On October 29, 2024, Invivyd, Inc., a biopharmaceutical company, released preliminary financial results for the third quarter of 2024 and withdrew its previous financial guidance. The company reported preliminary net product revenue of $9.3 million from PEMGARDA™ (pemivibart) and ended the quarter with approximately $107 million in cash and cash equivalents. Invivyd revised its year-end cash balance projection to $65 million or more, down from the previously guided $75 million or more. The revision follows the U.S. FDA's late-Q3 2024 warning about the potential reduced activity of pemivibart, which led to confusion among healthcare providers and the immunocompromised community. Despite these challenges, Invivyd is targeting near-term profitability by the first half of 2025 through anticipated revenue growth and operational efficiencies. The company also announced positive...Show More

On October 29, 2024, Invivyd, Inc., a biopharmaceutical company, released preliminary financial results for the third quarter of 2024 and withdrew its previous financial guidance. The company reported preliminary net product revenue of $9.3 million from PEMGARDA™ (pemivibart) and ended the quarter with approximately $107 million in cash and cash equivalents. Invivyd revised its year-end cash balance projection to $65 million or more, down from the previously guided $75 million or more. The revision follows the U.S. FDA's late-Q3 2024 warning about the potential reduced activity of pemivibart, which led to confusion among healthcare providers and the immunocompromised community. Despite these challenges, Invivyd is targeting near-term profitability by the first half of 2025 through anticipated revenue growth and operational efficiencies. The company also announced positive Phase 3 clinical trial data for PEMGARDA, showing substantial protection from symptomatic COVID-19 in immunocompetent participants over six months without additional doses. Invivyd's management prepared the preliminary financial data, which has not been audited or reviewed by PricewaterhouseCoopers LLP, the company's independent registered public accounting firm. The company plans to provide a further update on its Q3 2024 earnings call.