By Bhanvi Satija
(Reuters) -Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full approval, sending the drugmaker’s shares soaring and easing concerns around the future of the shot.
Shares gained nearly 20% to $7.48 on Wednesday after the request, which Novavax (NASDAQ: NVAX ) said it would address promptly so it "move to approval as soon as possible."
The vaccine’s prospects were thrown into doubt after the U.S. Food and Drug Administration missed its April 1 deadline to approve the shot and U.S. Health and Human Services secretary Robert F. Kennedy Jr. attributed the delay to the shot’s composition in a CBS interview earlier this month.
The company wants to convert the vaccine’s emergency authorization dating to 2022 into a full approval that would allow for expanded use and to compete better against messenger RNA shots from rivals Moderna (NASDAQ: MRNA ) and Pfizer-BioNTech.
Post-marketing commitments are studies or clinical trials that a company agrees to conduct after a vaccine or drug is approved, to further test their safety or optimal use. The FDA’s request comes during a period of mass layoffs, including of high-ranking scientists, as part of a major overhaul under Kennedy that has prompted concerns that the regulatory review of treatments and vaccines could be disrupted.
"I think the odds for approval went up quite a bit," B Riley analyst Mayank Mamtani said in an interview, adding that Wednesday’s request from the FDA gave investors clarity on the path to approval in light of comments from Kennedy, a longtime vaccine critic.
Mamtani and at least one other analyst said they were confident that the vaccine would ultimately be approved. They said the next steps for the company would be to finalize the details of the post-marketing study along with the FDA.
At least two analysts said such studies were very common.
Novavax’s protein-based technology offers an alternative to mRNA vaccines from Pfizer-BioNTech and Moderna, which received full approvals in 2021 and 2022, respectively.
The biotech had raised doubts about its ability to remain in business in 2023, hurt by manufacturing snags and regulatory hurdles that delayed the entry of its protein-based vaccine to the market. The stock has been volatile for much of its existence, gaining nearly 2,400% in 2020 when the COVID-19 pandemic hit, only to lose more than 95% of its value in the three years following.
It removed its "going concern" notice last year after it struck a licensing deal worth at least $1.2 billion with Sanofi (NASDAQ: SNY ). Since that deal was announced, shares have gained 65%.
A full approval would trigger a milestone payment to Novavax from Sanofi and allow the companies to market the vaccine.