Novavax Inc - NVAX STOCK NEWS

Novavax (NVAX) has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza vaccines. The trial will evaluate immunogenicity and safety in adults aged 65 and older, comparing the candidates to Novavax's updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine.

The initial trial cohort includes approximately 2,000 participants, with more clarity on potential next steps expected by Q2 2025. The company is working with the FDA to explore an accelerated approval pathway and intends to seek strategic partnerships for filing and commercialization. The financial guidance for FY 2025 includes R&D and SG&A expenses of approximately $500 million for this clinical activity.

Novavax (NVAX) has announced the sale of its manufacturing facility in Bohumil, Czech Republic, to Novo Nordisk for $200 million. The deal includes a 150,000-square foot recombinant protein manufacturing facility with support buildings, workforce, and infrastructure.

The transaction will provide Novavax with $190 million in cash payment in 2024 and an additional $10 million in 2025. The company expects to achieve annual operating cost reductions of approximately $80 million. This non-dilutive capital will support Novavax's corporate growth strategy focused on developing its pipeline assets and technology platform, including Matrix-M adjuvant and nanoparticle protein-based technology.

Novavax (NVAX) has granted inducement awards to its newly appointed Executive Vice President and Head of Research & Development, Dr. Ruxandra Draghia-Akli. The awards include a non-qualified stock option to purchase 64,150 shares at $9.01 per share and restricted stock units for 42,770 shares. The stock option will vest 25% after one year, with remaining shares vesting monthly over 36 months. The restricted stock units will vest in three equal annual installments. Both awards are subject to continued employment and were granted under the Novavax 2023 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

Novavax (NVAX) has announced its participation in the upcoming Jefferies London Healthcare Conference. The company will engage in a fireside chat on November 20, 2024, from 11:00 to 11:25 AM GMT in London. The session will be moderated by Roger Song, MD, CFA, with participation from President and CEO John C. Jacobs and other management team members.

The company will also conduct investor meetings on the same day. A replay of the fireside chat will be accessible for 30 days on Novavax's investor relations website at ir.novavax.com.

Novavax (NVAX) reported Q3 2024 financial results with total revenue of $85 million, down from $187 million in Q3 2023. The company ended the quarter with $1 billion in cash and receivables. Key developments include FDA's removal of clinical hold on COVID-19-Influenza Combination vaccine candidates and authorization for updated 2024-2025 COVID-19 vaccine. The company updated its 2024 guidance, lowering total revenue expectations to $650-700 million from previous $700-800 million. Q3 net loss was $121 million, improving from $131 million loss in Q3 2023. Cost reduction efforts showed a 26% decrease in R&D and SG&A expenses compared to previous year.

Novavax announced that the FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the company to begin enrolling participants for the planned Phase 3 trial after determining that Novavax satisfactorily addressed all clinical hold issues. The hold, announced on October 16, 2024, was due to a serious adverse event reported in a participant who received the investigational CIC vaccine in a Phase 2 trial completed in 2023. The adverse event, initially reported as motor neuropathy, was later reclassified as amyotrophic lateral sclerosis, which is not associated with vaccination. Novavax plans to start the Phase 3 trial as soon as possible.

Novavax (NVAX) has scheduled its third quarter 2024 financial results and operational highlights conference call for November 12, 2024, at 8:30 a.m. ET. The company will host both a conference call and webcast, with replay options available until November 19, 2024, for the call and December 12, 2024, for the webcast. Participants can join through automated callback registration or direct operator assistance, and are advised to connect 10 minutes before the scheduled start.

Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. FDA has placed a clinical hold on its Investigational New Drug (IND) application for COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The hold is 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 participant reported the SAE in September 2024, after the trial completed in July 2023. Novavax is working with the FDA to provide necessary information and resolve the clinical hold. The company's Chief Medical Officer, Robert Walker, MD, emphasized that safety is their top priority and that causality has not been established for this event. Previous COVID-19 and influenza trials by Novavax have shown no signals for motor neuropathy. The COVID-19 IND for Novavax's COVID-19 vaccine is not affected by this clinical hold.

Novavax announced that the European Commission has granted Marketing Authorization for its updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine for individuals aged 12 and older in the European Union. The authorization follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use. Non-clinical data showed the updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses.

The vaccine is also authorized for use in the U.S. under an Emergency Use Authorization. Common adverse reactions include headache, nausea, muscle pain, joint pain, injection site tenderness, fatigue, and malaise. The vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years and older.