Novavax Withers as Hopes Grow for FDA Nod

Novavax Inc’s (NASDAQ: NVAX) COVID-19 shot can probably win U.S. Food and Drug Administration (FDA) emergency use nod as early as May.

CEO Stanley Erck hailed the news this week.

Dubbed NVX-CoV2373, its recombinant protein-based vaccine candidate against COVID-19 is still undergoing Phase 3 study (PREVENT-19) in the U.S. with 30,000 participants.

In late January, Novavax released Phase 3 trial results in the U.K., showing the vaccine was 89.3% effective overall, though slightly less effective against the variant strains found in the U.K. and South Africa.

Erck also said the company hopes the FDA will allow it to use data from its clinical trial conducted in the U.K. when it files its emergency use application later this year.

"U.K. health regulators will potentially review the vaccine in April, followed by the FDA, probably a month after that. This timeline could move back by a month or two if the agency chooses to wait for the U.S.-based trial data."

Novavax has agreed to supply 110 million doses to the U.S. government, and the shipments are expected to complete around June or July.

Monday, the company reported financial figures, showing Novavax reported a net loss of $177.6 million, or $2.70 per share, for the fourth quarter of 2020, compared to a net loss of $31.8 million, or $1.13/share last year. The company, however posted fourth-quarter revenue of $279.66 million, compared with $8.8 million last year.

NVAX shares dumped $24.05, or 10%, early Tuesday to $216.24.