Core Viewpoint - Vanda Pharmaceuticals (VNDA.US) stock price increased by over 25.46% following the FDA approval of its new drug Nereus, which is intended for the prevention of vomiting induced by motion [1][2]. Group 1: FDA Approval and Drug Details - The FDA approval of Nereus is based on results from three clinical studies that compared the drug group with a placebo group to assess the occurrence of vomiting [2]. - Data from the trials indicated that Nereus achieved a "significant reduction" in vomiting events and demonstrated "good safety characteristics" in short-term, acute use scenarios [2]. Group 2: Market Implications - The approval of Nereus is expected to provide a new commercialization growth point for the company and further enrich its product portfolio in the central nervous system and related indications [2].

Core Viewpoint - Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ONS-5010/LYTENAVA™, indicating that the application for treating wet age-related macular degeneration (wAMD) cannot be approved in its current form [2][3]. Group 1: FDA Response and Company Position - The FDA's CRL stated that the additional data provided in the BLA did not alter the previous review conclusion, despite a well-controlled study demonstrating efficacy. The FDA recommended submitting confirmatory evidence to support the application but did not specify what type of evidence would be acceptable [3][8]. - The CEO of Outlook Therapeutics expressed disappointment with the FDA's decision but reaffirmed the company's commitment to obtaining approval in the U.S. and emphasized the clinical need and commercial potential for a specifically formulated bevacizumab product for intravitreal use [6][11]. Group 2: Clinical Trial Data - The resubmission of the BLA for ONS-5010 was based on the complete dataset from the NORSE clinical trial program, which included successful results from the NORSE TWO pivotal trial and additional safety and efficacy data from other NORSE trials [8]. - The NORSE TWO trial demonstrated significant efficacy, and the company believes that the complete dataset supports the BLA for approval in the U.S. [8]. Group 3: Market Expansion and Product Launch - LYTENAVA™ has received marketing authorization in the EU and the UK for treating wAMD, with plans to launch in Germany and the UK by June 2025 [11][19]. - The product is positioned as a cost-effective, first-line treatment option for healthcare professionals and patients, with potential gross peak sales exceeding $300 million across Germany and the UK, representing over 50% of the total opportunity in Western Europe [19][20].

Core Viewpoint - Axsome Therapeutics has received priority review designation from the FDA for its AXS-05 application aimed at treating agitation in Alzheimer's disease, with a target action date set for April 30, 2026, leading to a significant stock price increase of 22.75% and a market capitalization of $9.2 billion [1][3]. Group 1: Company Overview - Axsome Therapeutics (NASDAQ: AXSM) is a biopharmaceutical company focused on treating central nervous system (CNS) diseases, with AXS-05 being a key product under review for Alzheimer's agitation [3][5]. - The company was founded by Herriot Tabuteau, who has a background in both medicine and finance, allowing for a unique perspective on project evaluation [6][8]. - Axsome's growth strategy targets the significant unmet medical needs in CNS disorders, with an estimated 150 million people in the U.S. affected by conditions like depression and Alzheimer's [9]. Group 2: Product Development and Financials - AXS-05 is a novel oral investigational drug combining dextromethorphan and bupropion, currently in development for treating agitation in Alzheimer's disease and smoking cessation [5]. - The company has not yet achieved profitability, reporting a net loss of $247 million for the 12 months ending June 2025, but has generated $495 million in revenue, reflecting a 70% year-over-year increase [10]. - The company aims to push five new drugs to approval by 2028, with peak sales potential for its existing product portfolio estimated at $16.5 billion [10]. Group 3: Key Products and Market Position - Auvelity, Axsome's flagship antidepressant, shows rapid efficacy within one week, contrasting with traditional antidepressants that take 6-8 weeks, leading to a stock surge of 65% post-approval [11]. - The company executed a strategic acquisition of Sunosi for $53 million, later recouping $66 million by transferring rights in Europe and the Middle East, showcasing effective financial maneuvering [11]. - The upcoming AXS-05 approval could fill a significant market gap for treating agitation in Alzheimer's, addressing the limitations of current antipsychotic medications [11].

周三，Corcep医疗(CORT.US)股价暴跌超50.42%，收于34.80美元。 Corcept Therapeutics 表示已收到美国食品药品监督管理局(FDA)发出的完整回应函，其新药申请未获批准。该申请旨在寻求批准口服药物 Relacorilant用于治疗因皮质醇增多症(高皮质醇血症)引发的继发性高血压。 Corcept Therapeutics围绕库欣综合征开展了多项临床试验。 公司称，FDA在回应函中确认，Corcept的关键性GRACE临床试验达成主要终点，且GRADIENT试验数据具有验证性意义；但监管机构认为， 现有资料仍不足以支持对该疗法作出有利的收益—风险评估，因而要求补充更多有效性证据。 Relacorilant为一种选择性的糖皮质激素受体拮抗剂，关键临床GRACE中达到降血压主要终点，63%的患者达到响应标准。 患者血糖控制获得改善。 患者生活质量、认知评估获得显著改善。 对此，Corcept首席执行官Joseph K. Belanoff表示，公司"对这一结果感到意外和失望"，并称将"尽快与FDA会面，讨论并确定最佳的后续推 进路径"。 资料显示，relacorilant为一种口 ...

