Novo Nordisk US listed shares jumping in late trading after it secured FDA approval for a pill version of its weight loss. Jab Wegovy. The pill is expected to launch in the US in January.Let's get more from Bloomberg's pharma reporter, Amber Tong. Amber. Walk us through the significance of this.We've had, of course, the injection for quite some time. Why is a pill so important. Yeah.Oliver, This is really something that many people have been waiting for for a long time. As you said, Wegovy and Novo Nordisk ...

Core Viewpoint - The approval of the first oral GLP-1 weight loss medication, Wegovy, by the U.S. regulatory authorities marks the beginning of a new era in obesity treatment, with potential for further expansion in this category [1]. Group 1: Company Developments - Following the announcement, the stock of Novo Nordisk rose approximately 10% in after-hours trading, ultimately closing with a gain of 9.5% [2]. - The approval is a significant victory for Novo Nordisk, which has faced intense competition from Eli Lilly in the weight loss drug market, leading to pressure on its stock earlier in the year [3]. - Novo Nordisk plans to launch the new oral medication in early January at a cash price of $149 per month, with potential costs as low as $25 per month for insured patients [4]. Group 2: Clinical and Market Insights - The oral medication contains 25 mg of semaglutide, the same active ingredient found in the injectable versions of Wegovy and Ozempic, and is expected to provide significant weight loss results [4]. - Clinical trial results from the Oasis 4 study indicated that patients taking the 25 mg dose lost an average of approximately 16.6% of their body weight over 64 weeks, supporting the drug's efficacy [4]. - The FDA approval also allows the drug to be used for reducing the risk of major cardiovascular events in adults with obesity and diagnosed cardiovascular disease [4]. Group 3: Competitive Landscape - Analysts note that the approval of the GLP-1 weight loss pill is a much-needed win for Novo Nordisk amid challenges to maintain its market share in the incretin market [5]. - Earlier this year, Eli Lilly captured a significant market share with its injection drug Zepbound, which has been shown to be more effective than Novo Nordisk's Wegovy [6]. - The market for weight loss drugs is expected to grow significantly, with Goldman Sachs analysts projecting that by 2030, weight loss medications could account for 24% of the global weight loss drug market, approximately $22 billion [6].

Core Insights - Novo Nordisk's newly approved weight-loss pill, a version of Wegovy, is set to enter the U.S. self-pay market in early January, marking a significant development in the cash-paying consumer market for weight-loss treatments [1] Group 1 - The new oral treatment is expected to be highly effective, positioning it as a test case for the rapidly growing consumer market [1]

Core Insights - Healthcare and biotechnology stocks experienced significant movements in after-hours trading, with several companies showing strong gains despite limited news flow [1] Company Summaries - Novo Nordisk A/S (NVO) saw a notable increase of 9.48%, closing at $52.66, following FDA approval of its Wegovy pill, the first oral GLP-1 medicine for obesity in the U.S., which is also approved to reduce cardiovascular risks [2] - Neumora Therapeutics, Inc. (NMRA) advanced 16.02% to $2.10, indicating investor interest possibly driven by broader sector momentum or speculative trading, as there were no specific news updates [3] - BioRestorative Therapies, Inc. (BRTX) rose 6.90% to $1.24, with investors reacting to a prior announcement regarding an FDA Type B meeting to discuss a potential accelerated BLA pathway for its BRTX-100 program for chronic lumbar disc disease [4] - RenovoRx, Inc. (RNXT) added 4.44% to close at $0.94, with earlier news of an accepted abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026 contributing to investor interest [5] - IDEAYA Biosciences, Inc. (IDYA) gained 6.49% to $37.81, following the full enrollment of 435 patients in its Phase 2/3 trial for darovasertib, with expected data reporting in Q1 2026 [6] - Healthcare Triangle, Inc. (HCTI) climbed 6.72% to $1.43, with a recent announcement of an Advance Agreement for acquiring AI-powered customer experience firms, enhancing its position in global AI-driven solutions [7] - Alphatec Holdings, Inc. (ATEC) posted a modest gain of 2.80%, rising to $21.28, benefiting from ongoing investor confidence in the spine surgery provider [8]

