09:02 AM EST, 11/11/2024 (MT Newswires) -- Novavax ( NVAX ) said Monday that the US Food and Drug Administration has lifted a clinical hold on an investigational new-drug application for its COVID-19-Influenza combination and stand-alone flu vaccine candidates.

Novavax ( NVAX ) said the US regulator has given the company the greenlight to start enrolling in the planned late-stage trial after determining that Novavax ( NVAX ) addressed all clinical hold issues.

Novavax ( NVAX ) said it "will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible."

Shares of Novavax ( NVAX ) were up more than 12% in recent premarket activity.