FDA declines Invivyd’s COVID-19 treatment EUA expansion

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a biotechnology company with a market capitalization of $192.58 million, faced a setback today as the U.S. Food and Drug Administration (FDA) declined to expand the Emergency Use Authorization (EUA) for its monoclonal antibody PEMGARDA™ (pemivibart) to include treatment for certain immunocompromised patients with mild-to-moderate COVID-19. Despite this news, the stock has shown remarkable resilience, posting a 299.46% return year-to-date. The existing EUA for pre-exposure prophylaxis in similar patients remains unaffected.

The FDA’s decision was influenced by their requirement for immunobridging analyses to demonstrate superior, rather than equivalent, antiviral activity compared to previously authorized COVID-19 monoclonal antibodies. Invivyd’s submission showed that pemivibart had comparable antiviral activity to adintrevimab, a key comparator antibody, and was predicted to be clinically effective based on past authorized therapies. According to InvestingPro data, the company maintains impressive gross profit margins of 92.27%, though analysts don’t expect profitability this year. For deeper insights into Invivyd’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.

Invivyd’s Senior Vice President of Clinical Development, Mark Wingertzahn, expressed disappointment, citing the urgent need for additional COVID-19 treatments, especially for the immunocompromised who have limited options. Dr. Alfred H. Kim, MD, PhD, from Washington University School of Medicine, echoed these sentiments, emphasizing the inadequacy of current treatments for this vulnerable group.

Despite the FDA’s decision, Invivyd plans to continue working with the agency to advance PEMGARDA as a COVID-19 treatment and will rapidly progress the development of another monoclonal antibody candidate, VYD2311. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates it’s quickly burning through cash reserves. The company intends to release detailed data and regulatory correspondence concerning pemivibart, VYD2311, and the immunobridging of COVID-19 antibodies to highlight the handling of these assets compared to COVID-19 vaccines and small molecule treatments. InvestingPro subscribers have access to 10+ additional key insights about Invivyd’s financial health and market performance.

PEMGARDA, engineered from adintrevimab, has shown in vitro neutralizing activity against major SARS-CoV-2 variants and is currently authorized for pre-exposure prophylaxis in certain immunocompromised patients. However, the EUA does not cover post-exposure prophylaxis or treatment of COVID-19.

Invivyd is also developing VYD2311, a novel monoclonal antibody candidate for COVID-19, which may offer patient-friendly administration routes and is based on the same antibody backbone as pemivibart.

The company’s efforts are part of its broader mission to provide protection against serious viral infectious diseases, starting with SARS-CoV-2. This news update is based on a press release statement from Invivyd.

In other recent news, Invivyd Inc. pre-announced its fourth-quarter financials, reporting net product revenues of $13.8 million, which fell short of the estimated $15.4 million. However, the company’s cash position at the end of 2024 was $69.3 million, surpassing expectations. H.C. Wainwright maintained its Buy rating for Invivyd, setting a price target of $10, citing positive developments, including a 48% sequential revenue increase for its monoclonal antibody, PEMGARDA. Meanwhile, Invivyd submitted an updated immunobridging analysis to the FDA to amend the Emergency Use Authorization for pemivibart, aimed at treating COVID-19 in immunocompromised patients. The analysis highlighted the drug’s strong serum virus neutralizing antibody titers against the dominant SARS-CoV-2 variant XEC. Additionally, Invivyd received a Nasdaq delisting warning due to its stock price falling below the required $1.00 bid price for 30 consecutive days. The company is exploring options to address this issue within a 180-day compliance period. Lastly, Sara Cotter resigned from Invivyd’s Board of Directors, with no public explanation provided for her departure.

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