Novavax Inc said on Monday it was on track to begin a delayed U.S.-based late-stage study of its experimental coronavirus vaccine later this month.
The company also said the vaccine, NVX-CoV2373, had gained the U.S. Food and Drug Administration’s “fast-track” status and that expected data from the trial could support U.S. authorization and approval.
Novavax, which is testing the drug in a late-stage study in the UK, last month postponed the start of the U.S. trial by roughly a month, due to delays in scaling up the manufacturing process.
A handful of companies are testing their experimental coronavirus shots in late-stage studies, and Pfizer Inc said on Monday its experimental COVID-19 vaccine was more than 90% effective, citing early data from a large-scale clinical trial.
A fast-track status allows companies to submit sections of a marketing application on a “rolling” basis as soon as some data becomes available, rather than wait for all the data before submitting the application.
Novavax is scheduled to report its quarterly results later on Monday.
The company’s shares were up nearly 8% at $97 before the bell, reversing from a fall earlier.