Vaxcyte Incorporated (NASDAQ:PCVX) is one of the 17 biotechnology stocks with more than 50% upside. On January 23, Cantor Fitzgerald maintained its Overweight rating on Vaxcyte Incorporated (NASDAQ:PCVX), highlighting continued progress across the company’s clinical pipeline. The firm reflected on the topline readout from the Phase 3 OPUS-1 trial, expected in the fourth quarter of 2026, with a planned BLA filing the following year. OPUS-2 has already begun participant dosages, and OPUS-3 is set to start i ...

Summary of Vaxcyte Conference Call Company Overview - **Company**: Vaxcyte - **Focus**: Development of pneumococcal conjugate vaccines, particularly the VAX-31 program Key Industry Insights - **Vaccine Market**: The pneumococcal conjugate vaccine segment is currently valued at **$8 billion** and is expected to grow significantly as adult vaccination rates increase, similar to those of children [3][8] - **Market Dynamics**: The market has seen a shift with increasing recommendations for adult vaccinations outside the U.S., leading to growth opportunities in global markets [8][9] Core Product Insights - **VAX-31 Program**: - A **31-valent** vaccine that aims to provide broader coverage than existing vaccines, which are limited to **20 or 21 serotypes** [6][12] - Phase 2 data showed improved immune responses while expanding coverage, leading to confidence in Phase 3 trials [12][20] - The pivotal study, OPUS 1, will involve **4,000 subjects** aged 50 and older, comparing VAX-31 to current standard vaccines [13][34] Competitive Landscape - **Current Competitors**: - **Prevnar 20**: Market leader with a focus on older serotypes - **CAPVAXIVE**: A newer entrant with broader coverage of circulating serotypes [22][24] - **Market Positioning**: Vaxcyte aims to position VAX-31 as a superior option by covering both older and newer serotypes, potentially capturing significant market share as the market evolves [23][24] Regulatory and Commercial Strategy - **Regulatory Environment**: Vaxcyte is working closely with the FDA to ensure that the Phase 3 program meets higher standards for non-inferiority, reflecting a shift in regulatory expectations [14][19] - **Commercial Strategy**: The company plans to be selective in its commercialization approach, potentially partnering in certain markets while pursuing direct sales in others [10][11] Financial Position - **Funding**: Vaxcyte recently raised over **$3 billion** in cash, providing a strong financial position to support upcoming milestones, including the potential approval and launch of VAX-31 in **2028** [61] Additional Insights - **Catch-Up Vaccination**: There is a significant opportunity for catch-up vaccinations for adults who have previously received older vaccines, which could expand the market further [43][44] - **Pediatric Program**: Vaxcyte is also developing a pediatric version of the vaccine, with expectations for Phase 2 data in the near future [52][56] - **Otitis Media Opportunity**: VAX-31 has the potential to significantly reduce cases of acute otitis media in children, which is often caused by pneumococcal infections [58][59] Conclusion Vaxcyte is positioned to capitalize on the growing pneumococcal vaccine market with its innovative VAX-31 program, backed by strong financial resources and a strategic approach to commercialization and regulatory compliance. The company aims to address both adult and pediatric markets, with a focus on broadening vaccine coverage and improving health outcomes.

Company Expects to Report Topline Data from OPUS-3 Trial and OPUS-2 Phase 3 Trial Evaluating Concomitant Administration of VAX-31 and a Seasonal Influenza Vaccine in First Half of 2027 OPUS-1, VAX-31 Adult Phase 3 Noninferiority Trial, Continues to Enroll Subjects, with Topline Data Expected in Fourth Quarter of 2026 Vaxcyte’s VAX-31 Phase 3 Adult Clinical Program – Finalized in Consultation and Alignment with U.S. Food and Drug Administration – to Support Planned BLA Submission VAX-31 is Designed to Cove ...

SAN CARLOS, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, announced today that it will report financial results for the fourth quarter and full year 2025 and provide a business update after market close on February 24, 2026. Company management will host a conference call and webcast beginning at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial 800-445-7795 (domestic) or 785-424-1699 (international), confere ...

SAN CARLOS, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced that Company management will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit in New York on Thursday, February 12, 2026 at 1:30 p.m. ET / 10:30 a.m. PT. A live webcast of the fireside chat can be accessed through the Investors & Media section of the Company’s website at http://investors.vaxcyte.com. A replay of the webcast will be ...

Core Viewpoint - Vaxcyte, Inc. has successfully closed a public offering of 12,650,000 shares of common stock at a price of $50.00 per share, raising a total of $632.5 million in gross proceeds before expenses [1]. Group 1: Offering Details - The offering included the full exercise of an option by underwriters to purchase an additional 1,650,000 shares [1]. - The joint book-running managers for the offering were BofA Securities, Jefferies, Leerink Partners, Evercore ISI, and Guggenheim Securities, with Mizuho acting as a book-runner [2]. Group 2: Regulatory Information - A shelf registration statement for the offered securities was filed with the SEC and became effective on May 24, 2024 [3]. - A final prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available on their website [3]. Group 3: Company Overview - Vaxcyte is focused on developing high-fidelity vaccines to combat bacterial diseases, with notable candidates including VAX-31 and VAX-24, which are designed to prevent invasive pneumococcal disease [5]. - The company utilizes the XpressCF® cell-free protein synthesis platform to enhance the development of complex vaccines [6]. - Vaxcyte's pipeline also includes vaccine candidates for Group A Strep infections and Shigella [6].

