GSK plc GSK announced that the European Commission (EC) has approved a single-vial, fully liquid presentation of its meningococcal vaccine, Menveo (MenACWY) for active immunization in children aged two years, adolescents as well as adults.
The single-vial, fully liquid presentation of Menveo is likely to simplify the vaccination process against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y.
The fully liquid presentation of the vaccine will help healthcare providers with an option that does not require reconstitution before its use. Until now, Menveo was approved as a lyophilised/liquid formulation.
Year to date, shares of GSK have lost 7.4% compared with the industry’s decline of 7.9%.
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More on the Latest EU Nod for GSK's Menveo
The EC’s approval for the liquid presentation of Menveo was based on positive data from two phase IIb studies. The primary and secondary outcomes of these studies, backed by post-hoc pooled analyses showed that the fully liquid formulation of Menveo has similar immunogenicity, tolerability and a similar safety profile to the existing lyophilised/liquid formulation.
In September 2024, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the use of a single-vial, fully liquid presentation of Menveo.
Menveo generated sales worth £337 million during the first nine months of 2024, reflecting an increase of 19% on a year-over-year basis.
Per the company, the approval for the fully liquid formulation of Menveo is likely to support the vaccine uptake and should drive sales in future quarters.
GSK's Diversified Vaccine Pipeline
GSK boasts a broad and diversified vaccine portfolio that targets infectious diseases such as meningitis, shingles, flu, polio and more.
GSK’s 5-in-1 meningococcal ABCWY vaccine candidate, MenABCWY, is currently under review in the United States. A decision from the FDA is expected on Feb. 14, 2025.
The MenABCWY vaccine candidate combines the antigenic components of GSK’s two licensed meningococcal vaccines, Bexsero (MenB) and Menveo. The MenABCWY combination targets five serogroups of the bacteria Neisseria meningitides (A, B, C, W, and Y), which is primarily responsible for most IMD cases globally.
Per management, a potential approval of this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and lead to a simplified immunization schedule.
GSK is focusing on accelerating the vaccine pipeline. The company has a leading suite of vaccine platform technologies, including next-generation mRNA, multiple antigen-presenting systems, as well as adjuvant systems.
GSK's Zacks Rank & Key Picks
GSK currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 23.1%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 41%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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