06:04 PM EDT, 08/14/2025 (MT Newswires) -- Invivyd ( IVVD ) said late Thursday it received advice from the US Food and Drug Administration on a rapid pathway to potential biologics license application approval for VYD2311 for protection against COVID-19.

The alignment follows a Type C meeting, where the FDA advised that a single, phase 2/3 trial evaluating the candidate efficacy from RT-PCR-confirmed symptomatic COVID-19 cases could support a BLA submission for a broad US population of adults and adolescents aged 12 years and older weighing at least 40 kg, subject to a pending full protocol review.

The FDA advice was based on observations of the company's execution of its phase 3 trial of pemivibart for the prevention of COVID-19 and the antiviral durability of the drug, the company said.

Invivyd ( IVVD ) now plans to study two doses of VYD2311 to analyze any differences in levels of protection or safety, with a goal to expand choices for US populations requiring COVID-19 protection, according to the company.

It added that quantities of VYD2311 are available for potential commercial launch.