美国FDA批准了诺和诺德的首款口服GLP-1减肥药，使其在与礼来的激烈竞争中抢得先机，公司股价盘后一度应声大涨10%。这款Wegovy的口服版本 将于明年1月初在美国上市，起始现金价为每月149美元。临床数据显示其可帮助患者减重高达16.6%，并能降低心血管风险。礼来的同类口服药预计在3 月获批。 抢在礼来之前，诺和诺德在美国的减肥药市场竞争中扳回一局。 12月22日周一，美国食品药品监督管理局（FDA）批准了丹麦制药巨头诺和诺德的首款GLP-1类口服减肥药。这款新药是其明星注射产品Wegovy的口 服版本，为数百万寻求更便捷治疗方案的肥胖症患者带来了新选择。 根据诺和诺德的声明，这款口服新药将于明年1月初在美国上市。公司披露了初步的定价策略， 起始剂量的现金支付价格为每月149美元。公司同时表 示，对于拥有保险的患者，在涵盖所有剂量的情况下，每月费用可能低至25美元。 更高剂量的定价以及更详细的保险覆盖和患者节省计划将在临近上 市时公布。 诺和诺德首席执行官Mike Doustdar在声明中表示："Wegovy口服药为患者提供了一个全新、便捷的治疗选择，可以帮助他们开始或继续他们的减重旅 程。"他强调，目前 ...

整理 | GLP1减重宝典内容团队 2025 年 12 月 22 日，司美格鲁肽注射液获中国国家药品监督管理局批准新增心血管适应症，用于降低已确诊心血管疾病且体重指数不 低于 27 的成人患者主要心血管不良事件风险，包括心血管死亡、非致死性心肌梗死和非致死性卒中。这一批准，标志着司美格鲁肽在 中国正式从单一减重治疗，拓展至心血管结局管理领域。 版权声明：所有「GLP1减重宝典」的原创文章，转载须联系授权，并在文首/文末注明来源、作者、微信ID，否则减重宝典将向其追究法律责 任。部分文章推送时未能与原作者或公众号平台取得联系。若涉及版权问题，敬请原作者联系我们。合作事宜，请添加微信：andyxu365 作为当前肥胖症规范化治疗体系中的重要手段之一，司美格鲁肽在体重管理和心血管风险控制方面展现出双重临床价值。临床研究显 示，约三分之一患者的体重降幅可超过 20%，同时主要不良心血管事件风险降低约 20%。目前，司美格鲁肽是唯一被证实同时具备明 确减重效果和降低主要心血管不良事件风险的减重药物。 | 161 | IXSS2500007 | 司美格鲁肽注射液 | 诺和诺德（中国）制药有限公 | 国药准字 | 2025 ...

整理 | GLP1减重宝典内容团队 2025年12月22日，诺和诺德宣布，其口服司美格鲁肽片剂Wegovy已获得美国食品药品监督管理局批准，用于减轻超重体重、长期维持减重效 果，并降低主要不良心血管事件发生风险。这一产品为每日一次、25毫克剂量，是全球首款获批用于体重管理的口服GLP-1受体激动剂疗法。 安全性方面，OASIS 4再次验证了司美格鲁肽已知的耐受性特征，与既往用于体重管理的临床结果一致，未出现新的安全信号。 这一批准节点，标志着减重药物竞争进入全新阶段。继注射剂型迅速放量后，口服方案首次在疗效、安全性与监管层面同时成立，意味着减重 治疗正在从阶段性干预，转向更接近慢病管理的长期用药模式。 受此消息影响，诺和诺德股价盘后大涨10%。 点击关注，追踪最新GLP-1资讯 ▍16.6%的数字背后：口服首次"对齐"注射疗效 此次获批的核心依据，来自OASIS临床试验项目与SELECT心血管结局研究数据。其中，OASIS 4试验成为决定性证据。 在该Ⅲb期试验中，纳入了307名肥胖或超重、且合并至少一种并发症的成年受试者。结果显示，每日坚持服用25毫克口服司美格鲁肽，64周后 平均减重比例达到16.6%，与 ...

