• Novavax (NVAX) Phase 3 Pivotal Results of RSV F Vaccine for Respiratory Syncytial Virus

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    Biotech_Forecast
    Clinical and Regulatory
    Event Type: Phase 3 Results
    Timing: Q3 2016
    Designation(s): Fast Track

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Infectious Disease
    Indication: Respiratory Syncytial Virus
    Lead Indication?: No
    Treatment Name: RSV F Vaccine

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Novavax
    Stock Symbol: NVAX
    Shares Traded: NASDAQ

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Negative
    Event Discussion: Forums
    Event Announcement(s): http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArticle&ID=2202271
    Partnership: No

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement

    Quote

    “We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality. We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results,” said  Gregory Glenn M.D ., President, Research and Development. “Historically, annual seasonal RSV ARD attack rates between 3% and 7% have been observed in older adults1. In our Phase 2 trial, we observed an RSV ARD attack rate of 4.9% and an RSV msLRTD attack rate of 1.8%. In contrast, we observed an RSV ARD attack rate of 2.0% and an msLRTD attack rate of 0.4% in our Phase 3 trial. These attack rates indicate a mild RSV season in older adults this year. We are continuing to investigate potential root causes that could have impacted the outcome of this trial. We continue to believe that there is a path forward for our RSV vaccine and that there is an important unmet need for an RSV vaccine in older adults.”

     


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