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WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company with a market capitalization of $103 million and impressive gross profit margins of 94%, has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA), advocating for an updated approach to evaluating COVID-19 vaccines and monoclonal antibodies (mAbs). InvestingPro analysis shows the company maintains a strong balance sheet with more cash than debt, positioning it well for its development initiatives. The company suggests that the FDA’s current methods do not adequately reflect the evolving landscape of SARS-CoV-2 and the immunological changes in the American population.
The petition highlights that most Americans now have some immunity to COVID-19, either from vaccination or infection, unlike when initial vaccine efficacy studies were conducted. Invivyd points out that the virus has evolved significantly since the original Wuhan strain, with current Omicron lineages showing greater resistance to immune responses.
Invivyd’s proposal includes conducting new clinical trials that are randomized and placebo-controlled, involve seropositive participants, target contemporary Omicron variants, and extend over at least six months to better measure vaccine efficacy.
The company emphasizes the importance of these trials in maintaining a positive risk-benefit profile for COVID-19 vaccines based on up-to-date data. Additionally, the petition recommends that the FDA consider serum virus neutralizing antibody (sVNA) titers as a surrogate endpoint for Biologics License Application (BLA) approval, which could streamline patient access to alternative preventative treatments like mAbs. According to InvestingPro data, analysts expect the company to achieve profitability this year, with projected sales growth of 6.2%. Get access to 12 more exclusive InvestingPro Tips and comprehensive analysis through the Pro Research Report.
Invivyd, which received emergency use authorization (EUA) from the FDA for a monoclonal antibody in March 2024, is focused on creating advanced antibodies to protect against serious viral infectious diseases, including COVID-19.
The FDA’s response to Invivyd’s petition and the potential implications for vaccine and mAb development are yet to be determined. This news is based on a press release statement from Invivyd, Inc. The company’s stock has shown significant momentum, recording a 47% return over the past week, though InvestingPro analysis indicates the stock may be currently overbought. Discover more detailed insights and Fair Value estimates with an InvestingPro subscription.
In other recent news, Invivyd, Inc. has initiated a discovery program to develop a monoclonal antibody for treating measles, aiming to identify a preclinical candidate by 2025. The company also secured a $30 million loan facility from Silicon Valley Bank to support the development of its COVID-19 monoclonal antibody, VYD2311. Invivyd’s PEMGARDA, a monoclonal antibody for COVID-19, continues to show efficacy against prevalent SARS-CoV-2 variants, maintaining its authorization for pre-exposure prophylaxis in immunocompromised individuals. However, the FDA declined to expand the Emergency Use Authorization for PEMGARDA to include treatment for mild-to-moderate COVID-19, citing the need for superior antiviral activity compared to existing therapies. Despite this, Invivyd plans to work with the FDA to advance PEMGARDA as a treatment option and continue developing VYD2311. Additionally, venture capitalist Ajay Royan joined Invivyd’s Board of Directors, bringing expertise in healthcare investments. These developments reflect Invivyd’s ongoing efforts to address serious viral infectious diseases through its monoclonal antibody technology.
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