Novavax Rips Higher After Completing Regulatory Filing For Authorization Of COVID-19 Vaccine In UK

After a protracted delay, Novavax, Inc. NVAX is finally making some headway with its COVID-19 vaccine candidate – NVXCoV2373.

What Happened: Maryland-based Novavax said it has completed its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency for authorization of NVXCoV2373.

All modules required for regulatory review, including chemistry, manufacturing, control data, are now complete, the company said. The regulatory application for conditional marketing authorization for NVXCoV23673 is the first submission for authorization of a protein-based vaccine in the U.K.

"This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus," said Stanley Erck, CEO of Novavax.

Novavax expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission.

In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year.

Related Link: Merck's Oral COVID-19 Treatment Could Be Game-Changer: BofA Analyst

Why It's Important: Novavax shares came under significant pressure in late October after a report suggested the company is facing issues with the purity of its vaccine candidate.

Guidance issued by the Food and Drug Administration in June 2020 mandates each batch of vaccine should attain at least 90% purity, while Novavax has been able to show purity levels of only around 70%, the report said.

The report also raised the specter of the company's vaccine getting full licensure only by the end of 2022.

The completion of regulatory filing in the U.K. should allay investor skepticism regarding the ability of the company to bring its vaccine program to fruition.

NVAX Price Action: In premarket trading, Novavax shares were rising 14.8% to $154.97.