Welcome to our dedicated page for Vaxcyte news (Ticker: PCVX), a resource for investors and traders seeking the latest updates and insights on Vaxcyte stock.
Vaxcyte, Inc. (Nasdaq: PCVX) is a clinical-stage vaccine innovation company focused on broad-spectrum bacterial vaccines, and its news flow reflects progress across multiple pneumococcal conjugate vaccine programs and related manufacturing and regulatory milestones. Company announcements frequently highlight clinical trial updates for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate advancing to a Phase 3 adult program and being evaluated in a Phase 2 infant study, as well as VAX-24, a 24-valent PCV candidate in a Phase 2 infant study.
Investors and observers following PCVX news can expect detailed coverage of Phase 2 and Phase 3 study designs, topline safety, tolerability and immunogenicity data, and dose-selection decisions for both adult and pediatric indications. Recent releases have described the OPUS adult Phase 3 pivotal noninferiority trial for VAX-31, the multi-stage VAX-31 infant dose-finding study, and positive topline results from the VAX-24 infant Phase 2 trial, including IgG and opsonophagocytic assay responses compared with existing PCVs.
Vaxcyte’s news also covers regulatory interactions and designations, such as the U.S. Food and Drug Administration’s Breakthrough Therapy designation for VAX-31 in adults and its expansion to include prevention of pneumonia caused by Streptococcus pneumoniae. In addition, the company reports on manufacturing and supply-chain developments, including a dedicated manufacturing suite at Lonza and a long-term agreement with Thermo Fisher Scientific’s Patheon unit to provide fill-finish capacity in Greenville, North Carolina as part of its U.S. commercial supply strategy.
Other updates include business and financial results, capital allocation priorities, early-stage pipeline decisions involving candidates such as VAX-A1 and VAX-GI, and governance changes such as board and executive appointments. For readers tracking PCVX, this news page offers an ongoing view into Vaxcyte’s clinical progress, regulatory pathway, manufacturing readiness and corporate developments around its pneumococcal and broader bacterial vaccine pipeline.
Vaxcyte (PCVX) announced the initiation of a Phase 1/2 clinical study for VAX-24, a 24-valent pneumococcal conjugate vaccine. This proof-of-concept study will assess the safety, tolerability, and immunogenicity of VAX-24 in adults, with topline results expected by the end of 2022. The study aims to prevent invasive pneumococcal disease and pneumonia, which significantly affect public health. The vaccine targets emerging serotypes not included in existing vaccines, addressing the significant morbidity and mortality associated with pneumococcal diseases.
Vaxcyte, Inc. (PCVX) will report its fourth quarter and full year 2021 financial results on February 28, 2022, after market close. The management will host a conference call at 4:30 p.m. ET to discuss these results and provide a business update. Vaxcyte is focused on developing innovative vaccines, with its lead candidate being VAX-24, a 24-valent pneumococcal conjugate vaccine aimed at preventing invasive pneumococcal disease. The company utilizes advanced synthetic techniques, including the XpressCF™ platform, to enhance vaccine efficacy and production.
Vaxcyte (Nasdaq: PCVX) announced that management will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022. The presentation is set for 2:20 p.m. ET / 11:20 a.m. PT. A live webcast will be available on the company’s website, with a replay accessible for 30 days post-conference. Vaxcyte focuses on engineering high-fidelity vaccines to combat bacterial diseases, with its lead candidate, VAX-24, aimed at preventing invasive pneumococcal disease.
Vaxcyte, Inc. (Nasdaq: PCVX) has announced a public offering of 2,500,000 shares of common stock and pre-funded warrants, priced at $20.00 and $19.999 per share, respectively. The offering is expected to generate approximately $100 million in gross proceeds, excluding the exercise of warrants. The offering is anticipated to close on January 18, 2022, subject to customary conditions. Vaxcyte has also granted underwriters a 30-day option for an additional 750,000 shares.
Vaxcyte, Inc. (Nasdaq: PCVX) announced a public offering of common stock and pre-funded warrants, with underwriters having a 30-day option to purchase an additional 15% of shares. The offering's terms are subject to market conditions and lack definitive timelines. Leading the offering are BofA Securities, Jefferies, and Evercore ISI. A shelf registration statement has been effective since July 2, 2021. The company's focus is on developing advanced vaccines, including its lead candidate, VAX-24, targeting invasive pneumococcal disease.
Vaxcyte, Inc. (Nasdaq: PCVX) announced the FDA's clearance of the Investigational New Drug application for VAX-24, its 24-valent pneumococcal conjugate vaccine. This marks a pivotal step as Vaxcyte transitions to a clinical-stage company. The Phase 1/2 clinical study is set to initiate in Q1 2022, with topline results expected by the end of the year. VAX-24 aims to address the significant public health challenge of pneumococcal disease, which affects hundreds of thousands annually in the U.S. The company is also advancing VAX-XP, designed to cover over 30 strains.
Vaxcyte, Inc. (Nasdaq: PCVX), a next-generation vaccine developer, will participate in several virtual investor conferences aimed at enhancing global health through innovative vaccine solutions. Key events include the Jefferies London Healthcare Conference from November 16-19, 2021, the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29-December 2, 2021, and the Evercore ISI 4th Annual HealthCONx Virtual Conference from November 30-December 2, 2021. Webcasts of these discussions will be available on Vaxcyte’s website for about 30 days.
Vaxcyte, Inc. (Nasdaq: PCVX) reported its Q3 2021 financials and business updates, announcing the completion of the GMP drug product manufacturing and GLP toxicology study for its VAX-24 vaccine. The company anticipates submitting the VAX-24 IND application to the FDA in Q1 2022. Q3 net loss was $26.6 million, compared to $21.0 million in Q3 2020. R&D expenses rose to $20.4 million from $16.4 million, attributed to personnel and project-related costs. Cash reserves as of September 30, 2021, were $318.3 million, down from $386.2 million at year-end 2020.
Vaxcyte, Inc. (Nasdaq: PCVX) announced the appointment of Carlos Paya as Board Chair and Michael Kamarck to its board of directors. Both leaders bring extensive experience in biopharmaceuticals and vaccine development. CEO Grant Pickering emphasized their expertise will help advance Vaxcyte’s mission to create next-generation vaccines, including the VAX-24 pneumococcal vaccine. The company aims to improve global health by developing superior vaccines targeting infectious diseases.
Vaxcyte, Inc. (Nasdaq: PCVX) announced participation in a fireside chat at the Guggenheim 2nd Annual Vaccine and Infectious Disease Conference on October 5, 2021, at 11:30 am ET. A live webcast will be available through the Company’s website, with a replay accessible for 30 days post-conference. Vaxcyte focuses on developing novel vaccines to combat infectious diseases, featuring advanced technologies like the XpressCF™ platform. Their lead candidate, VAX-24, targets invasive pneumococcal disease.
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