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Tag: PCVX stock

  • Vaxcyte (PCVX) Shares Surge In Pre-Market On The Back of Promising Study Findings

    Vaxcyte (PCVX) Shares Surge In Pre-Market On The Back of Promising Study Findings

    Vaxcyte, Inc. (NASDAQ: PCVX) is seeing a significant rise in its shares this morning, climbing 35.85% to $109.71 during the pre-market session. This increase comes after the PCVX revealed positive topline results from a recent Phase 1/2 clinical research.

    Vaxcyte Reported Encouraging Research Results for VAX-31

    Vaxcyte has released positive topline findings from a Phase 1/2 study assessing the immunogenicity, safety, and tolerability of VAX-31, a 31-valent pneumococcal conjugate vaccine. The vaccine was tested on 1,015 healthy adults 50 years of age and older with the goal of preventing invasive pneumococcal disease (IPD). Based on compelling evidence, Vaxcyte has chosen to proceed with VAX-31’s development to a Phase 3 adult investigation.

    In the Phase 1/2 study, VAX-31 demonstrated a safety profile comparable to Prevnar 20 (PCV20) across all doses examined. The vaccine exhibited strong opsonophagocytic activity (OPA) immune responses for all 31 serotypes at each dose level. Notably, VAX-31 met or surpassed the non-inferiority criteria for OPA responses in all 20 serotypes common with PCV20 at the middle and high doses.

    PCVX Observed Impressive Immune Response

    At the middle dose, VAX-31 showed a geometric mean ratio (GMR) exceeding 1.0 for 13 of the 20 serotypes and achieved statistically superior immune responses for five of these serotypes compared to PCV20. For the 11 additional serotypes unique to VAX-31, all three dose levels met the superiority criteria. Vaxcyte intends to finalize the VAX-31 dose selection before starting the adult Phase 3 program.

    Future Plans and Public Health Impact

    The encouraging results from the Phase 1/2 study underscore Vaxcyte’s site-specific, carrier- The high case-fatality rates, antibiotic resistance, and meningitis associated with IPD might meet the public health demand for increased prevention. By mid-2025, Vaxcyte intends to start the major Phase 3 investigation for VAX-31; topline data are anticipated in 2026.

    PCVX business will proceed with more Phase 3 trials and file a biologics license application pending these results. VAX-31 is anticipated to significantly improve coverage against more than 95% of circulating IPD strains in adults 50 and older, potentially setting a new standard in pneumococcal vaccination.

  • $100M Public Offering: Vaxcyte Inc. (PCVX) stock Plummets Deep Pre-Market

    $100M Public Offering: Vaxcyte Inc. (PCVX) stock Plummets Deep Pre-Market

    On January 13, Vaxcyte Inc. (PCVX) announced the pricing of a $100 million public offering of its common stock shares.

    In the previous market session, PCVX stock lost 6.28% at its closing price of $22.00 on Wednesday. The stock plunged further pre-market to reach $20.18 with a loss of 8.27%.

    Founded in 2013, the high-fidelity vaccine developer, Vaxcyte Inc. is headquartered in Foster City, CA. Currently, its 52.79 million outstanding shares trade at a market capitalization of $1.25 billion. Moreover, the stock has subtracted 7.99% in the past five days, while losing 14.73% last year.

    PCVX’s Public Offering

    According to today’s announcement, the company has offered 2,500,000 shares of its common stock along with pre-funded warrants in an underwritten public offering. Furthermore, the public offering price of its common stock shares is $20.00/share and the pre-funded warrants are $19.999 per underlying share.

    Excluding the exercise of pre-funded warrants, the expected gross proceeds from the offering are $100.0 million, less discounts and commissions.

    In addition, a 30-day option for buying additional 750,000 common stock shares has also been granted by PCVX to the underwriters. Further, the per-share price of the additional common stock shares will be the same as the original public offering.

    Subject to customary closing conditions, the expected close of the offering is on January 18, 2022.

    Finally, the joint book-running managers for the offering are BofA Securities and Evercore ISI. Added to this, the acting co-manager for the offering is Needham & Company.

    IND Clearance for VAX-24

    VAX-24 is the company’s lead broad-spectrum PCV (pneumococcal conjugate vaccine) candidate for the prevention of invasive pneumococcal disease (IPD).

    On January 06, the company announced receiving Investigational New Drug application clearance for VAX-24. Consequently, PCVX expects to commence the Phase ½ clinical proof-of-concept study of VAX-24 in the first quarter of 2022. The trial will evaluate the safety, tolerability, and immunogenicity of the vaccines in healthy adults. Additionally, the topline immunogenicity results are expected by the end of 2022.

    PCVX in Numbers

    The company declared its financial results for the third quarter of 2021 on November 10.

    In the third quarter of 2021, PCVX had a net loss of $26.6 million, against $21.0 million in the year-ago quarter.

    The company ended the quarter with cash, cash equivalents, and investments of $318.3 million on September 30, 2021.