Shares of Novavax (NVAX -4.10%) were 6.3% higher as of 10:56 a.m. EST on Monday after rising as much as 9.7% earlier in the day. This nice gain came after the biotech updated the progress of its COVID-19 vaccine development before the market opened.
Novavax stated that its late-stage study in the U.K. and its phase 2b study in South Africa of coronavirus vaccine candidate NVX-CoV2373 had completed enrollment. The company also said that its U.S./Mexico late-stage study is "expected to begin in the coming weeks." Novavax had previously stated this study would begin in November.
You might have thought that the biotech stock would fall after announcing a delay with its late-stage U.S. study of NVX-CoV2373. And that's exactly what happened initially. Novavax's shares fell by nearly 6% earlier on Monday morning. But that loss was reversed as investors considered the bigger picture for the company.
A delay of a few weeks in the initiation of the U.S./Mexico late-stage study shouldn't matter all that much if NVX-CoV2373 proves to be safe and effective. At this point, there aren't any red flags to cause concerns.
Investors also likely recognized the importance of the good news announced by Novavax today. The company expects to report interim data from the U.K. late-stage study of NVX-CoV2373 as soon as early in the first quarter of 2021. While the exact timing of this report depends on the overall COVID-19 rate in the U.K., cases have been increasing in the region, which should bode well for an announcement sooner rather than later.
The next major milestone for Novavax will be the start of its U.S./Mexico late-stage study of NVX-CoV2373. It sounds like this study could begin in December, although the decision rests with the Food and Drug Administration. Novavax said that more than 100 trial sites in the U.S. and Mexico have already been selected.