Invivyd Plunges 18.66% Amid FDA Setbacks

On May 15, 2025, Invivyd's stock experienced a significant drop of 18.66% in pre-market trading, reflecting a tumultuous start to the day for the biotechnology company.

Invivyd has recently filed a citizen petition with the FDA, urging the agency to prioritize the use of monoclonal antibodies for COVID-19 prevention in the endemic-virus era. This move comes as the company seeks to re-assess the current COVID-19 vaccine guidelines, aiming to modernize the regulatory framework.

In February 2025, the FDA declined Invivyd's request to expand the existing Emergency Use Authorization (EUA) for PEMGARDA, a decision that has had a notable impact on the company's stock performance. This regulatory setback has contributed to the recent volatility in Invivyd's share price, as investors grapple with the implications for the company's product pipeline.

Despite these challenges, Invivyd continues to focus on its discovery stage candidates for the prevention of seasonal influenza and COVID-19. The company's collaboration with Adimab, LLC, underscores its commitment to advancing innovative treatments in the biotechnology sector.