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Vaxcyte Stock Hits Record High on Pneumococcal Vaccine Study Results
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Shares of Vaxcyte (PCVX - Free Report) rose more than 36% on Tuesday after it reported positive top-line results from a phase I/II study on VAX-31, which is an investigational 31-valent pneumococcal conjugate vaccine (PCV). The study was conducted on adults aged 50 years and older.
Data from the study showed that the study participants who received VAX-31 achieved ‘robust’ immune responses for all 31 serotypes across all three dose levels (low, medium and high) in a six-month evaluation period. While the vaccine met or exceeded the regulatory immunogenicity criteria for all the serotypes at the high and middle dose levels, it did not meet the same for two serotypes at the low dose level.
The results from the phase I/II study equal or even exceed the immune responses generated by Pfizer’s (PFE - Free Report) Prevnar 20, which is the current standard of care in the PCV space. The Pfizer vaccine is approved for the prevention of invasive pneumococcal disease (IPD) caused by 20 serotypes in individuals aged six weeks and older.
Comparison of VAX-31 With Prevnar 20
Data from the study showed that VAX-31 was shown to be well-tolerated by study participants and demonstrated a safety profile similar to Prevnar 20 across all three dose levels. VAX-31 covers 31 serotypes, which includes all the 20 serotypes found in Pfizer’s Prevnar 20.
While VAX-31 achieved the non-inferiority criteria for all the 20 common serotypes at the high and medium dose levels, it could meet the same for 18 serotypes at the low dose level.
At the high dose level, average immune responses generated by VAX-31 were greater for 18 of 20 serotypes compared to Prevnar 20, with seven serotypes achieving statistically higher immune responses. For the medium dose, the average immune responses were greater in 13 of 20 serotypes compared to the Pfizer vaccine, with five serotypes achieving statistically higher immune responses.
For the additional 11 serotypes that are unique to VAX-31 and not found in Prevnar-20, all three dose levels met the superiority criteria.
PCVX Stock Performance
Following the results announcement, shares of Vaxcyte hit an all-time high price of $119.27. The results came as a shock to several Wall Street analysts who did not expect the company to report such encouraging results. Some of these analysts pointed out that the additional carrier proteins required to handle the vaccine’s extra immunogen are expected to reduce antibody responses for some serotypes. Analysts had initially expected that VAX-31 was likely to miss the non-inferiority criteria in some of the serotypes shared with Prevnar-20.
Through this broader coverage, Vaxcyte intends to prevent more than 95% of IPDs in older adults (aged 50 years and older) in the United States.
Year to date, the stock has surged 75.4% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Vaxcyte’s Plans in the PCV Space
Based on the encouraging study results, Vaxcyte plans to meet with the FDA to advance the VAX-31 to late-stage development. Subject to regulatory approvals, it intends to start a pivotal late-stage study on the vaccine by mid-2025, with topline results expected in 2026.
The company is also planning to start a mid-stage study in first-quarter 2025 evaluating VAX-31 for use in infants.
Apart from VAX-31, management is also evaluating PCV-24, a 24-valent PCV candidate in a phase II study in infants. Data from this study is expected by the end of first-quarter 2025.
Other Drugmakers in the PCV Space
Pfizer is a key player in the PCV vaccine space. Apart from Prevnar 20, PFE also markets another pneumococcal vaccine, Prevnar 13, which contains 13 serotypes and has the FDA’s approval for use in individuals aged six weeks and older. In first-half 2024, Pfizer recorded nearly $3.1 billion from combined sales of Prevnar 13 and Prevnar 20, up 2% (excluding Fx) from the year-ago period.
Pfizer’s vaccines face stiff competition from Merck (MRK - Free Report) , which also markets two PCV vaccines – Capvaxive and Vaxneuvance. MRK received FDA approval for Vaxneuvance in 2021 for 15 serotypes in older adults.Merck generated $408 million from Vaxneuvance product sales in the first six months of 2024, up 51% year over year. The FDA recently approved Capvaxive for 21 serotypes, which account for 84% of all IPDs in older adults. Merck will start recording Capvaxive sales from third-quarter 2024 onward.
GSK plc (GSK - Free Report) has a 24-valent PCV in its pipeline, which is currently in phase II development. The vaccine candidate was added to GSK’s portfolio with the acquisition of the Massachusetts-based privately held biotech Affinivax in 2022. The vaccine is being developed using the Affinivax Multiple Antigen-Presenting System technology.
