DJ Best Minds: Novavax Begins Rolling Submission for Vaccine Authorization -- Barrons.com
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The hot vaccine biotech Novavax said late Thursday that it had begun a "rolling review" of its Covid-19 vaccine with a number of regulatory agencies around the world, including the U.S. Food and Drug Administration and the European Medicines Agency, which approves drugs for European Union countries.
Novavax has begun to submit the materials required for authorization of its vaccines even as it continues to run a Phase 3 trial of its vaccine in the U.S. It is completing a Phase 3 trial in the U.K. that produced surprisingly positive interim data late last month.
The company will continue to submit materials as more data becomes available from the trials. Novavax did not say when it expects to complete submissions of its applications, or when it expects to receive authorization from the various regulators.
In a note out Thursday, Cantor Fitzgerald analyst Charles Duncan wrote that authorization in the U.S. won't come until data is available from the Phase 3 trial here. That trial is set to complete enrollment in the first half of this month, Duncan wrote.
Novavax's news came shortly before an announcement from Johnson & Johnson (JNJ) that the company had submitted its own application to the FDA for an emergency-use authorization for its Covid-19 vaccine. Johnson & Johnson's Phase 3 trial in the U.S. is already complete. The FDA said Thursday night that it had scheduled a meeting of its vaccines advisory panel for Feb. 26. Authorization of the Johnson & Johnson vaccine, if it comes, would likely arrive shortly after that date.
Shares of Novavax were up 0.5% in premarket trading on Friday. The stock is up 151.9% this year alone, and more than 4,300% over the past twelve months.
"The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide," said Novavax's president of research and development, Dr. Gregory Glenn, in a statement. "We appreciate the agencies' confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination."
Novavax reported in late January that its vaccine was 89.3% effective in its Phase 3 trial in the UK. In a separate Phase 2b trial in South Africa, where a mutant strain of the virus is predominant, the vaccine was 60% effective among HIV-negative patients.
In his note Thursday night, Cantor's Duncan, who has an Overweight rating on Novavax shares, increased his price target on the stock to $338 from $248. The stock closed Thursday at $280.92. Duncan wrote that he anticipated that the vaccine could receive emergency-use authorizations in several countries this year.
"Our [price target] increase is a result of our enhanced convicon for a differentiated clinical and logistics profile from the SARS-CoV-2 vaccine candidate," he wrote. "And the potential EUA/approval in several countries in 2021."
He wrote that he now expects the company to sell 350 million doses of the vaccine this year, which he acknowledged could be a conservative estimate.
Write to Josh Nathan-Kazis at firstname.lastname@example.org
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February 05, 2021 08:13 ET (13:13 GMT)
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