Core Viewpoint - Moderna has experienced a significant decline in stock performance and sales due to waning demand for its coronavirus vaccine, losing over 90% of its value since its peak in 2021 [1][2][7] Company Background - Moderna initially gained prominence during the pandemic, generating up to $18.4 billion in annual revenue from its coronavirus vaccine, leading to substantial profits [4] - The company has since faced challenges as vaccine demand decreased, and its RSV vaccine sales have also underperformed [5] Cost Management and R&D Focus - In response to declining sales, Moderna has initiated a cost realignment plan aiming to reduce GAAP operating costs by up to $1.7 billion by 2027 [6] - The company is prioritizing research and development, with plans to launch as many as 10 new products in the next three years, although these launches are not guaranteed [6] Future Product Pipeline - Moderna anticipates having around 10 products on the market in 10 years, including several cancer vaccines and a cytomegalovirus vaccine, along with potential respiratory virus vaccines [11] - The company has a strong success rate in late-stage trials, with an 83% probability of success in phase 3 trials compared to the industry average of 69% [12] Revenue Projections - By 2028, Moderna expects to break even on an operating cash cost basis and generate $6 billion in revenue, with new product launches from 2026 to 2028 projected to yield a compounded annual growth rate of 25% or more [12] - Even with partial success in product launches, Moderna could achieve significant revenue growth over the next decade [13]

Welcome back. Despite the market nearing new highs here, the healthc care sector is one of the few groups still negative on the year. Also the second worst performer for Q2, just behind energy.UNH, United Healthcare biggest drag on the sector down 42% since the start of April. David. All right.Meanwhile, RFK's new handpicked vaccine advisory committee voting on the RSV vaccine this morning and the flu shot this afternoon. Angelica Peoples has the latest for us. Angelica.Hey, David. That's right. So, in its ...

Let's change things up entirely here and get a news alert out of uh of RFK Junior's newly reworked vaccine panel. For that, we go over to Angelica Peele. She has the details for us.Angelica, good morning, David. Yeah, we have our first vote from this newly reconstituted vaccine panel. Remember, this is the committee that advises the CDC on how to use FDA approved vaccines, and they just voted 5 to2 to recommend that babies less than 8 months um 8 months old entering their first RSV vaccine can get Merc's RS ...

MORRISTOWN, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (OTCQB:HEPA), a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC), today announced that it has successfully completed the process of transitioning to the OTCQB Venture Market. The Company’s common stock begins trading on the OTCQB Venture Marke ...

Group 1 - The investment association PortfolioManager has published an updated common prospectus due to the addition of two new share classes to be traded on Nasdaq Copenhagen A/S, with the first trading day set for June 25, 2025 [1] - Information regarding the new share classes includes the number of investors, the number of circulating shares, and the total assets in DKK [2] - The prospectus is attached for further details, and inquiries can be directed to the CEO of Fundmarket A/S, Nina Trolle Boldt [2]

自17位美国疾病控制与预防中心(CDC)疫苗咨询委员会(ACIP)成员在6月9日被全部解除职务以来，围绕 美国CDC疫苗咨询委员会改组的争议持续不断。 当地时间6月16日，被解除职务的17位委员在《美国医学会杂志》(JAMA)联合发文警告，这一改革将严 重削弱美国疫苗计划，并可能影响民众获得救命疫苗的机会。 过去一周，美国疫苗公司莫德纳(MRNA.O)股价下跌9.2%，诺瓦瓦克斯(NVAX.O)下跌12.4%，默沙东 (MRK.N)下跌1.4%，辉瑞(PFE.N)微涨0.1%。 ACIP是美国疾控中心下属的重要咨询机构，负责评估新疫苗的临床试验数据、副作用报告、成本效益 及公共卫生影响，其决策直接影响儿童疫苗接种计划、医保报销范围及政府采购目录。 解除ACIP原17位委员职务的决定是由美国卫生与公众服务部(HHS)新任部长罗伯特.F.肯尼迪(Robert F.Kennedy Jr.)做出的。 针对解职原因，肯尼迪称：原委员会成员与疫苗企业存在利益关系，疫苗审批流于形式，委员会从未建 议反对任何疫苗。他以1997年轮状病毒疫苗Rotashield审批事件为例，指控ACIP对疫苗审查不严，当年 该疫苗因不良反应被 ...