Group 1: Market Overview - Obesity is a significant public health challenge in China, with approximately 180 million patients, the highest globally. Without intervention, the prevalence of overweight and obesity among adults is projected to reach 65.3% by 2030 [1] - The GLP-1 weight loss drug market is primarily dominated by Eli Lilly and Novo Nordisk, with a projected global market size of approximately $52.83 billion in 2024, reflecting a 46% year-on-year growth [4] - The demand for GLP-1 weight loss drugs has surged, with social media referring to them as "miracle drugs" due to their effectiveness in controlling blood sugar, delaying gastric emptying, and suppressing appetite [1] Group 2: Key Players and Products - Novo Nordisk's semaglutide holds the largest market share at 55%, with products Ozempic, Wegovy, and Rybelsus contributing a combined sales forecast of $29.296 billion in 2024 [5] - Eli Lilly's tirzepatide follows closely with a 31% market share, generating nearly $16.5 billion in revenue, approximately 36% of Eli Lilly's total revenue for 2024 [6] - Notable products expected to be among the top-selling drugs globally by 2026 include Mounjaro, Zepbound, and Wegovy, with projected sales of $25.8 billion, $19.7 billion, and $15.4 billion respectively [7][8] Group 3: Competitive Landscape - Both Eli Lilly and Novo Nordisk are intensifying their competition, with Novo Nordisk announcing clinical trial results for a higher dose of semaglutide that could elevate weight loss efficacy above 20% [9] - Eli Lilly is also advancing its oral GLP-1 drug Orforglipron, which is expected to be approved soon, showing a weight loss of approximately 12.4% over 48 weeks [10] - Other pharmaceutical companies, such as AstraZeneca and Roche, are entering the weight loss market, with AstraZeneca focusing on new mechanisms and Roche collaborating on long-acting insulin analogs [11][12] Group 4: Domestic Market Developments - Domestic companies are rapidly developing GLP-1 weight loss drugs, with ten companies currently applying for semaglutide injections, indicating a competitive landscape in China [14] - The expiration of semaglutide's core patent in March 2026 is seen as a significant opportunity for domestic firms to launch generic versions, potentially leading to a surge in market entries [16] - Innovative products like the dual receptor agonist developed by Innovent Biologics and the long-acting GLP-1 drugs from domestic companies are expected to reshape the market dynamics [17][18] Group 5: Future Trends - The global weight loss drug market is anticipated to shift towards lower prices and higher accessibility, with both Eli Lilly and Novo Nordisk announcing price reductions for their GLP-1 drugs [20] - The World Health Organization has recommended GLP-1 drugs as a long-term treatment for obesity, emphasizing the need for increased production and reduced costs to ensure accessibility [19] - The Chinese weight loss drug market is projected to grow from 260 million yuan in 2016 to 8.7 billion yuan by 2025, reaching 14.9 billion yuan by 2030, indicating a robust growth trajectory [25]

Market Overview - Major U.S. indexes closed higher, with the Dow Jones Industrial Average rising 0.47% to 48,362.68, the S&P 500 advancing 0.6% to 6,878.49, and the Nasdaq adding 0.5% to finish at 23,428.82 [1] Novo Nordisk - Novo Nordisk's stock saw a slight increase of 0.01%, closing at $48.10, with an intraday high of $48.22 and a low of $47.59; the stock surged nearly 9.5% in after-hours trading to $52.66 [2] - The FDA approved Novo Nordisk's Wegovy pill, the first oral GLP-1 therapy authorized in the U.S. for long-term weight management and cardiovascular risk reduction, based on the OASIS trial where patients lost an average of 16.6% of their body weight [3] Starfighters Space Inc. - Starfighters Space shares skyrocketed by 372.97%, closing at $31.50, with an intraday high of $31.50 and a low of $6.40; however, the stock plummeted 23.75% to $24.02 in after-hours trading [4] - The surge followed the company's IPO priced at $3.59, raising $40 million for hypersonic research and satellite launch operations, amid strong momentum in the space sector driven by defense contracts and investor interest [5] D-Wave Quantum Inc. - D-Wave Quantum's stock climbed 20.07%, closing at $32.19, with a high of $32.39 and a low of $27.62 [6] - The stock's increase was part of a late-December "Santa Rally," driven by retail investors focusing on high-beta quantum computing names, with D-Wave's shares jumping nearly 20% after announcing its Advantage2 system will feature at CES 2026 [7] Sidus Space Inc. - Sidus Space shares jumped 96.98%, closing at $2.28, with an intraday high of $2.59 and a low of $1.80; the stock dropped 39.2% in after-hours trading [8] - The surge was attributed to the company being selected as a contract awardee under the U.S. Missile Defense Agency's SHIELD IDIQ program, supporting the Golden Dome missile defense strategy [9] ZIM Integrated Shipping Services Ltd. - ZIM Integrated Shipping saw a 3.27% rise, closing at $19.88, with an intraday high of $20.14 and a low of $19.30; in extended trading, the stock rose 11.7% to $22.20 [11] - The increase followed the company receiving multiple competitive proposals for acquiring all outstanding shares, with the board evaluating these offers as part of a strategic review [12]

Core Viewpoint - Danish pharmaceutical giant Novo Nordisk (NVO.US) saw a nearly 10% increase in after-hours trading, reaching $52.79, following the FDA's approval of Wegovy (semaglutide) tablets for oral GLP-1 use in weight management [1] Group 1: Product Approval - Wegovy oral tablets are the first oral GLP-1 receptor agonist approved for weight management [1] - The approval is based on the OASIS and SELECT trial programs [1] Group 2: Clinical Trial Results - In the OASIS 4 trial, a daily dose of 25 mg semaglutide resulted in an average weight loss of 16.6% [1] - The weight loss effect achieved with Wegovy oral tablets is similar to that of the injectable Wegovy at 2.4 mg [1] Group 3: Market Launch - Wegovy oral tablets are expected to be available in the U.S. by early January 2026 [1]