(Bloomberg) — The upcoming release of Novavax Inc.’s Covid-19 vaccine trial results may not only help provide additional pandemic relief across the globe, it could also validate investor support that buoyed the stock by 1,190% over the past year.
The biotech firm said in March its shot could get cleared by the Food and Drug Administration for emergency use as early as May. To hit its May target, Novavax may need to submit data to the FDA within the next week or so. It may take regulators then several weeks to review the results and decide on whether to grant an authorization, based on timelines of previous U.S. Covid-19 vaccine clearances.
If that materializes, the company will have the fourth Covid-19 vaccine in the U.S. in addition to shots from Pfizer Inc. with its German partner BioNTech SE, Moderna Inc. and Johnson & Johnson.
Novavax representatives declined to comment on the upcoming results and timeline for the release of trial data.
Novavax may have lost the race on vaccinating millions of Americans with more than 230 million doses administered stateside but a successful trial can still help developing nations like India and Brazil where shots are in high demand as infections hit record levels. U.S. President Joe Biden said Tuesday that upcoming vaccines, including one from Novavax, could be shared with other countries.
Novavax’s shares skyrocketed last summer when it became one of the front-runners in the race to develop an inoculation against the coronavirus. But it has since trailed behind U.S. market leaders both on production and on a valuation standpoint.
Moderna, which secured an emergency authorization in December, now trades at roughly four times Novavax’s market value of about $17.6 billion, while Germany’s BioNTech is worth $43 billion. CureVac N.V., another vaccine hopeful that’s also been buoyed by its ties to Tesla Inc., has a valuation of about $21 billion.
Encouraging Outlook
Vaccine results outside of the U.S. have shown promise. In a 15,000 person U.K. trial, Novavax’s shot demonstrated 89.7% effectiveness in preventing symptoms of the disease. And with the rise of resistant variants, the bar for the upcoming North American trial has been set lower, where 80% effectiveness would be a “home run,” according to Sam Fazeli, a Bloomberg Intelligence analyst.
“What’s very encouraging is the efficacy of 96.4% versus the previous versions of the virus and 86.3% against the U.K.-prevalent B.1.1.7 variant — 57% of infections in the trial. There were five cases of severe Covid-19 in the final analysis, suggesting the vaccine has 100% efficacy similar to other vaccines being rolled out, which is not surprising given its success against milder disease,” Fazeli said.
Novavax fell 2.8% to $237.53 on Thursday, after closing at a high of $319.93 in early February. The shares had six buy ratings, one hold and zero sell recommendations among analysts tracked by Bloomberg.
Expectations for further gains in the stock has added pressure on short sellers who have more than $1.1 billion worth of outstanding bets against the company as of April 29, according to S3 Partners data. So far this year Novavax short sellers have lost more than $800 million, according to Ihor Dusaniwsky, S3’s managing director of predictive analytics.
“Price strength will probably force even more shorts out of their positions,” Dusaniwsky said in an interview.
(Updates with closing share price moves throughout.)
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