Novavax seeks FDA nod for updated COVID-19 vaccine By Investing.com

GAITHERSBURG, Md. – Novavax , Inc. (NASDAQ: NASDAQ:) has announced its submission for an amended Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 and older. This move comes in response to guidance from the FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO), which recommend targeting the JN.1 lineage for the upcoming vaccination season.

The company’s latest vaccine candidate has shown the ability to generate broad cross-neutralizing antibodies against multiple strains, including the KP.2 and KP.3 variants. Novavax’s president and CEO, John C. Jacobs, emphasized the importance of offering a protein-based vaccine option to potentially enhance vaccination rates.

Novavax’s JN.1 vaccine is designed using the company’s recombinant nanoparticle technology to create copies of the SARS-CoV-2 spike protein, combined with its patented Matrix-M adjuvant to boost the immune response. The vaccine is ready to use in liquid form and can be stored at standard refrigeration temperatures, which simplifies distribution.

The company plans to have doses available in the United States by mid-August, pending FDA authorization and CDC recommendation. Novavax is also in discussions with other global regulatory agencies for the approval of its JN.1 COVID-19 vaccine.

The press release statement from Novavax also highlighted the nonclinical data demonstrating that the vaccine elicits a broad neutralization response to JN.1 lineage viruses and a range of variants. Additionally, the vaccine prompts a Th1-biased CD4+ T cell response, which is crucial for long-term immunity.

The company’s efforts are part of a broader strategy to address the evolving challenge of COVID-19 and its variants, aiming to provide an alternative to mRNA vaccines currently available. Novavax’s approach to vaccine development focuses on protein-based formulations, which could offer different immunogenic profiles compared to other vaccine types.

As the COVID-19 pandemic continues to pose a global health threat, Novavax’s submission represents a proactive measure to anticipate and combat circulating and future strains of the virus. The company’s readiness to distribute the vaccine, upon regulatory green light, underscores its commitment to contribute to the worldwide vaccination effort.

In other recent news, Novavax is awaiting approval from the U.S. Food and Drug Administration (FDA) to release its COVID-19 vaccine, designed to target the JN.1 variant. The company has faced challenges in bringing its protein-based COVID-19 vaccine to market. However, a recent licensing agreement with Sanofi (NASDAQ:), valued at a minimum of $1.2 billion, has provided a significant boost. Despite this, Novavax forecasts revenues ranging from $400 million to $600 million for 2024, a notable decrease from 2023’s $983.7 million.

In a related development, Pfizer (NYSE:), BioNTech (NASDAQ:), Moderna (NASDAQ:), and Novavax have announced that their latest COVID-19 vaccines show promising results against newer subvariants. Pfizer and BioNTech, along with Moderna, are ready to supply the updated vaccines immediately upon approval. Novavax anticipates being able to provide their vaccine by autumn, pending regulatory approval.

Meanwhile, Shah Capital, a hedge fund owning approximately 7.8% of Novavax, has withdrawn its campaign against the re-election of three Novavax board directors. The decision follows Novavax’s recent licensing agreement with Sanofi. Despite withdrawing its campaign, Shah Capital maintains that Novavax would benefit from having a stockholder representative on the board.

On another note, companies across North America, including Novavax, are initiating significant workforce reductions. This trend, affecting a variety of sectors, continues despite a cautiously optimistic economic outlook and uncertain future rate cuts by the Federal Reserve.

InvestingPro Insights

As Novavax, Inc. (NASDAQ: NVAX) gears up to enhance global vaccination efforts with its latest COVID-19 vaccine candidate, NVX-CoV2705, the company’s financial and market performance provides a backdrop to its scientific endeavors. According to InvestingPro, Novavax has been navigating a challenging financial landscape, with a significant cash burn rate that investors should monitor closely. This situation is reflected in the company’s substantial operating loss over the last twelve months, amounting to $378.17 million USD. Additionally, Novavax’s gross profit margin stands at a modest 4.92%, underscoring the financial pressures it faces amidst its vaccine development and distribution efforts.

Despite these financial hurdles, Novavax’s stock has experienced a strong return over the last three months, with a price total return of 202.21%. This surge may reflect investor optimism regarding the company’s potential profitability this year, as predicted by analysts. However, the stock’s high price volatility, as indicated by a one-week price total return of -17.17%, suggests that investors should be prepared for potential swings in the market.

For those seeking a deeper analysis of Novavax’s financial health and stock performance, InvestingPro offers a range of additional insights. There are currently 12 more InvestingPro Tips available, which can be found at InvestingPro. Readers interested in leveraging these insights can take advantage of a special offer by using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

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