Core Viewpoint - The article presents an optimistic outlook for the U.S. economy in 2026, driven by tax cuts and potential government spending increases, despite concerns about tariffs and inflation [3][10]. Economic Growth Predictions - U.S. Treasury Secretary Scott Bessen predicts accelerated economic growth starting in 2026, supported by the tax cut law "One Big Beautiful Bill Act" (BBB), which is expected to provide a stimulus equivalent to 0.3% of GDP [3][4]. - The Federal Reserve Bank of Philadelphia's survey indicates a potential slowdown in economic growth to 1.8% in 2026 due to policy confusion and tariff pressures [3]. - The annualized GDP growth rate for Q3 2025 was reported at 4.3%, indicating a healthy economic environment prior to potential disruptions from government shutdowns [3]. Government Spending and Taxation - The Hutchins Center estimates that government spending restoration could provide an additional GDP stimulus of 0.6% alongside the tax refunds [4]. - A significant reduction in IRS budget could lead to increased tax evasion, potentially impacting GDP by 0.25% or more [4]. Tariff Implications - The Congressional Budget Office forecasts tariff revenues to reach $215 billion by 2026, which could indirectly affect consumer purchasing power through higher prices [6]. - The Supreme Court's potential ruling on tariffs could necessitate refunds for companies that paid illegal tariffs, impacting GDP by approximately 0.5% [6][7]. Monetary Policy and Market Outlook - The Federal Reserve has lowered interest rates to a range of 3.5%-3.75%, the lowest since 2022, indicating a shift towards more accommodative monetary policy [7]. - Predictions suggest that the S&P 500 index could rise by 9% in 2026, which would enhance household wealth and stimulate consumer spending [9]. Global Economic Context - Analysts predict that 2026 could witness strong international economic growth, driven by fiscal expansions in Germany and consumer stimulus reforms in China [10]. - Current Brent crude oil prices are at $61 per barrel, near a four-year low, which could further support economic growth [10]. Labor Market and Inflation Concerns - Despite a tight labor market, strong wage growth suggests resilience rather than weakness, although low hiring numbers remain a concern [10]. - The article warns that combining fiscal and monetary stimulus could reignite concerns over government debt, potentially undermining the credibility of the Federal Reserve's inflation target [10].

Core Viewpoint - The article presents a series of predictions for 2026, covering various global political, economic, and technological trends, highlighting uncertainties and potential developments in multiple sectors. Trade and Tariffs - Trump's tariff policies are unlikely to raise average tariff levels above current rates due to complexities and market reactions, including stock market declines and consumer price increases [4][5]. Geopolitical Developments - Ukraine is not expected to concede the Donbas region in peace negotiations, as military and political factors make such a concession too risky for President Zelensky [5]. - The U.S. Republican Party is predicted to lose control of the House in the upcoming midterm elections, allowing the Democratic Party to block Trump's agenda [5]. Technology and Investment - The artificial intelligence bubble is expected to burst by 2026, with significant losses anticipated for venture capital and private equity, particularly affecting smaller companies [5]. - Home robots are anticipated to become available, with a startup accepting pre-orders for a humanoid robot priced at $20,000, expected to be delivered by 2026 [11]. Currency and Economic Trends - The Chinese yuan is not expected to appreciate significantly, with a projected exchange rate of 7.01 against the dollar, and a one-year forward rate of 6.89 [7]. - Africa's economic growth is expected to slightly surpass Asia's, driven by structural reforms and favorable fiscal policies, despite ongoing challenges [12]. Financial Markets - Gold prices are projected to rise, potentially exceeding $5,000 per ounce, driven by central bank purchases and as a hedge against economic uncertainties [12]. - The likelihood of a significant increase in private credit defaults is high, as companies struggle with rising interest rates, leading to potential bankruptcies [10]. Political Landscape - France is not expected to hold early elections, as political focus shifts towards the 2027 presidential elections [6]. - The leadership of the UK Labour Party may face challenges following poor performance in local elections, with potential for internal strife [9].

