Novavax

FDA places clinical hold on Novavax's COVID-19-Influenza Combination and stand-alone influenza vaccine candidates due to a serious adverse event reported in a Phase 2 trial participant. Novavax is working with the FDA to resolve the hold and prioritize safety.

Mater Research in Brisbane has started a clinical trial for a Novavax protein-based Covid-19 and flu vaccine for individuals unable to receive mRNA vaccines. The trial, commencing on 4 November and lasting three weeks, seeks 150 healthy volunteers over 65 who haven't had a flu shot in the past two months. The trial aims to boost vaccine uptake by offering a combined option, addressing the under-vaccination against both diseases.

Four years post-COVID-19 peak, Pfizer, Moderna, and Novavax introduce new vaccines targeting strains KP.2 and JN.1. mRNA vaccines from Pfizer and Moderna differ from Novavax's traditional formula, but all aim to enhance protection against evolving COVID-19 strains. The CDC recommends updated vaccines for all over 6 months, emphasizing prevention of severe infection and death.

Novavax announces EU marketing authorization for Nuvaxovid 2024-2025 COVID-19 vaccine for ages 12+; offers protection against variants including JN.1 and KP.3; approved in the USA; common side effects include muscle aches, headaches, and nausea.

Novavax's updated 2024-2025 Nuvaxovid COVID-19 Vaccine (NVX-CoV2705) receives Marketing Authorization in the EU for individuals aged 12 and older, based on cross-reactivity data against JN.1 lineage viruses, aligning with FDA, EMA, and WHO guidance.

Novavax stock surged 19.2% to $14.68 after FDA authorized its updated COVID-19 vaccine for ages 12+ targeting JN.1 strain. The company is transitioning to an R&D model with potential partnership in 2025 and expects to meet revenue guidance for 2024/2025. Jefferies maintains a Buy rating with a $31 price target.

Every Cure adds Richard Riese, MD, PhD, as Chief Medical Officer, and Ruxandra Draghia-Akli, MD, PhD, as Chair of the Scientific Advisory Board, to advance AI-driven drug repurposing for neglected diseases.

FDA approves dupilumab for COPD, xanomeline and trospium chloride for schizophrenia, levacetylleucine for Niemann-Pick disease type C, FluMist for self-administered flu prevention, benralizumab for eosinophilic granulomatosis with polyangiitis, lebrikizumab-lbkz for atopic dermatitis, OTC hearing aid software for mild to moderate hearing loss, DaylightRX for generalized anxiety disorder, a disposable insulin patch pump for T1D and T2D, and an updated Novavax COVID-19 vaccine.

U.S. restarts free COVID test program, offering 4 free tests per household via COVIDTests.gov. Tests detect current variants and are usable through year-end. Over 900 million tests have been distributed. At-home tests provide results in 30 minutes or less, applicable to vaccinated and unvaccinated individuals. Vaccines, including mRNA and Novavax options, are also available, targeting dominant strains.