金十数据整理：每日美股市场要闻速递（6月17日 周二） 重要新闻 5. 花旗预测，金价将因需求疲软和美联储降息下跌，未来几个季度金价预计将回落至每盎司3000美元以 下。 6. 美国参议院提案称将在2028年结束风能和太阳能抵免，核能、水力发电和地热能的激励措施将持续到 2036年。 个股新闻 6. 甲骨文(ORCL.N)正在推出一个项目，此项目将助力供应商更便捷地向美国国防部销售包括人工智能 在内的技术。 7. 礼来(LLY.N)正在就收购基因编辑初创企业Verve Therapeutics (VERV.US)进行深入谈判，交易金额最 高可达13 亿美元。 8. 香港联交所权益披露资料显示，6月10日至6月13日，王兴累计减持了573.7万股理想汽车(LI.O)汽车， 套现金额共超6亿港元。 9. OpenAI正向其最大股东微软(MSFT.O)寻求新的财务让步，前者希望微软(MSFT.O)在重组后的部门中 拥有约33%的股份，以换取其放弃未来利润分配权。 1. 特朗普：药品关税即将到来。 2. 特朗普：从未以任何方式与伊朗就和谈联系。 3. 美联储传声筒：若非关税对价格构成的风险，美联储本周将准备降息。 4 ...

三叶草生物正在进行的联合疫苗候选产品I期临床试验将入组多达192名老年受试者(60-85岁)，受试者将 随机分配接种SCB-1022(RSV+hMPV),SCB-1033(RSV+hMPV+PIV3)或对照组SCB-1019(RSV)。该临床研 究将评估安全性，反应原性及免疫原性。 格隆汇6月17日丨三叶草生物-B(02197.HK)公告，公司欣然宣布，一项评估SCB-1022(RSV+hMPV)及 SCB-1033(RSV+hMPV+PIV3)呼吸道联合疫苗候选产品的I期临床试验已完成首批受试者入组。该等疫 苗候选产品开发的融合前稳定的F(PreF)三聚体亚单位疫苗抗原基于三叶草生物的蛋白质三聚体化疫苗 技术平台。 三叶草生物于2024年10月公布其未使用佐剂的RSVPreF疫苗候选产品(SCB-1019)在70名老年受试者(60- 85岁)中开展的I期临床试验结果，与葛兰素史克(GSK)使用AS01E佐剂的RSV疫苗AREXVY进行头对头 比较后，临床结果显示SCB-1019具备潜在同类最佳的免疫原性与耐受性综合特征。该临床结果支持本 公司将SCB-1019与同样利用蛋白质三聚体化平台开发的hMPV及PI ...

政策动向 国家药监局征求意见：纳入创新药临床试验审评审批30日通道的申请应当为中药、化学药品、生物制品 1类创新药 6月16日，国家药监局综合司公开征求《关于优化创新药临床试验审评审批有关事项的公告（征求意见 稿）》意见，其中提出，纳入创新药临床试验审评审批30日通道的申请，应当为中药、化学药品、生物 制品1类创新药，能够按要求提交申报资料，并需满足以下条件之一：（一）国家支持的重点创新药。 获国家全链条支持创新药发展政策体系支持的具有明显临床价值的重点创新药品种。（二）入选国家药 品监督管理局药品审评中心儿童药星光计划、罕见病关爱计划的品种。（三）全球同步研发品种。全球 同步研发的Ⅰ期、Ⅱ期临床试验和III期国际多中心临床试验，以及中国主要研究者牵头开展的国际多中 心临床试验。 药械审批 "多动症"新药上市申请获受理并纳入优先审评 6月16日，上海爱科百发生物医药技术股份有限公司（下称" 爱科百发"）宣布其新药爱智达（通用名： 丝右哌甲酯/右哌甲酯复方胶囊；代号：AK0901）的新药上市申请（NDA）已经获得中国国家药品监督 管理局（NMPA）药品审评中心（CDE）正式受理，并将其已纳入"优先审评审批"程序 ...

Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.