Core Viewpoint - Vaxcyte, Inc. has announced a public offering of common stock, aiming to raise $550 million through the sale of 11 million shares at a price of $50.00 per share, with an option for underwriters to purchase an additional 1.65 million shares [1][2]. Group 1: Offering Details - The public offering is expected to close on February 2, 2026, pending customary closing conditions [2]. - The offering is managed by several financial institutions, including BofA Securities, Jefferies, and Guggenheim Securities, among others [2]. Group 2: Company Overview - Vaxcyte is focused on developing high-fidelity vaccines to combat bacterial diseases, with notable candidates including VAX-31 and VAX-24, which are designed to prevent invasive pneumococcal disease [5][6]. - The company utilizes a proprietary cell-free protein synthesis platform, XpressCF®, to enhance the development of complex vaccines [6]. Group 3: Pipeline and Innovation - Vaxcyte's pipeline includes VAX-A1, aimed at preventing Group A Strep infections, and VAX-GI, designed to prevent Shigella [6]. - The company is innovating vaccine production methods to improve immunological benefits and expand coverage against various serotypes [5][6].

Vaxcyte Inc. (NASDAQ:PCVX) is one of the best US stocks to buy under $50. On January 23, Cantor Fitzgerald reaffirmed its Overweight rating on Vaxcyte Inc. (NASDAQ:PCVX), keeping a positive view as the company advances its vaccine pipeline on schedule. The firm expects topline results from the Phase 3 OPUS-1 trial in late 2026, with an adult BLA filing planned for 2027. Evercore ISI Rates Vaxcyte Inc. (PCVX) as an Overweight Following CDC Changes to Childhood Vaccination Recommendations It also noted pro ...

Core Insights - Vaxcyte has initiated dosing of the first participants in a Phase 3 study for VAX-31, a 31-valent pneumococcal conjugate vaccine, evaluating its administration alongside a seasonal influenza vaccine in adults aged 50 and older [1][3] - The company plans to start another Phase 3 trial (OPUS-3) in early 2026 for adults previously vaccinated with pneumococcal vaccines [1][3] - Vaxcyte expects to report topline safety, tolerability, and immunogenicity data from both OPUS-2 and OPUS-3 studies in the first half of 2027, supporting a planned Biologics License Application (BLA) submission [1][4] VAX-31 Adult Indication - The OPUS-2 trial will enroll approximately 1,300 participants and is designed to evaluate the safety, tolerability, and immunogenicity of VAX-31 when administered with a seasonal influenza vaccine [7][10] - The OPUS-3 trial will involve around 720 adults with a history of prior pneumococcal vaccination, assessing the safety and immunogenicity of VAX-31 [10][12] - A total of approximately 6,000 adults are expected to be enrolled across the adult Phase 3 studies, with about 3,400 receiving VAX-31 [6][5] VAX-31 Infant Indication - Vaxcyte has completed enrollment of 905 healthy infants in a Phase 2 dose-finding study for VAX-31, which aims to expand coverage against pneumococcal disease [14][19] - The vaccine is designed to increase protection against invasive pneumococcal disease (IPD) from approximately 69% to 92% in children under five years of age [14][21] - Topline data from the infant study is expected by the end of the first half of 2027 [19] Manufacturing and Commercial Supply Chain - The company plans to initiate the buildout of a custom fill-finish line in North Carolina in early 2026, as part of a long-term commitment of up to $1 billion in U.S. manufacturing and services [2][15] - Vaxcyte is establishing a dedicated local presence in North Carolina, focusing on chemistry, manufacturing, and controls (CMC) activities [15][2] Anticipated Key Milestones - The OPUS-3 Phase 3 trial is set to begin in the first quarter of 2026 [18] - Topline data from the OPUS-1 trial is expected in the fourth quarter of 2026 [18] - Data from the OPUS-2 and OPUS-3 trials will be announced in the first half of 2027 [18][19]

Company Overview - Vaxcyte is a clinical-stage biotechnology company focused on developing next-generation protein vaccines to meet unmet medical needs in bacterial infectious disease prevention [2] - The company's pipeline includes vaccines such as VAX-24 for pneumococcal disease, VAX-XP for emerging strains, VAX-A1 for Group A Strep, and VAX-PG for periodontitis [1][2] - Vaxcyte employs advanced conjugation and protein engineering technologies to enhance vaccine coverage and combat antibiotic resistance [2] Recent Insider Activity - Harpreet S. Dhaliwal, Chief Technical Ops Officer of Vaxcyte, sold 9,743 shares in an open-market transaction valued at approximately $454,891, reducing his direct ownership by 28.9% [4][5] - Following this sale, Dhaliwal's stake decreased from 33,671 shares to 23,928 shares, with no remaining indirect exposure [3][4] Stock Performance - Vaxcyte's stock price has declined by 44.2% over the past year, contrasting with an 18.4% return from the S&P 500 index during the same period [5] - The company's shares experienced a significant drop in late March and early April, followed by a modest recovery, which raises concerns about the sustainability of this momentum [6] Financial Performance - Vaxcyte does not have any approved products on the market, resulting in no revenue generation [6] - The company reported a loss of $520.1 million during the first nine months of 2025 [6] Future Outlook - Monitoring the approval process for Vaxcyte's vaccines will be crucial for assessing the company's future success [7] - Insider transactions, such as those by Dhaliwal, may provide insights into the confidence of company leadership regarding product approvals [7]