Image: Bigstock
Vaxcyte Stock Hits Record High on Pneumococcal Vaccine Study Results
Shares of Vaxcyte (PCVX - Free Report) rose more than 36% on Tuesday after it reported positive top-line results from a phase I/II study on VAX-31, which is an investigational 31-valent pneumococcal conjugate vaccine (PCV). The study was conducted on adults aged 50 years and older.
Data from the study showed that the study participants who received VAX-31 achieved ‘robust’ immune responses for all 31 serotypes across all three dose levels (low, medium and high) in a six-month evaluation period. While the vaccine met or exceeded the regulatory immunogenicity criteria for all the serotypes at the high and middle dose levels, it did not meet the same for two serotypes at the low dose level.
The results from the phase I/II study equal or even exceed the immune responses generated by Pfizer’s (PFE - Free Report) Prevnar 20, which is the current standard of care in the PCV space. The Pfizer vaccine is approved for the prevention of invasive pneumococcal disease (IPD) caused by 20 serotypes in individuals aged six weeks and older.
Comparison of VAX-31 With Prevnar 20
Data from the study showed that VAX-31 was shown to be well-tolerated by study participants and demonstrated a safety profile similar to Prevnar 20 across all three dose levels. VAX-31 covers 31 serotypes, which includes all the 20 serotypes found in Pfizer’s Prevnar 20.
While VAX-31 achieved the non-inferiority criteria for all the 20 common serotypes at the high and medium dose levels, it could meet the same for 18 serotypes at the low dose level.
At the high dose level, average immune responses generated by VAX-31 were greater for 18 of 20 serotypes compared to Prevnar 20, with seven serotypes achieving statistically higher immune responses. For the medium dose, the average immune responses were greater in 13 of 20 serotypes compared to the Pfizer vaccine, with five serotypes achieving statistically higher immune responses.
For the additional 11 serotypes that are unique to VAX-31 and not found in Prevnar-20, all three dose levels met the superiority criteria.
PCVX Stock Performance
Following the results announcement, shares of Vaxcyte hit an all-time high price of $119.27. The results came as a shock to several Wall Street analysts who did not expect the company to report such encouraging results. Some of these analysts pointed out that the additional carrier proteins required to handle the vaccine’s extra immunogen are expected to reduce antibody responses for some serotypes. Analysts had initially expected that VAX-31 was likely to miss the non-inferiority criteria in some of the serotypes shared with Prevnar-20.
Through this broader coverage, Vaxcyte intends to prevent more than 95% of IPDs in older adults (aged 50 years and older) in the United States.
Year to date, the stock has surged 75.4% compared with the industry’s 0.6% growth.
Vaxcyte’s Plans in the PCV Space
Based on the encouraging study results, Vaxcyte plans to meet with the FDA to advance the VAX-31 to late-stage development. Subject to regulatory approvals, it intends to start a pivotal late-stage study on the vaccine by mid-2025, with topline results expected in 2026.
The company is also planning to start a mid-stage study in first-quarter 2025 evaluating VAX-31 for use in infants.
Apart from VAX-31, management is also evaluating PCV-24, a 24-valent PCV candidate in a phase II study in infants. Data from this study is expected by the end of first-quarter 2025.
Other Drugmakers in the PCV Space
Pfizer is a key player in the PCV vaccine space. Apart from Prevnar 20, PFE also markets another pneumococcal vaccine, Prevnar 13, which contains 13 serotypes and has the FDA’s approval for use in individuals aged six weeks and older. In first-half 2024, Pfizer recorded nearly $3.1 billion from combined sales of Prevnar 13 and Prevnar 20, up 2% (excluding Fx) from the year-ago period.
Pfizer’s vaccines face stiff competition from Merck (MRK - Free Report) , which also markets two PCV vaccines – Capvaxive and Vaxneuvance. MRK received FDA approval for Vaxneuvance in 2021 for 15 serotypes in older adults.Merck generated $408 million from Vaxneuvance product sales in the first six months of 2024, up 51% year over year. The FDA recently approved Capvaxive for 21 serotypes, which account for 84% of all IPDs in older adults. Merck will start recording Capvaxive sales from third-quarter 2024 onward.
GSK plc (GSK - Free Report) has a 24-valent PCV in its pipeline, which is currently in phase II development. The vaccine candidate was added to GSK’s portfolio with the acquisition of the Massachusetts-based privately held biotech Affinivax in 2022. The vaccine is being developed using the Affinivax Multiple Antigen-Presenting System technology.
Vaxcyte, Inc. Price
Vaxcyte, Inc. price | Vaxcyte, Inc. Quote
PCVX’s Zacks Rank
Vaxcyte currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.