Invivyd Inc. Engages FDA for Expedited Pathway on COVID-19 Monoclonal Antibody Development Amidst Regulatory Review

Reuters

05/21

Invivyd Inc. Engages FDA for Expedited Pathway on COVID-19 Monoclonal Antibody Development Amidst Regulatory Review

Invivyd Inc. has announced plans to engage with the U.S. Food and Drug Administration (FDA) on an expedited pathway to develop next-generation COVID-19 prevention and treatment options. This initiative comes as the FDA acknowledges uncertainties in the efficacy of current COVID-19 vaccine boosters and aligns with Invivyd's Citizen Petition requests. The company aims to advance its monoclonal antibody therapies, including the investigational mAb VYD2311, to provide scalable and high-quality protection against modern immune-evasive SARS-CoV-2 viruses. Invivyd anticipates a clinical update on VYD2311 this quarter, marking a significant step in addressing the ongoing challenges posed by COVID-19, especially for high-risk populations.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Invivyd Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9455783-en) on May 21, 2025, and is solely responsible for the information contained therein.

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