FDA Lifts Clinical Hold On Novavax COVID-19-Influenza Combo Vaccine Candidate; Stock Up

(RTTNews) - Novavax, Inc. (NVAX) 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 clinical hold was placed when a Phase 2 study participant, who received the company's CIC vaccine candidate, reported a serious adverse event (SAE) of motor neuropathy in September this year. The Phase 2 study was completed in 2023.

"The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible," said Robert Walker, Chief Medical Officer, Novavax.

Novavax stock had closed at $8.91, down 2.94 percent on Friday. It has traded in the range of $3.53 - $23.86 in the last 1 year.