Vaxcyte Completes Enrollment in VAX-31 OPUS-1 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
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Should l Buy PCVX?
Vaxcyte announced the completion of enrollment in the VAX-31 OPUS-1 Phase 3 pivotal, noninferiority trial with approximately 4,000 participants and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine in approximately 1,300 participants.
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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: 54.670
Low
50.00
Averages
104.80
High
163.00
Current: 54.670
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.
Vera Therapeutics Appoints New Chief Legal Officer
- Executive Appointment: Vera Therapeutics has appointed Jane Wright-Mitchell as Chief Legal Officer, effective immediately, bringing extensive experience in regulatory approvals, commercialization, and intellectual property management, which will support the company as it approaches the launch of its first-in-class dual BAFF/APRIL inhibitor.
- Enhanced Legal Support: With over 25 years of legal experience in the life sciences sector, including her role as General Counsel at Vaxcyte, Wright-Mitchell's expertise is expected to strengthen Vera's legal capabilities through key milestones and the potential commercial launch of atacicept.
- Product Development Outlook: Vera's lead product candidate, atacicept, aims to treat IgA nephropathy as a subcutaneous injection administered weekly, which is anticipated to change the standard of care for patients and further enhance the company's market position in immunological diseases.
- Strategic Collaboration and Innovation: Vera Therapeutics has secured an exclusive licensing agreement with Stanford University for the development of a next-generation fusion protein targeting BAFF and APRIL, known as VT-109, showcasing the company's broad potential in treating B-cell-mediated diseases.
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Kynam Capital Reduces Stake in Cogent Biosciences by $48 Million
- Share Reduction Details: Kynam Capital disclosed in an SEC filing on February 17, 2026, that it sold 1,720,949 shares of Cogent Biosciences in Q4, with an estimated transaction value of $48.38 million, indicating a cautious approach towards the company's future prospects.
- Ownership Proportion Change: Following this sale, Cogent Biosciences now represents 13.99% of Kynam's reported AUM, yet it remains the fund's largest holding, reflecting ongoing confidence in its core investment despite the reduction.
- Market Performance Analysis: Cogent's stock price surged 360% over the past year, significantly outperforming the S&P 500's 15% gain during the same period, highlighting its strong performance and market recognition in the biotech sector.
- Future Outlook: Cogent's lead product, bezuclastinib, received FDA acceptance, with a target decision date set for December 30, 2026, and with $900.8 million in cash reserves, the company is well-positioned to support future R&D and market expansion efforts.
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Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several stocks, reflecting varying market outlooks that could influence investor decisions and market trends.
- Upgrades and Downgrades: While specific stock names are not mentioned, such rating changes typically lead to stock price volatility, prompting investors to pay close attention to these shifts for portfolio optimization.
- Market Reaction Expectations: The adjustments in analysts' ratings may trigger short-term market reactions, especially when investor sentiment towards specific stocks is sensitive, thereby impacting overall market sentiment.
- Enhanced Information Transparency: By providing a comprehensive view of analyst rating changes, investors can better understand market dynamics and make more informed investment decisions, thereby improving market transparency and efficiency.
See More
Vaxcyte Reports Q4 and Full-Year 2025 Financial Results and Business Update
- Widening Financial Losses: Vaxcyte reported a net loss of $246.5 million for Q4 2025, significantly up from $137.1 million in the same quarter last year, with a full-year net loss of $766.6 million compared to $463.9 million previously, indicating ongoing investments in R&D and operations.
- VAX-31 Clinical Progress: The company's lead 31-valent pneumococcal conjugate vaccine, VAX-31, is undergoing three pivotal Phase 3 trials, with topline data from OPUS-1 expected in Q4 2026, which will provide critical insights for its adult market launch, supported by FDA's Breakthrough Therapy Designation.
- Manufacturing Facility Development: In Q4 2025, Vaxcyte incurred an additional $21.8 million in expenditures for the construction of its dedicated Lonza manufacturing facility, bringing total expenditures to $335.4 million by year-end, with completion in Q1 2026, aimed at supporting the global commercialization of its PCV program.
- New Vaccine Candidates: Beyond VAX-31, Vaxcyte is advancing multiple vaccine candidates including VAX-24, VAX-XL, VAX-A1, and VAX-GI, showcasing the company's diversified strategy in vaccine development, particularly innovative solutions targeting various pathogens.
See More
Vaxcyte Reports Q4 Losses and Cash Position
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- Cash Position: As of December 31, 2025, Vaxcyte holds approximately $2.4 billion in cash, cash equivalents, and investments, highlighting a strong liquidity position, yet future operational expenditures remain a concern.
- Funding Initiative: The company is proposing a $500 million public offering of stock and warrants to bolster its capital structure for future R&D and operations, although market reactions may be tempered by the recent earnings miss.
- Market Impact: Following FDA officials' comments on future vaccine approvals, shares of Moderna and other vaccine makers declined, reflecting market concerns about the vaccine sector's outlook, which could have a ripple effect on Vaxcyte's stock price.
