Novavax Inc. NVAX inventory is buying and selling decrease on Wednesday. The FDA has positioned a medical maintain on Novavax’s Investigational New Drug (IND) utility for its COVID-19-influenza mixture (CIC) and stand-alone influenza vaccine candidates.
The medical maintain is because of a spontaneous report of a severe hostile occasion (SAE) of motor neuropathy in a single CIC Part 2 trial participant exterior the U.S. who acquired the vaccine in January 2023.
Motor neuropathy is a situation that happens when the nerves that management motion are broken.
Additionally Learn: Some Breather For Novavax’s COVID-19 Vaccine, Inks Multibillion-Greenback Deal With Sanofi And Erases Doubts About Its Going Concern.
The trial was accomplished in July 2023, and the participant reported the SAE in September 2024.
“We’re working intently with the FDA to offer the required info that may enable them to higher perceive this statement and resolve the medical maintain,” stated Robert Walker, Chief Medical Officer, Novavax.
Knowledge from Novavax’s earlier COVID-19 and influenza trials have proven no alerts for motor neuropathy. Investigators have been knowledgeable of this motion.
The medical maintain doesn’t influence the COVID-19 IND for Novavax’s COVID-19 vaccine. In April 2022, Novavax introduced preliminary outcomes from the Part 1/2 trial of its CIC Vaccine.
The preliminary trial outcomes discovered that varied CIC vaccine formulations induced immune responses in members akin to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations.
The corporate stated that the mixture vaccine was discovered to be usually well-tolerated. Severe hostile had been uncommon, and none had been assessed as associated to the vaccine.
Final week, the European Fee authorised Novavax’s up to date 2024-2025 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, to be used in people aged 12 and older to forestall COVID-19 within the European Union.
Value Motion: NVAX inventory is down 19.10% to $10.20 throughout the premarket session eventually examine on Wednesday.
Learn Subsequent:
Photograph through Shutterstock
Market Information and Knowledge dropped at you by Benzinga APIs
© 2024 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.
