Shares of Novavax (NVAX 17.46%) were jumping 4.4% as of 10:59 a.m. EST on Friday after rising as much as 6.8% earlier in the day. The gain came after the biotech announced the start of a rolling review by several regulatory agencies for potential authorization of its COVID-19 vaccine candidate, NVX-CoV2373.
Today's jump appears to be warranted, with Novavax moving another step closer to potentially being able to market its COVID-19 vaccine. The company announced great interim results in late January from a U.K. phase 3 study. It makes sense that Novavax moved quickly to seek authorizations in the U.K. and other countries based on this data.
Novavax said that the European Medicines Agency, the Food and Drug Administration, the U.K. Medicines and Healthcare products Regulatory Agency, and Health Canada have started the rolling review process for Emergency Use Authorization (EUA) of NVX-CoV2373.
Perhaps the only surprise on the list is the FDA, which typically requires results from U.S. clinical trials. Novavax began a late-stage study of NVX-CoV2373 in the U.S. and Mexico near the end of 2020.
Based on the overwhelmingly positive results from Novavax's U.K. study, the chances of NVX-CoV2373 winning authorizations soon in the U.K., Europe, and Canada appear to be good. Any of these authorizations would provide a nice catalyst for the biotech stock.
It's uncertain as to whether or not the FDA can be convinced to allow Novavax to use its British data for an EUA filing in the U.S., though. Novavax might have to wait a few months before it can launch NVX-CoV2373 in the states.