Among the Top 10 Large-Cap Gainers Last Week (Jan. 19-Jan. 23): Are the Others in Your Portfolio? - First Majestic Silver (NYSE:AG), Coeur Mining (NYSE:CDE), Hecl
Benzinga· 2026-01-25 14:01
These ten large-cap stocks were top performers last week. Are they a part of your portfolio?Hecla Mining Company (NYSE:HL) gained 29.31% this week. Precious metal stocks rose amid ongoing geopolitical tensions as the US dollar weakened. The commodity may be climbing due to investor expectations that the Fed will cut rates.First Majestic Silver Corp. (NYSE:AG) increased 26.57% this week.Venture Global, Inc. (NYSE:VG) jumped 21.6% this week. The company said the ICC issued a final arbitration award denying Re ...
VISTAGEN CLASS ACTION ALERT: Bragar Eagel & Squire, P.C. Reminds Vistagen Therapeutics, Inc. Stockholders of the Upcoming Lead Plaintiff Deadline and Encourages Investors to Contact the Firm
Globenewswire· 2026-01-24 15:28
Core Viewpoint - A class action lawsuit has been filed against Vistagen Therapeutics, Inc. for allegedly providing misleading information regarding its Phase 3 PALISADE-3 trial of fasedienol, leading to significant investor losses [2][8]. Group 1: Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Vistagen common stock between April 1, 2024, and December 16, 2025, inclusive [2]. - Investors have until March 16, 2026, to apply to the Court to be appointed as lead plaintiff in the lawsuit [2]. Group 2: Allegations - The complaint alleges that Vistagen made overwhelmingly positive statements while concealing material adverse facts about the Phase 3 PALISADE-3 trial [8]. - On December 17, 2025, Vistagen announced that the PALISADE-3 study did not show a statistically significant improvement on its primary endpoint, leading to a dramatic stock price decline [8]. Group 3: Financial Impact - Following the announcement of the trial results, Vistagen's stock price fell from $4.36 per share on December 16, 2025, to $0.86 per share on December 17, 2025, representing a decline of more than 80% [8].
Curative Biotech announces Canadian patent allowance
Yahoo Finance· 2026-01-24 13:50
Core Insights - Curative Biotech (CUBT) has received a Notice of Allowance for Canadian Patent Application No. 3,151,011, which focuses on a "Druggable Target to Treat Retinal Degeneration" [1] - The company holds an exclusive worldwide license for this technology through a patent license agreement with the National Eye Institute, part of the National Institutes of Health [1] - The patent includes 22 allowed claims, particularly concerning topical ocular delivery methods relevant to metformin-based formulations, aligning with the company's intended administration route [1] - The formal issuance of the patent is anticipated in the coming months [1]
UPCOMING DEADLINE: Faruqi & Faruqi, LLP Notifies Vistagen (VTGN) Investors of the Pending Class Action Lawsuit
Globenewswire· 2026-01-24 13:42
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered In Vistagen To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Vistagen between April 1, 2024 and December 16, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Jan. 24, 2026 (GLOBE NEWSWIRE) -- Faruqi & Far ...
SHAREHOLDER ALERT: Faruqi & Faruqi, LLP Notifies Vistagen (VTGN) Investors of the Pending Class Action Lawsuit
TMX Newsfile· 2026-01-24 12:44
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Vistagen Therapeutics, Inc. due to alleged violations of federal securities laws related to misleading statements about its Phase 3 PALISADE-3 trial of fasedienol for social anxiety disorder [2][5]. Group 1: Legal Investigation - The law firm is encouraging investors who purchased Vistagen securities between April 1, 2024, and December 16, 2025, to discuss their legal rights [1]. - A federal securities class action has been filed against Vistagen, with a deadline of March 16, 2026, for investors to seek the role of lead plaintiff [2][7]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [4]. Group 2: Trial Results and Stock Impact - On December 17, 2025, Vistagen announced that its PALISADE-3 study did not meet its primary efficacy endpoint, resulting in a significant stock decline of $3.50 or 80.27%, closing at $0.86 [6]. - The study failed to show statistically significant improvement in anxiety reduction compared to placebo, raising concerns about the company's disclosures [5][6]. Group 3: Call for Information - The firm is also seeking information from whistleblowers, former employees, and shareholders regarding Vistagen's conduct [8].
Axsome Therapeutics: A Conditional Buy Built On SG&A Discipline
Seeking Alpha· 2026-01-24 11:38
Core Viewpoint - The investor is focused on building a resilient, income-generating portfolio with a long-term growth mindset, emphasizing disciplined, fundamentals-driven investing and capital preservation while compounding returns over time [1]. Group 1: Investment Strategy - The investment approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities [1]. - The investor prioritizes capital preservation alongside the compounding of returns over time [1]. Group 2: Background - The investor is based in Dubai and originally from India, indicating a diverse geographical perspective in investment strategies [1].