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].

Core Insights - GSK has appointed Dr. Sanjay Gurunathan from Sanofi as the head of its vaccine and infectious disease R&D department, indicating a strategic shift in response to challenges in its vaccine business [1][5] - Gurunathan brings over 20 years of experience from Sanofi, where he held significant roles in vaccine development and regulatory approval [3][4] Company Developments - Gurunathan will be based in Boston and report directly to GSK's Chief Scientific Officer, Tony Wood, overseeing the innovation and development of GSK's extensive vaccine and infectious disease product line [3] - The previous head of this department, Phil Dormitzer, left GSK in December 2023 to start a consulting firm [3] Industry Context - The recent talent exchange between GSK and Sanofi reflects a competitive landscape in the global vaccine industry, which is undergoing strategic adjustments [5] - GSK's vaccine sales have faced pressure, with a reported 8% year-over-year decline in Q1 2025, amounting to £2.1 billion (approximately $2.8 billion) [5] Market Challenges - The CDC's restrictive immunization guidelines have limited the market potential for GSK's RSV vaccine, Arexvy, which is now only recommended for specific high-risk groups aged 60 and above [6] - GSK has adjusted its full-year vaccine revenue expectations to a single-digit decline due to these sales challenges [5] Future Outlook - GSK's vaccine pipeline includes promising projects targeting COVID-19, HIV, and influenza, indicating potential for future growth [7] - Gurunathan's role will likely focus on optimizing the R&D pipeline and enhancing the market presence of existing products, which is crucial for GSK's strategic direction in the evolving vaccine market [7]

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 ...

Core Viewpoint - Moderna reported a narrower loss of $2.52 per share in Q1 2025, compared to a loss of $3.07 in the same period last year, but total revenues of $108 million fell short of expectations and declined approximately 35% year over year due to lower product sales [1][2][3] Financial Performance - Total revenues for Q1 2025 were $108 million, missing the Zacks Consensus Estimate of $127 million [1] - Product sales decreased by 49% year over year to $86 million, primarily due to lower sales of the COVID-19 vaccine Spikevax [2] - Spikevax sales were $84 million in the quarter, down from $167 million in the previous year, attributed to lower vaccination rates and the normalization of COVID into a seasonal market [3] - mResvia sales were only $2 million, significantly below the estimated $70 million, due to late approval and recommendations [4] - The company generated $22 million from grants, collaborations, licensing, and royalty revenues, with no revenues recorded in the year-ago period [6] Cost Management - Selling, general and administrative (SG&A) expenses were $212 million, down 23% year over year due to cost-cutting measures [7] - Research & development (R&D) expenses decreased by 19% to $856 million, driven by reduced clinical spending [7] Financial Guidance - Moderna reiterated its total revenue guidance for 2025, expecting revenues between $1.5 billion and $2.5 billion, with around $0.2 billion expected in the first half of the year [8] - Full-year R&D expenses are projected to be around $4.1 billion, while SG&A expenses are expected to be approximately $1.1 billion [9] - Capital expenditure is anticipated to be around $0.4 billion in 2025 [9] Pipeline Developments - Moderna submitted three regulatory filings to the FDA in Q4 2024, including for mRNA-1283 (next-generation COVID-19 vaccine) and mResvia for high-risk adults [12] - A third filing for the COVID-19 and influenza combination vaccine, mRNA-1083, is pending further data, which may delay launch plans [13] - The company has over 40 mRNA-based investigational candidates in various clinical stages, including cancer therapies [16] - Moderna is co-developing intismeran autogene with Merck, evaluating it in pivotal phase III studies for melanoma and non-small cell lung cancer [17][18] - The company plans to start a registrational study for mRNA-3705, a therapeutic candidate for methylmalonic acidemia, later this year [19]

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 ...