Core Viewpoint - The U.S. CDC has adopted new recommendations for RSV vaccinations, lowering the age for eligible recipients, which has positively impacted Moderna's stock price and expanded its market potential for the RSV vaccine, mResvia [1][7]. Group 1: CDC Recommendations - The CDC has revised its recommendations to include adults aged 50-59 at higher risk of severe illness from RSV, advising them to receive a single dose of the vaccine [2][8]. - Previously, the guidance recommended vaccination for individuals aged 75 and older, and those aged 60-74 who were at high risk [2][8]. - The current HHS secretary, Robert F. Kennedy, Jr., officially adopted these recommendations, filling the role of CDC director, which is currently vacant [3]. Group 2: Impact on Moderna - The expanded CDC recommendations increase the addressable market for Moderna's RSV vaccine, mResvia, by including a new segment of eligible patients aged 50-59 [7][8]. - Despite the initial approval of mResvia for individuals aged 60 and older, the FDA recently expanded its label to include high-risk individuals aged 18-59 [9]. - Sales of mResvia have been modest since its commercial launch last year, as it was approved later in the contracting season compared to GSK's and Pfizer's vaccines [9][10]. Group 3: Competitive Landscape - Moderna is competing with GSK and Pfizer, both of which have already received approvals for their RSV vaccines for individuals aged 60 and older, with GSK's Arexvy also approved for high-risk individuals aged 50-59, and Pfizer's Abrysvo approved for high-risk individuals aged 18-59 [11]. - The earlier availability of GSK and Pfizer's vaccines has given them a dominant position in the market over Moderna [10]. Group 4: Stock Performance - Year to date, Moderna's stock has lost 27%, while the industry has only seen a 2% decline [5].

Key Takeaways GSK's Specialty Medicines unit drove 19% growth in 2024 and 17% in Q1 2025, led by HIV and oncology drugs. New U.S. approvals and strong research momentum support GSK's pipeline across respiratory, HIV and oncology. GSK trades at a forward P/E of 8.63, below the industry average, and continues to outperform peers and market.GSK (GSK) stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an opti ...

Core Viewpoint - Company announces the completion of the first cohort enrollment for Phase I clinical trials of SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) respiratory combination vaccine candidates [1][2] Group 1: Clinical Trial Details - The ongoing Phase I clinical trial for the combination vaccine candidates will enroll up to 192 elderly participants (aged 60-85), who will be randomly assigned to receive either SCB-1022 (RSV+hMPV), SCB-1033 (RSV+hMPV+PIV3), or the control group SCB-1019 (RSV) [2] - The clinical study aims to evaluate safety, reactogenicity, and immunogenicity of the vaccine candidates [2] Group 2: Previous Clinical Trial Results - In October 2024, the company will announce results from a Phase I clinical trial of its adjuvant-free RSV PreF vaccine candidate (SCB-1019) conducted on 70 elderly participants (aged 60-85), which showed potential best-in-class immunogenicity and tolerability characteristics when compared head-to-head with GSK's RSV vaccine AREXVY using AS01E adjuvant [1] - The clinical results support the further development and evaluation of SCB-1019 in combination with hMPV and PIV3 fusion pre-F trimer antigen, also developed using the protein trimerization platform [1]

Key Takeaways GSK's Arexvy may be approved in Europe for adults 18 following EMA's acceptance of its application. The RSV vaccine is currently cleared for adults 60 and high-risk individuals aged 50-59 years. Arexvy sales fell 57% in the first quarter of 2025 due to lower demand in the United States.GSK plc (GSK) announced that the European Medicines Agency (EMA) has accepted the regulatory application seeking approval to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vacci ...

Core Viewpoint - The approval of Moderna's RSV vaccine for younger adults indicates a potential easing of the previous administration's resistance to mRNA vaccine technology, allowing the company to target a larger market segment [1][2]. Group 1: Regulatory Approvals - The U.S. FDA has approved Moderna's RSV vaccine for adults under 60 who are at high risk of respiratory syncytial virus (RSV) infection, expanding its market reach [1]. - This approval follows the FDA's earlier authorization of the same vaccine for individuals aged 60 and above, marking the second mRNA vaccine product for Moderna after its COVID-19 vaccine [1][2]. Group 2: Competitive Landscape - Competitors such as Pfizer and GlaxoSmithKline have also received approvals for their RSV vaccines targeting high-risk populations, with Pfizer allowed to sell to those under 60 and GlaxoSmithKline to those aged 50 to 59 [1][2]. - The global market now features three adult RSV vaccines: Moderna's mRNA-1345, Pfizer's Abrysvo™, and GlaxoSmithKline's Arexvy™, each utilizing different technological platforms and formulations [2][3]. Group 3: Vaccine Technology and Efficacy - Moderna's mRNA-1345 vaccine employs a single mRNA strand encoding the pre-F protein, encapsulated in lipid nanoparticles, which allows for rapid updates and high neutralizing antibody titers with a single injection [3]. - In contrast, Pfizer and GlaxoSmithKline utilize recombinant protein vaccines with adjuvants, which may offer better immune persistence but require more complex manufacturing processes [3].

