Vaxcyte Updates on VAX-31 Progress, Plans BLA Submission in H1 2027
Vaxcyte provided updates on the continued advancement of VAX-31, the company's next-generation 31-valent pneumococcal conjugate vaccine, or PCV, candidate, across its adult and infant clinical programs. For the VAX-31 adult indication, the first participants have been dosed in a Phase 3 trial evaluating VAX-31 when administered concomitantly with a licensed seasonal influenza vaccine in pneumococcal-naive adults aged 50 years and older - the OPUS-2 trial. Additionally, Vaxcyte plans to initiate a separate Phase 3 trial in Q1 evaluating VAX-31 in adults who have previously received a pneumococcal vaccine - the OPUS-3 trial -. For the VAX-31 infant indication, the company has completed enrollment in its Phase 2 dose-finding study evaluating VAX-31 in healthy infants. Vaxcyte expects to report topline safety, tolerability and immunogenicity data from both OPUS-2 and OPUS-3 Phase 3 studies in the first half of 2027, supporting planned BLA submission. Topline OPUS-1 data is expected in Q4. The VAX-31 Adult Phase 3 clinical studies were designed in consultation and alignment with the FDA. As for the VAX-31 infant indication, Vaxcyte completed enrollment of its Phase 2 dose-finding study evaluating VAX-31 for prevention of invasive pneumococcal disease and expects to announce topline data from primary immunization series and booster Dose either sequentially or together by the end of the first half of 2027.
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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.
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.
