FDA Gives Green Signal To Novavax's COVID-19-Influenza Combo Vaccine Late-Stage Trial

On Monday, the FDA removed the clinical hold on Novavax Inc.’s NVAX Investigational New Drug (IND) application for its COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.

The FDA has cleared the company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues.

Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

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In October, the FDA issued the clinical hold due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S. who received the vaccine in January 2023.

The trial was completed in July 2023, and the participant reported the SAE in September 2024.

The FDA had requested additional information on this event. The additional information included a change in the event term to amyotrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination.

Earlier this month, Novavax and the U.K. Health Security Agency, representing the U.K. Secretary of State for Health and Social Care, signed a Termination and Settlement Agreement and an amendment to resolve disputes over their updated COVID-19 vaccine supply contract from July 1, 2022.

Novavax is scheduled to release its third-quarter earnings tomorrow, Tuesday. Data from Benzinga Pro shows a consensus estimate of $(0.83) as adjusted EPS loss and revenues of $65.8 million.

Price Action: At last check on Monday, NVAX stock was up 14.30% to $10.18 during the premarket session.

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