Vaxcyte Initiates Phase 3 Trial for VAX-31 Vaccine, Aiming 95% Coverage
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
0mins
Should l Buy PCVX?
Source: Globenewswire
- Trial Design Finalized: Vaxcyte has finalized the design of the Phase 3 noninferiority trial for VAX-31 in consultation with the FDA, aiming to enroll approximately 4,000 participants, marking a significant milestone in vaccine development.
- Data Release Timeline: The company expects to report topline safety, tolerability, and immunogenicity data from the OPUS trial in Q4 2026, which will serve as a cornerstone for the VAX-31 Biologics License Application (BLA).
- Increased Coverage: VAX-31 is designed to cover approximately 95% of invasive pneumococcal disease, representing a 14-34% increase in coverage compared to existing vaccines, significantly enhancing its competitive position in the adult vaccine market.
- Strategic Implications: By maintaining pressure on both currently circulating and historically disease-causing serotypes, VAX-31 aims to provide broader protection for adults, addressing the growing vaccine demand and reinforcing the company's leadership in the vaccine market.
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Analyst Views on PCVX
Wall Street analysts forecast PCVX stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 54.950
Low
50.00
Averages
104.80
High
163.00
Current: 54.950
Low
50.00
Averages
104.80
High
163.00
About PCVX
Vaxcyte Inc. is a clinical-stage vaccine innovation company. The Company is engaged in developing spectrum conjugate and protein vaccines to prevent or treat bacterial infectious diseases. Its pipeline includes VAX-31, a 31-valent PCV candidate advancing to a Phase III adult clinical program and being evaluated in a Phase II infant clinical program, which is being developed for the prevention of invasive pneumococcal disease (IPD) in adults and infants and is the broadest-spectrum pneumococcal conjugate vaccine (PCV) candidate in the clinic. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is being evaluated in a Phase II infant study. Its pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Vaxcyte Initiates Phase 3 Trial for VAX-31 Vaccine
- Trial Launch: Vaxcyte announced the dosing of first participants in the OPUS-3 Phase 3 trial for VAX-31, a next-generation 31-valent pneumococcal conjugate vaccine aimed at enhancing immune responses against pneumococcus, which is expected to significantly improve vaccination outcomes in adults.
- Trial Scale and Design: The study will enroll approximately 720 adults aged 50 and older across 30 U.S. sites, with participants randomized to receive either VAX-31 or PCV20, assessing safety, tolerability, and immunogenicity, particularly in boosting immune responses in previously vaccinated individuals.
- Enhanced Vaccine Coverage: VAX-31 is designed to cover approximately 95% of invasive pneumococcal disease and 88% of pneumococcal pneumonia, potentially providing 14-34% broader invasive disease coverage and 19-31% broader pneumonia coverage compared to current vaccines, which may significantly reduce the incidence of related diseases.
- Future Data Expectations: Vaxcyte's broader Phase 3 adult program for VAX-31 includes OPUS-1 and OPUS-2, with key data expected in Q4 2026 and H1 2027 respectively, further advancing the vaccine's market application and Biologics License Application (BLA).
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Vaxcyte Prices Public Offering at $550 Million
- Offering Size: Vaxcyte announced the pricing of 11 million shares at $50.00 each, aiming for gross proceeds of $550 million, reflecting strong market confidence in its vaccine innovations.
- Underwriter Arrangement: The offering is managed by prominent financial institutions including BofA Securities and Jefferies, indicating positive market expectations for Vaxcyte's future growth and enhancing investor confidence.
- Additional Share Option: Vaxcyte granted underwriters a 30-day option to purchase an additional 1.65 million shares at the same price, a strategy that could further enhance the company's financing capabilities and support its R&D initiatives.
- Closing Timeline: The offering is expected to close on February 2, 2026, and if successful, will provide Vaxcyte with ample funding to support its vaccine development and market expansion plans.
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Vaxcyte Initiates Phase 3 Trials for VAX-31, Market Cap Around $7 Billion
- Vaccine Development Progress: Vaxcyte has initiated the Phase 3 OPUS-2 trial for VAX-31 in participants aged 50 and above, aiming to enroll around 1,300 individuals, showcasing the company's potential leadership in pneumococcal disease prevention.