对一些人来说，家才是新年派对所在的地方。图片来源：Lexey Swall /《纽约时报》 艾莉森·克鲁格（Alyson Krueger） 阿比盖尔·塔夫茨（Abigail Tufts）迫不及待地盼着跨年夜的到来。 这位36岁的纽约市民、公关公司创始人说，过去几年，她都会"穿上亮片礼服、化好妆、穿上舞 会长裙"去参加派对。 但今年——无论在职业还是个人生活上都格外艰难的一年——她决定彻底跳过所有庆祝活动，独 自一人去电影院观看《怪奇物语》第五季的大结局。 When the Best New Year's Plans Are No New Year's Plans 许多人选择避开喧嚣——这要么是他们由来已久的传统，要么是因为今年有了不同的心态。 但今年她的感觉只有一个字："唉。"她进一步解释道："最近的新闻让我有点心力交瘁，而 且……每年的计划从来就没按预期实现过，差得可远了。" 因此，她对2026年的唯一计划就是"顺其自然"——从跨年夜就开始践行：她打算和伴侣一起待 在纽约家中，开一瓶好酒，点个披萨。 她不打算回顾过去一年，也不打算立新年决心。"我简直等不及要关掉手机了，"她说。 一 直 以 来 ， 总 有 一 ...

Group 1 - Warner Bros. Discovery (WBD.US) plans to reject Paramount's (PSKY.US) revised acquisition offer, as the board has not made a final decision yet [1][3] - Paramount has not increased its offer, which Warner Bros. previously deemed inferior to Netflix's (NFLX.US) proposal [3][4] - Paramount's latest offer includes a cash bid of $30 per share and a personal guarantee of $40.4 billion in equity financing from Oracle founder Larry Ellison [3] Group 2 - Warner Bros. board is waiting for Paramount to improve the financial terms of its offer, with shareholders expecting more funding from Paramount [4] - Concerns exist that a deal with Paramount could restrict Warner Bros. from managing its debt without Ellison's approval, and Paramount has not guaranteed to cover the breakup fee owed to Netflix [4] - Warner Bros. argues that Netflix's offer is superior for various reasons, including Paramount's potential debt burden and plans for further job cuts [4]

Core Viewpoint - The majority of participants believe that if inflation gradually decreases as expected, it may be appropriate to further cut interest rates, with most supporting a rate cut in December [1][4][5] Group 1: Interest Rate Decisions - Most participants support a rate cut in December, although a few indicated they might have supported holding rates steady after careful consideration [4][7] - Some decision-makers suggest that a pause in rate cuts for some time could allow for assessment of the recent neutral policy stance's impact on the labor market and economic activity [4][6] - The minutes reveal significant internal divisions within the Federal Reserve regarding the decision to cut rates, with the largest dissent seen in 37 years [5][9] Group 2: Economic Indicators - Participants noted that inflation has risen since the beginning of the year and remains at a high level, while economic activity is expanding at a moderate pace [6][9] - There is an observed slowdown in job growth, with the unemployment rate slightly increasing as of September, leading to increased downside risks in employment [6][9] Group 3: Inflation and Employment Risks - Most participants believe that cutting rates could help prevent deterioration in the labor market, while some express concerns about entrenched inflation risks [8][9] - There is a notable division among decision-makers regarding which poses a greater threat to the economy: inflation or unemployment, with many believing that a shift to a more neutral policy stance could help prevent severe labor market deterioration [9] Group 4: Reserve Management - The minutes confirm that reserve balances have fallen to adequate levels, prompting the Federal Reserve to begin purchasing short-term government bonds to manage reserves [10]

援引知情人士透露的消息报道称，"AI芯片超级霸主"兼全球最高市值公司英伟达(NVDA.US)在此前豪掷200亿美元拿下Groq核心团队后不久，正在就以 20亿美元至30亿美元收购总部位于以色列的人工智能领军者AI21 Labs进行深入收购谈判。 据了解，以色列AI初创公司AI21 Labs聚焦于开发大语言模型(即LLM)，并使企业能够快速构建类似ChatGPT的定制化企业级生成式AI应用， 在企业AI生态具备重要地位。该公司于2017年由Amnon Shashua共同创立，Shashua同时也是自动驾驶领域主导者Mobileye(MBLY.US)的联 合创始人兼首席执行官。 据媒体报道称，这家AI初创公司在2023年的一轮由英伟达(NVDA.US)和谷歌(GOOGL.US)领投的融资之后，经历最近一次的融资后的整体估值 约为14亿美元。该公司约有200名员工，其中许多人拥有高等理工科学位并在AI应用开发方面具备非常丰富的经验。这意味着英伟达可能更看 重AI21顶尖员工们的综合AI技能组合，而不仅仅是该公司的技术本身。 黄仁勋越来越青睐以色列科技公司 过去几年里，英伟达一直在积极收购总部位于以色列的那些最顶级科 ...