Novavax Inc. shares tumbled 11% in premarket trade Friday, after the biotech delayed its submission to the U.S. regulator for an emergency use authorization for its COVID-19 vaccine candidate.
The company said it’s now planning to seek an EUA from the Food and Drug Administration in the fourth quarter. It had earlier hoped to do so by May.
Novavax said it has filed with regulators in India, Indonesia, and the Philippines to have an emergency use authorization for the candidate, called NVX-CoV2373. The company is planning to seek an emergency use listing from the World Health Organization in August.
“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 Stanley Erck, Novavax president and chief executive, in a statement. “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.”
The company also announced its COVID-19 vaccine booster given at six months after an initial two-dose regimen increased virus-fighting antibodies by four times, and by six times for those that fought the delta variant, according to results from a recent study.
The company posted a wider-than-expected loss for the second quarter of $352.3 million, or $4.75 a share, compared with a loss of $17.5 million, or 30 cents a share, in the year-ago period.
Revenue soared to $298 million from $35.5 million in the year-ago quarter because of services performed for the U.S. government and under Coalition for Epidemic Preparedness Innovations agreements.
Analysts surveyed by FactSet, however, had forecast a loss of $3.63 a share on revenue of $387.9 million.
