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Novavax Stock Slumps Amid Delays in Seeking FDA COVID Vaccine Approval

Novavax says it expects to seek EUA approval from the Food and Drug Administration for its coronavirus vaccine candidate 'in the fourth quarter of 2021.'

Novavax  (NVAX) - Get Free Report shares slumped lower Friday after the drugmaker posted a wider-than-expected second quarter loss and said it would delay its application for emergency approval of its developing coronavirus vaccine until the end of the year.

The Gaithersburg, Maryland-based drugmaker said it expects to seek regulatory approval from the U.S. Food & Drug Administration for its NVX-CoV2373 coronavirus vaccine candidate in the fourth quarter -- a few months behind its prior estimate -- but noted that it remains on track to reach manufacturing capacity of 100 million doses per month by October and 150 million does per month by the end of the year. 

Novavax also posted a second quarter loss of $4.75 per share after the close of trading Thursday, on revenues of $298 million, both of which missed analysts' forecasts. 

"We are highly encouraged by the filing of regulatory submissions in multiple markets (and) we view these submissions as the first of many filings to come, which will allow NVX-CoV2373 to be made available at a global scale," said CEO Stanley Erck. "Our clinical successes over the second quarter reaffirm our confidence in NVX-CoV2373's differentiated efficacy profile."

"We continue to see the circulation of new variants and inequitable access to vaccine globally, demanding that we bring our COVID-19 vaccine to market as swiftly as possible," Erck said, before later telling investors on a conference call that sales could be prioritized to low-income countries.

Novavax shares were marked 17.8% lower in early trading Friday to change hands at $195.00 each, a move that would still leave the stock with a year-to-date gain of around 80%.

Earlier this spring, Novavax said NVX-CoV2373 hit a 90.4% efficacy rate in a trial of nearly 30,000 participants, with a 100% protection rate against moderate and severe forms of COVID 19. Its efficacy rate against 'predominantly circulating' variants, Novavax said, was around 93%.

Last night, Novavax said a booster shot delivered six-month after the second of its two-dose regime induced a 4.6 fold increase in COVID antibodies.