December Regulatory Filing For Novavax? Novavax is on track to make a regulatory filing for approval of its coronavirus vaccine candidate NVX-CoV2373 in December, Reuters reported, citing an interview by CEO Stanley Erck gave to Czech daily Hospodarske Noviny.
Novavax is planning to produce the investigational vaccine candidate at its Czech plant, giving the nation access to the vaccine once approval comes through, Erck reportedly said.
An Ambitious Target? Novavax is evaluating the vaccine candidate in a Phase 1/2 trial and released positive interim readout from the Phase 1 portion of the trial conducted in Australia.
The company recently commenced the Phase 2 portion of the study in Australia and the U.S., with target enrollment of 1,500 volunteers.
Novavax expects to release interim immunogenicity and safety data from the trial in the fourth quarter.
The company also has an ongoing Phase 2b trial in South Africa.
Given that Novavax has yet to share any details regarding the Phase 3 trial, a December regulatory filing timeline looks tight.
That said, interim data from the Phase 2 trial holds the key as to how soon the company can go in for a regulatory filing, either for emergency use authorization or full approval.
NVAX Price Action: Novavax shares were trading down 3.81% at $110.25 at last check Thursday.