See More
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- 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
Vera Therapeutics Appoints New Chief Legal Officer
- Executive Appointment: Vera Therapeutics has appointed Jane Wright-Mitchell as Chief Legal Officer, effective immediately, bringing extensive experience in regulatory approvals, commercialization, and intellectual property management, which will support the company as it approaches the launch of its first-in-class dual BAFF/APRIL inhibitor.
- Enhanced Legal Support: With over 25 years of legal experience in the life sciences sector, including her role as General Counsel at Vaxcyte, Wright-Mitchell's expertise is expected to strengthen Vera's legal capabilities through key milestones and the potential commercial launch of atacicept.
- Product Development Outlook: Vera's lead product candidate, atacicept, aims to treat IgA nephropathy as a subcutaneous injection administered weekly, which is anticipated to change the standard of care for patients and further enhance the company's market position in immunological diseases.
- Strategic Collaboration and Innovation: Vera Therapeutics has secured an exclusive licensing agreement with Stanford University for the development of a next-generation fusion protein targeting BAFF and APRIL, known as VT-109, showcasing the company's broad potential in treating B-cell-mediated diseases.
See More
Kynam Capital Reduces Stake in Cogent Biosciences by $48 Million
- Share Reduction Details: Kynam Capital disclosed in an SEC filing on February 17, 2026, that it sold 1,720,949 shares of Cogent Biosciences in Q4, with an estimated transaction value of $48.38 million, indicating a cautious approach towards the company's future prospects.
- Ownership Proportion Change: Following this sale, Cogent Biosciences now represents 13.99% of Kynam's reported AUM, yet it remains the fund's largest holding, reflecting ongoing confidence in its core investment despite the reduction.
- Market Performance Analysis: Cogent's stock price surged 360% over the past year, significantly outperforming the S&P 500's 15% gain during the same period, highlighting its strong performance and market recognition in the biotech sector.
- Future Outlook: Cogent's lead product, bezuclastinib, received FDA acceptance, with a target decision date set for December 30, 2026, and with $900.8 million in cash reserves, the company is well-positioned to support future R&D and market expansion efforts.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several stocks, reflecting varying market outlooks that could influence investor decisions and market trends.
- Upgrades and Downgrades: While specific stock names are not mentioned, such rating changes typically lead to stock price volatility, prompting investors to pay close attention to these shifts for portfolio optimization.
- Market Reaction Expectations: The adjustments in analysts' ratings may trigger short-term market reactions, especially when investor sentiment towards specific stocks is sensitive, thereby impacting overall market sentiment.
- Enhanced Information Transparency: By providing a comprehensive view of analyst rating changes, investors can better understand market dynamics and make more informed investment decisions, thereby improving market transparency and efficiency.
See More
Vaxcyte Reports Q4 and Full-Year 2025 Financial Results and Business Update
- Widening Financial Losses: Vaxcyte reported a net loss of $246.5 million for Q4 2025, significantly up from $137.1 million in the same quarter last year, with a full-year net loss of $766.6 million compared to $463.9 million previously, indicating ongoing investments in R&D and operations.
- VAX-31 Clinical Progress: The company's lead 31-valent pneumococcal conjugate vaccine, VAX-31, is undergoing three pivotal Phase 3 trials, with topline data from OPUS-1 expected in Q4 2026, which will provide critical insights for its adult market launch, supported by FDA's Breakthrough Therapy Designation.
- Manufacturing Facility Development: In Q4 2025, Vaxcyte incurred an additional $21.8 million in expenditures for the construction of its dedicated Lonza manufacturing facility, bringing total expenditures to $335.4 million by year-end, with completion in Q1 2026, aimed at supporting the global commercialization of its PCV program.
- New Vaccine Candidates: Beyond VAX-31, Vaxcyte is advancing multiple vaccine candidates including VAX-24, VAX-XL, VAX-A1, and VAX-GI, showcasing the company's diversified strategy in vaccine development, particularly innovative solutions targeting various pathogens.
See More
Vaxcyte Reports Q4 Losses and Cash Position
- Earnings Miss: Vaxcyte reported a Q4 GAAP EPS of -$5.63, missing estimates by $4.06, indicating significant challenges in profitability that could undermine investor confidence.
- Cash Position: As of December 31, 2025, Vaxcyte holds approximately $2.4 billion in cash, cash equivalents, and investments, highlighting a strong liquidity position, yet future operational expenditures remain a concern.
- Funding Initiative: The company is proposing a $500 million public offering of stock and warrants to bolster its capital structure for future R&D and operations, although market reactions may be tempered by the recent earnings miss.
- Market Impact: Following FDA officials' comments on future vaccine approvals, shares of Moderna and other vaccine makers declined, reflecting market concerns about the vaccine sector's outlook, which could have a ripple effect on Vaxcyte's stock price.
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