作为兼具医生与科学家双重背景的行业资深人士，Gurunathan在赛诺菲拥有超过20年的工作经历。其职 业生涯亮点包括： 转自：一度医药 英国制药巨头葛兰素史克（GSK）近日宣布一项关键人事任命：聘请赛诺菲（Sanofi）资深高管Sanjay Gurunathan博士担任疫苗与传染病研发部门负责人。这一消息由Gurunathan本人本周在领英平台正式公 布，标志着GSK在疫苗业务面临挑战之际，正通过引入外部顶尖人才重塑研发战略。 来源：市场资讯 以RSV疫苗Arexvy为例，这款针对老年人的创新疫苗原本被寄予厚望，但美国CDC仅建议为60岁以上特 定高风险人群接种，而非全面推广。这一政策导致Arexvy在美国市场的渗透率远低于预期，成为GSK疫 苗业务增长的主要拖累。 根据GSK官方声明，Gurunathan将常驻波士顿，直接向首席科学官Tony Wood汇报，全面负责GSK庞大 的疫苗与传染病产品线的创新与开发工作。这一职位此前由Phil Dormitzer担任，后者于2023年12月离职 创立咨询公司Dormitzer Biologics。 研发管理核心角色：曾任赛诺菲疫苗部门开发与生命周期管理组合战略负 ...

Moderna (MRNA) kicked off 2025 with mixed first-quarter results. While its streamlining efforts improved bottom-line numbers, the steep decline in revenues raises concerns.While sales of its COVID-19 vaccine continue to decline as expected in a post-pandemic market, Moderna is taking proactive steps to reshape its future. The company is swiftly advancing multiple pipeline candidates across late-stage development, with the intent to diversify its existing revenue base and launch multiple new products over th ...

Moderna (MRNA) incurred a loss of $2.52 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $2.92. In the year-ago period, the company had reported a loss of $3.07.Total revenues in the quarter were $108 million, which missed the Zacks Consensus Estimate of $127 million. Revenues declined around 35% year over year, owing to lower net product sales. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)More on MRNA’s Q1 EarningsModerna currently ...

Core Insights - GSK reported first-quarter sales of $9.46 billion, a 2% increase year-over-year and a 4% increase on a constant currency basis, surpassing analyst estimates of $7.46 billion [1] Vaccine Sales - Vaccine sales decreased by 8% to £2.09 billion, primarily due to lower demand for Arexvy and Shingrix [2] - Arexvy sales fell 57% to £78 million, while meningitis vaccine sales increased by 17% to £350 million [2] - Shingrix sales reached £867 million, down 8% [3] Specialty and General Medicines - Specialty Medicines sales grew by 16% to £2.93 billion, driven by strong performances in HIV, Respiratory, Immunology, Inflammation, and oncology [4] - General Medicines sales declined by 3% to £2.49 billion [4] Earnings and Future Plans - GSK reported a core EPS of $1.13, exceeding the consensus estimate of $1.04 [5] - The company plans to market five new specialty medicines this year, including the reintroduction of Blenrep for multiple myeloma [5] Guidance and Market Position - GSK reaffirms its 2025 guidance, expecting sales growth of 3% to 5% and core earnings per share growth of 6% to 8% [6] - Specialty Medicine sales are projected to increase by a low double-digit percentage, while vaccine revenue is expected to decline by a low single-digit percentage [7] Stock Performance - GSK stock rose by 3.57% to $40.37 during the premarket session [7]

We expect GSK plc (GSK) to surpass expectations when it reports first-quarter 2025 earnings on April 30, before the opening bell. The company’s earnings beat estimates by 11.32% in the last reported quarter.The Zacks Consensus Estimate for sales and earnings is pegged at $9.54 billion and $1.08 per American depositary share (ADS), respectively. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)Factors Shaping GSK’s Upcoming ResultsGSK reports financial figures under three segments — S ...