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SAN CARLOS, Calif. - Vaxcyte, Inc. (NASDAQ:PCVX), a clinical-stage vaccine company with a market capitalization of $4.09 billion, has advanced its modified VAX-31 infant Phase 2 study to the third and final stage, the company announced Wednesday. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 11.11, providing ample runway for its clinical programs.
The study is evaluating a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease compared to Prevnar 20, the current standard of care. While the company is not yet profitable, analysts maintain a strong bullish consensus on Vaxcyte’s prospects, with price targets ranging from $50 to $163 per share, as revealed by InvestingPro’s comprehensive analysis.
The company has modified the protocol to add a new "Optimized Dose" arm, where the majority of serotypes are dosed at 4.4mcg and the balance at 3.3mcg. This modification aims to elicit stronger immune responses in infants. Simultaneously, Vaxcyte discontinued enrollment in the Low Dose arm, while the Middle and High Dose arms continue as planned.
The randomized, double-blind, active-controlled study will enroll approximately 900 total participants. Vaxcyte expects to release topline safety, tolerability and immunogenicity data from both the primary immunization series and the booster dose by the end of the first half of 2027.
VAX-31 is designed to provide broader coverage against both currently circulating and historically prevalent pneumococcal strains. According to the company, the vaccine candidate has the potential to cover approximately 92% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five.
Streptococcus pneumoniae remains a leading cause of vaccine-preventable deaths among children under five globally. The bacteria can cause invasive pneumococcal disease, including meningitis and bacteremia, and non-invasive diseases such as pneumonia and otitis media.
The U.S. Food and Drug Administration has expanded Breakthrough Therapy designation for VAX-31 to include prevention of pneumonia caused by Streptococcus pneumoniae in addition to invasive pneumococcal disease in adults.
This information is based on a press release statement from Vaxcyte. Despite the stock experiencing a significant decline of over 70% in the past year, InvestingPro analysis suggests the company is currently undervalued. Investors seeking deeper insights can access the detailed Pro Research Report, which provides comprehensive analysis of Vaxcyte’s financial health, market position, and growth prospects among 1,400+ top US stocks.
In other recent news, Vaxcyte’s second-quarter update provided significant insights into its VAX-31 vaccine programs for both adults and infants. Guggenheim has adjusted its price target for Vaxcyte to $116 from $160, while maintaining a Buy rating, due to revised timelines for these vaccine programs. The firm highlighted that the updated timelines offer an improved investment setup ahead of expected Phase 3 adult trial results in 2026. Meanwhile, Cantor Fitzgerald has reaffirmed its Overweight rating on Vaxcyte, expressing confidence in the company’s future despite market speculations. Analyst Carter Gould from Cantor Fitzgerald noted that the upcoming Advisory Committee on Immunization Practices meeting is not expected to impact Vaxcyte directly, as pneumococcal disease is not on the agenda. Gould also emphasized that Vaxcyte’s vaccine programs are still several years from potential approval and recommendation by the ACIP. These developments are crucial for investors monitoring Vaxcyte’s progress in the biotech sector.
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