GSK’s RSV vaccine gets positive opinion for broader age group
GSK plc (LSE/NYSE: GSK) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 50-59 at increased risk of RSV disease. This marks the first recommendation by CHMP for an RSV vaccine for this age group, extending the vaccine’s reach beyond the current approval for adults aged 60 and over.
The CHMP’s positive opinion is a significant step towards the European Commission’s expected decision on the vaccine’s marketing authorization by September 2024. Arexvy has been available in Europe for the older age group since June 2023. The vaccine aims to prevent lower respiratory tract disease caused by RSV, a common virus that can lead to severe respiratory illness and even death, particularly in older adults and those with certain medical conditions.
The decision is supported by phase III trial data, which evaluated the immune response and safety of the vaccine in the 50-59 age group. Adults with chronic health issues such as COPD, asthma, heart failure, and diabetes are at an increased risk of serious RSV complications.
In Europe, RSV leads to roughly 270,000 hospitalizations and 20,000 in-hospital deaths annually among those 60 years and older. The disease burden in the 50-59 age group with increased risk mirrors that of the general population over 60.
The vaccine, which consists of a recombinant RSV glycoprotein F combined with GSK’s proprietary AS01E adjuvant, has also received approval in the United States for the 50-59 age group as of June 7, 2024. GSK is pursuing regulatory submissions in Japan and other regions, with reviews currently in progress.
Further trials are underway to assess the vaccine’s effectiveness in adults aged 18-49 with certain medical conditions and immunocompromised individuals, with results expected in the second half of 2024.
This announcement is based on a press release statement.
In other recent news, GlaxoSmithKline (NYSE:) has been at the center of several developments. Argus has maintained a ‘Buy’ rating for GSK, raising the price target to $45.00, citing the company’s recent regulatory approvals for treatments addressing RSV, lupus, and HIV. The company’s stock attractiveness is further enhanced by its dividend yield of approximately 3.8%.
In contrast, Citi has lowered its price target for GSK shares due to narrowed prospects for the Arexvy vaccine. This adjustment follows the Advisory Committee on Immunization Practices’ decision to limit the eligible age group for Arexvy, leading to a reduction in peak sales expectations.
GSK has also secured exclusive rights to develop, manufacture, and commercialize mRNA vaccines for influenza and COVID-19 from CureVac. This agreement involves an upfront payment of €400 million with potential future payments totaling €1.05 billion, based on various milestones.
Simultaneously, GSK reported a 100% response rate in a rectal cancer study with Jemperli, a potential new treatment option. However, the company is facing a lawsuit from Valisure over allegations related to the concealment of cancer risks associated with its heartburn medication Zantac.
These are the recent developments for GSK.
InvestingPro Insights
As GSK plc (LSE/NYSE: GSK) continues to make strides in expanding the approval of its RSV vaccine, Arexvy, investors may take note of the company’s financial health and market performance. According to real-time data from InvestingPro, GSK has a robust market capitalization of $81.96 billion, underscoring its significant presence in the pharmaceutical industry. The company’s P/E ratio stands at a favorable 14.24, with an adjusted figure for the last twelve months as of Q1 2024 at an even more attractive 9.55, suggesting that the stock may be undervalued relative to its earnings.
InvestingPro Tips highlight GSK’s strong shareholder yield and the fact that two analysts have revised their earnings upwards for the upcoming period, signaling confidence in the company’s financial prospects. Additionally, GSK’s valuation implies a strong free cash flow yield, which is a positive indicator for investors looking for companies with solid financial health. For those considering an investment in GSK, there are 10 additional InvestingPro Tips available, offering deeper insights into the company’s performance and potential.
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