FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients

Core Viewpoint - The FDA has declined Invivyd, Inc.'s request to expand the emergency use authorization for its COVID-19 treatment Pemgarda, which remains authorized only for certain immunocompromised patients [1][3]. Group 1: FDA Decision - The FDA's reasoning for declining the request is based on the belief that immunobridging analyses for monoclonal antibodies must demonstrate superior antiviral activity compared to previously authorized COVID-19 mAbs [3]. - The existing emergency use authorization for Pemgarda for pre-exposure prophylaxis in specific immunocompromised patients is still in effect [1]. Group 2: Financial Implications - The company indicated that the COVID-19 treatment opportunity for pemivibart was not included in its existing financial guidance [2]. Group 3: Clinical Data and Market Reaction - Invivyd released new data from the ongoing Phase 1/2 trial of VYD2311, showing high serum concentrations that may increase the observed half-life compared to pemivibart [4]. - Following the FDA's decision, Invivyd's stock price fell by 29.9%, trading at $1.24 during the premarket session [4].