Question · Q3 2025
Alexa Diemer from Cantor Fitzgerald inquired about Invivyd's plans for PEMGARDA once the next-generation product, VYD2311, receives approval, specifically asking if the company intends to wind down PEMGARDA and over what timeframe. She also asked for clarification on the required coordination between CBER and CDER for the LIBERTY study.
Answer
Marc Elia, Chairman of Invivyd's Board of Directors, stated that Invivyd has no plans to actively sunset PEMGARDA, acknowledging its differentiated molecular properties despite potential scalability challenges. Regarding the LIBERTY study, Mr. Elia explained that the coordination between CBER and CDER is a logistical step due to differing legal responsibilities for therapeutic monoclonal antibodies (CDER) and prophylactic medicines (CBER), especially when combining them in a single study. He noted that this is an unusual but interesting study, and the company anticipates alignment on the study's nature and boundaries.