- Manufacturing Investment: The company plans to start a custom fill-finish line in North Carolina in Q1 2026 with a $1 billion investment, enhancing its vaccine manufacturing capabilities and further solidifying its market position.
- Clinical Trial Timeline: Topline data from both OPUS-2 and OPUS-3 trials are expected in the first half of 2027, indicating Vaxcyte's strong commitment to expanding its vaccine portfolio, which could drive future revenue growth.
- Strong Market Performance: Despite mixed market conditions, Vaxcyte's stock rose 2.06% to $54.94, reflecting investor confidence in its growth potential, with analysts giving a consensus Buy rating and an average price target of $125.
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Vaxcyte Advances VAX-31 Vaccine with 95% Coverage for Adults
- Vaccine Coverage Improvement: The VAX-31 vaccine aims to provide approximately 95% protection against invasive pneumococcal disease for U.S. adults aged 50 and older, significantly enhancing vaccine efficacy to combat rising antibiotic resistance.
- Adult Clinical Progress: Vaxcyte has dosed the first participants in the OPUS-2 Phase 3 study evaluating VAX-31, with plans to enroll 1,300 participants to assess safety and immunogenicity, with results expected in the first half of 2027.
- Infant Program Advancement: Vaxcyte has completed enrollment of over 900 healthy infants in its Phase 2 dose-finding study, with preliminary safety and immunogenicity data expected by the end of the first half of 2027, further validating the vaccine's effectiveness.
- Manufacturing Expansion Strategy: Vaxcyte plans to begin building a custom fill-finish line in North Carolina in Q1 2026 as part of its $1 billion domestic manufacturing commitment, aimed at enhancing production capacity to meet future vaccine demand.
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- Stock Decline: Over the past year, Vaxcyte's stock price has plummeted by 44.2%, contrasting sharply with the S&P 500's 18.4% gain during the same period, reflecting significant market challenges and diminishing investor confidence.
- Financial Performance: The company reported a loss of $520.1 million in the first nine months of 2025 and currently has no approved products, resulting in a lack of revenue and increasing market apprehension regarding its future viability.
- Vaccine Development Strategy: Vaxcyte focuses on developing next-generation vaccines for bacterial infections, and despite current challenges, its innovative vaccine design and strategies to combat antibiotic resistance may provide a competitive edge in the future.
See More
Vaxcyte Initiates Phase 3 Trial for VAX-31 Vaccine
- Trial Launch: Vaxcyte announced the dosing of first participants in the OPUS-3 Phase 3 trial for VAX-31, a next-generation 31-valent pneumococcal conjugate vaccine aimed at enhancing immune responses against pneumococcus, which is expected to significantly improve vaccination outcomes in adults.
- Trial Scale and Design: The study will enroll approximately 720 adults aged 50 and older across 30 U.S. sites, with participants randomized to receive either VAX-31 or PCV20, assessing safety, tolerability, and immunogenicity, particularly in boosting immune responses in previously vaccinated individuals.
- Enhanced Vaccine Coverage: VAX-31 is designed to cover approximately 95% of invasive pneumococcal disease and 88% of pneumococcal pneumonia, potentially providing 14-34% broader invasive disease coverage and 19-31% broader pneumonia coverage compared to current vaccines, which may significantly reduce the incidence of related diseases.
- Future Data Expectations: Vaxcyte's broader Phase 3 adult program for VAX-31 includes OPUS-1 and OPUS-2, with key data expected in Q4 2026 and H1 2027 respectively, further advancing the vaccine's market application and Biologics License Application (BLA).
See More
Vaxcyte Prices Public Offering at $550 Million
- Offering Size: Vaxcyte announced the pricing of 11 million shares at $50.00 each, aiming for gross proceeds of $550 million, reflecting strong market confidence in its vaccine innovations.
- Underwriter Arrangement: The offering is managed by prominent financial institutions including BofA Securities and Jefferies, indicating positive market expectations for Vaxcyte's future growth and enhancing investor confidence.
