- Novavax (NVAX +44.4%) is up on almost 5x higher volume on the heels of its announcement of encouraging developments in a Phase 3 clinical trial assessing the effectiveness of its RSV F vaccine in newborns by immunizing mothers. The information was part of a corporate presentation delivered at JPM18.
- The primary endpoint of the study is the incidence of RSV lower respiratory tract infection. In order to inform on further investment in the program, the company conducted an informational analysis based on a target efficacy threshold of at least 40% at day 90. The analysis showed that the observed efficacy should be 45 - 100%. It also concluded that the medically significant secondary endpoints (e.g., hospitalizations, more severe RSV infections) would likely exceed the threshold for vaccine efficacy.
- A Data Safety Monitoring Board statistician communicated to the company that the vaccine successfully met these criteria based in an analysis of unblinded data (company remains blinded).
- Enrollment efforts have been ramped up in order to accelerate the timing of the interim data readout, expected by Q4 2018/Q1 2019. If positive, a U.S. marketing application could be filed by late 2019. If approved, it will be the only game in town. Management sees global peak sales of at least $1.5B ($750M in U.S.).
- #JPM18
- Now read: Watch These December Biotech Catalysts: A Retrospective
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