Shares of Novavax (NVAX 2.82%) were jumping 8.2% higher as of 12:16 p.m. EDT on Tuesday. Two factors were likely behind the solid gain. Novavax announced the formation of a leadership team to guide its influenza vaccine candidate NanoFlu through the regulatory licensing process and explore the potential for a combined influenza/COVID-19 vaccine. Also, Johnson & Johnson temporarily paused its late-stage clinical study evaluating COVID-19 vaccine candidate JNJ-78436735.
Novavax is one of only a handful of drugmakers with coronavirus vaccine candidates in late-stage testing. If J&J's COVID-19 vaccine is found to have safety problems, it could translate to a bigger market opportunity for Novavax's NVX-CoV2373. However, it's way too soon to think that J&J's pause will be anything but temporary.
Investors are probably more excited about positive steps in the road to approval for NanoFlu. The company promoted Russell Wilson to executive vice president and the newly created position of NanoFlu general manager. Wilson said he has "a strong sense of urgency" to guide NanoFlu to FDA approval.
There's also undoubtedly some eagerness about the prospect that NanoFlu could be combined with NVX-CoV2373 into a combo flu/COVID-19 vaccine. Novavax thinks a combo vaccine could be promising for use after the current pandemic ends.
Novavax has already initiated a phase 3 study of NVX-CoV2373 in the U.K. The next potential catalyst for the biotech stock will likely be the start-up of a late-stage study of the COVID-19 vaccine candidate in the U.S., which could happen as soon as this month. Novavax didn't provide any details on how soon it will submit for FDA approval of NanoFlu.