- Additional Share Option: Vaxcyte granted underwriters a 30-day option to purchase an additional 1.65 million shares at the same price, a strategy that could further enhance the company's financing capabilities and support its R&D initiatives.
- Closing Timeline: The offering is expected to close on February 2, 2026, and if successful, will provide Vaxcyte with ample funding to support its vaccine development and market expansion plans.
See More
Vaxcyte Initiates Phase 3 Trials for VAX-31, Market Cap Around $7 Billion
- Vaccine Development Progress: Vaxcyte has initiated the Phase 3 OPUS-2 trial for VAX-31 in participants aged 50 and above, aiming to enroll around 1,300 individuals, showcasing the company's potential leadership in pneumococcal disease prevention.
- Manufacturing Investment: The company plans to start a custom fill-finish line in North Carolina in Q1 2026 with a $1 billion investment, enhancing its vaccine manufacturing capabilities and further solidifying its market position.
- Clinical Trial Timeline: Topline data from both OPUS-2 and OPUS-3 trials are expected in the first half of 2027, indicating Vaxcyte's strong commitment to expanding its vaccine portfolio, which could drive future revenue growth.
- Strong Market Performance: Despite mixed market conditions, Vaxcyte's stock rose 2.06% to $54.94, reflecting investor confidence in its growth potential, with analysts giving a consensus Buy rating and an average price target of $125.
See More
Vaxcyte Advances VAX-31 Vaccine with 95% Coverage for Adults
- Vaccine Coverage Improvement: The VAX-31 vaccine aims to provide approximately 95% protection against invasive pneumococcal disease for U.S. adults aged 50 and older, significantly enhancing vaccine efficacy to combat rising antibiotic resistance.
- Adult Clinical Progress: Vaxcyte has dosed the first participants in the OPUS-2 Phase 3 study evaluating VAX-31, with plans to enroll 1,300 participants to assess safety and immunogenicity, with results expected in the first half of 2027.
- Infant Program Advancement: Vaxcyte has completed enrollment of over 900 healthy infants in its Phase 2 dose-finding study, with preliminary safety and immunogenicity data expected by the end of the first half of 2027, further validating the vaccine's effectiveness.
- Manufacturing Expansion Strategy: Vaxcyte plans to begin building a custom fill-finish line in North Carolina in Q1 2026 as part of its $1 billion domestic manufacturing commitment, aimed at enhancing production capacity to meet future vaccine demand.
See More
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Stock Picks Overview: The second installment of the 2026 Barron’s Roundtable features 30 stock picks from five investment experts, highlighting both well-known companies and lesser-known options.
Familiar Names Included: Among the stock picks are recognizable brands such as Home Depot, Starbucks, and Nike, indicating a mix of established and emerging investment opportunities.
Biodegradable Innovation: The article hints at a British company that has recently acquired a manufacturer of biodegradable sneaker midsoles, showcasing a trend towards sustainable products in the footwear industry.
Investment Insights: The Roundtable serves as a platform for sharing diverse investment strategies and insights, appealing to both seasoned investors and those looking to explore new market trends.
See More
Vaxcyte CTO Sells 9,743 Shares Worth Approximately $454,891 Amidst Stock Decline
- Insider Sale: Vaxcyte's CTO Harpreet S. Dhaliwal sold 9,743 shares in an open-market transaction valued at approximately $454,891, representing 28.9% of his holdings, indicating potential concerns about the company's future performance.
- Stock Decline: Over the past year, Vaxcyte's stock price has plummeted by 44.2%, contrasting sharply with the S&P 500's 18.4% gain during the same period, reflecting significant market challenges and diminishing investor confidence.
- Financial Performance: The company reported a loss of $520.1 million in the first nine months of 2025 and currently has no approved products, resulting in a lack of revenue and increasing market apprehension regarding its future viability.
- Vaccine Development Strategy: Vaxcyte focuses on developing next-generation vaccines for bacterial infections, and despite current challenges, its innovative vaccine design and strategies to combat antibiotic resistance may provide a competitive edge in the future.
See More
