What happened
Shares of Novavax (NVAX 8.12%) jumped 22.8% in August, according to data provided by S&P Global Market Intelligence. This came after Novavax reported clinical trial progress for its vaccine ResVax during the company's second-quarter earnings report.
So what
Novavax reached an agreement with the Food and Drug Administration: The readout of a clinical trial testing ResVax, the company's vaccine against respiratory syncytial virus (RSV) in pregnant women, could be used to get the vaccine approved. The trial is designed to show that the vaccine can immunize infants to RSV while still in utero.
The company was previously guiding that the analysis, scheduled for the first quarter of 2019, would be an interim look at the data -- so the agency signing off on it being a final analysis will accelerate a potential approval. If the data are positive, Novavax plans to submit to the FDA and to European regulators in the first quarter of 2020.
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Novavax is also making progress on its influenza vaccine, NanoFlu. The FDA agreed that the company can take an accelerated approval route by comparing the immunogenicity -- the ability to create antibodies -- of its vaccine to already-approved vaccines. The strategy would allow Novavax to run a trial in the second half of 2019, potentially submitting the data around the same time as ResVax is submitted.
Now what
The regulatory updates last month are certainly good news for Novavax. But they don't really reduce the risk of investing in the biotech, since Novavax still needs to produce positive clinical trial data in order to take advantage of the new rules. Fortunately investors won't have to wait too much longer, with clinical trial data for both products expected in four to seven months.
