The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its standalone flu vaccines after a safety concern was found to be unrelated to the combination shot,

Novavax is already poised to benefit from a separate combined Covid-flu vaccine via a deal with Sanofi announed earlier this year. Under the $1.4 billion co-licensing agreement, announced in May, Sanofi will have the sole right to use Novavax's existing Covid-19 vaccine in combination with its own flu vaccine.

Novavax (NASDAQ:NVAX) shares climbed 12% premarket on Monday after the U.S. FDA lifted clinical hold on the investigational new drug application for the pharma firm’s COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.

Monday said the Food and Drug Administration or FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. Novavax shares were up more than 13 percent in pre-market.

The U.S. Food and Drug Administration (FDA) has lifted its hold on a late-stage trial for Novavax’s COVID-influenza combination and standalone flu vaccines, the company reported on Monday (NASDAQ:MNDY).