Invivyd announced that it has received a 12-month advance notice regarding the termination of the Emergency Use Authorization (EUA) for its drug Pemgarda®, and provided an update on its next steps in communication with the U.S. Food and Drug Administration (FDA).

This notice means that the emergency use authorization for Pemgarda will be officially terminated after the notice period expires. The company stated that it is actively evaluating the situation and has begun discussions with the FDA to clarify the follow-up regulatory path and possible options. Invivyd emphasized that it will continue to advance its research and development pipeline and maintain close cooperation with regulatory agencies to respond to current changes in the regulatory environment. The company plans to provide further updates to investors and the market once more definitive information is obtained.