Invivyd, Inc. (Nasdaq: IVVD) has announced that a Type C meeting is scheduled with the FDA for early in the third quarter of 2025 to discuss the registration-directed next steps for its VYD2311 program, a next-generation monoclonal antibody candidate designed to prevent and treat COVID-19. This meeting will focus on the approval pathways for VYD2311 and other follow-on COVID-19 monoclonal antibodies, with particular attention to treatment options for active COVID-19 and prophylaxis for vulnerable populations, including the elderly, immunocompromised individuals, and pediatric populations. Invivyd plans to release additional information about the VYD2311 program throughout 2025.
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