GSK’s new 5-in-1 meningitis vaccine gets FDA approval

Published 18/02/2025, 13:28
GSK’s new 5-in-1 meningitis vaccine gets FDA approval

GSK plc (LSE/NYSE: GSK), a $73.75 billion market cap pharmaceutical giant currently trading below its InvestingPro Fair Value, announced the approval of its Penmenvy vaccine by the US Food and Drug Administration (FDA).

The company, maintaining an impressive 71.81% gross profit margin, continues to demonstrate its strength in the pharmaceutical sector. The newly approved vaccine is designed to protect individuals aged 10 through 25 years against five common serogroups of Neisseria meningitidis (A, B, C, W, and Y), which are known to cause invasive meningococcal disease (IMD).

The approval, announced today, is based on positive outcomes from two phase III trials involving over 4,800 participants. These studies confirmed the vaccine’s safety, tolerability, and immune response, with safety data aligning with that of GSK’s existing meningococcal vaccines.

Chief Scientific Officer at GSK, Tony Wood, expressed optimism about the potential to increase meningococcal vaccination coverage in the United States, particularly against serogroup B, which poses a heightened risk for teens and young adults.

The integration of Penmenvy into vaccination practices may simplify the immunization process and expand protection against the five disease-causing serogroups. Currently, less than 13% of US adolescents receive the recommended two-dose MenB vaccination series, and GSK leads the market with three out of every four MenB doses administered in the US.

According to InvestingPro analysis, GSK maintains a strong financial health score of "GOOD," supporting its position as a prominent player in the pharmaceuticals industry. The company’s stable 4.35% dividend yield and consistent dividend payments for 25 consecutive years demonstrate its reliable shareholder returns.

Judy Klein, President and Founder of Unity Consortium, welcomed the new vaccine as a means to protect more adolescents from meningococcal disease. The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to vote on recommendations for the use of GSK’s MenABCWY vaccine on February 26, 2025.

IMD is a rare but severe illness that can be fatal within 24 hours of onset. Adolescents and young adults are particularly at risk due to behaviors such as living in close quarters and sharing personal items, which facilitate the spread of the bacteria causing IMD.

Penmenvy combines the antigenic components of GSK’s Bexsero and Menveo vaccines into a single vaccine, streamlining the vaccination process. GSK, a global biopharma company, continues to focus on preventing disease through innovative vaccinations.

This report is based on information from a SEC filing. For deeper insights into GSK’s financial health, growth prospects, and detailed analysis, including 8 additional ProTips and comprehensive valuation metrics, visit InvestingPro, where you can access the full Pro Research Report, available for over 1,400 US stocks.

In other recent news, GlaxoSmithKline (NYSE:GSK) has been in the spotlight due to several key developments. Morgan Stanley (NYSE:MS) initiated coverage on GSK’s shares, setting an underweight rating with a price target of GBP14.50, citing concerns over headwinds from the Inflation Reduction Act and disruptions in the vaccine market. Stifel analysts anticipate modest growth in sales and earnings per share for GSK, albeit with uncertainties in the vaccines market potentially impacting new product launches.

In a separate development, CFRA revised GSK’s stock price target to $40.00 from $42.00, maintaining a hold rating. This adjustment is primarily due to concerns about the company’s Vaccines segment performance. However, GSK’s 2024 earnings were reported to be in line with CFRA’s expectations, and the company has provided guidance for a 3%-5% increase in sales and a 6%-8% rise in core operating profit for 2025.

Finally, GSK reported fourth-quarter revenue that surpassed analyst estimates, driven by strong performance in its Specialty Medicines segment.

The company expects revenue growth of 3-5% and adjusted EPS growth of 6-8% for 2025 and has announced plans for a £2 billion share buyback program over the next 18 months.

Despite an earnings miss, the company’s robust sales growth and positive guidance have been noted by investors.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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