Stock market today: S&P 500 climbs as health care, tech gain; Nvidia earnings loom
SAN CARLOS, Calif. - Vaxcyte, Inc. (NASDAQ:PCVX), a vaccine innovation company valued at $10.78 billion, has announced the commencement of the final stage of its Phase 2 study for VAX-31, a pneumococcal conjugate vaccine candidate. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, providing stability for its ongoing clinical programs. Following a review of Stage 1 safety and tolerability data, the study has progressed to Stage 2, where the vaccine’s safety, tolerability, and immunogenicity will be further evaluated in healthy infants.
VAX-31 is designed to provide broad coverage against invasive pneumococcal disease (IPD) and acute otitis media, which are significant health concerns for children under five in the U.S. The vaccine candidate aims to protect against approximately 94% of IPD cases and 93% of acute otitis media in this age group.
The Phase 2 infant study is a randomized, double-blind, active controlled trial, comparing VAX-31 to the existing Prevnar 20 (PCV20) vaccine. Approximately 750 infants will receive either VAX-31 or PCV20 at three ascending dose levels, followed by a booster dose. The primary immunization series consists of three doses given at two, four, and six months of age, with a booster at 12-15 months of age.
The company expects to release topline safety, tolerability, and immunogenicity data from the primary immunization series in mid-2026, with booster dose data to follow approximately nine months later. While InvestingPro analysis indicates the company isn’t currently profitable, Wall Street remains optimistic, with analysts maintaining a strong buy consensus and setting price targets ranging from $135 to $163 per share.
Vaxcyte’s CEO, Grant Pickering, highlighted the significance of advancing to Stage 2, stating that pneumococcal conjugate vaccines (PCVs) have been a cornerstone of vaccination schedules for decades. Vaxcyte’s VAX-24 and VAX-31 PCV franchise aims to set a new standard by expanding protection against both currently and historically circulating strains.
The broader coverage potential of VAX-31 is also reflected in the Phase 2 infant study’s design, which includes evaluating immune responses for the 20 common and 11 unique serotypes in VAX-31 compared to PCV20.
Vaxcyte’s pipeline also includes VAX-A1, VAX-PG, and VAX-GI, targeting other bacterial infectious diseases. The company’s approach to vaccine development employs modern synthetic techniques, such as the XpressCF™ cell-free protein synthesis platform, to create high-fidelity vaccines.
This advancement in the VAX-31 infant study marks a key milestone for Vaxcyte, as it continues to develop vaccines aimed at protecting against bacterial diseases. The company’s robust financial health is reflected in its impressive current ratio of 17.88, indicating strong liquidity to fund its development pipeline. Investors can access additional financial metrics and 6 more exclusive ProTips about Vaxcyte through InvestingPro. The information in this article is based on a press release statement and InvestingPro data.
In other recent news, Vaxcyte has been making significant strides with its pneumococcal conjugate vaccine, VAX-31. The U.S. Food and Drug Administration (FDA) recently cleared the Investigational New Drug (IND) application for VAX-31 in infants and granted it a Breakthrough Therapy designation for adults. This follows the company’s strong clinical data and positive Phase 1/2 trial results, which have been applauded by Goldman Sachs and Jefferies.
Vaxcyte’s financial standing is robust, with the company reportedly holding approximately $3.3 billion in cash reserves. This financial strength is expected to support the company’s operational plans effectively as it continues to develop its vaccine.
In addition to these developments, Vaxcyte has entered into an amended and restated lease agreement to expand its corporate headquarters in San Carlos, California. This expansion reflects Vaxcyte’s growth and ongoing commitment to its operations and research in the field of biological products.
Moreover, Leerink Partners has reiterated its Outperform rating on Vaxcyte, noting the company’s progress with its pipeline, including the upcoming VAX-24 Phase 2 infant data expected at the end of the first quarter of 2025.
These developments represent recent strides made by Vaxcyte in its mission to address next-generation vaccine challenges.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.