ICVX Icosavax Inc

By Chris Wack

Icosavax Inc. said Tuesday the U.S. Food and Drug Administration granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus and human metapneumovirus virus-like particle vaccine candidate for older adults 60 years of age and above.

In October 2022, Icosavax said it had begun a Phase 1 study of IVX-A12 in up to 120 healthy adults aged 60 to 75 years. Icosavax expects to announce topline interim results from this Phase 1 trial in mid-2023, with subjects thereafter followed through 12 months after vaccination. The company plans to start a Phase 2 trial for IVX-A12 in the second half of 2023.

The FDA's Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need.

An investigational drug that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

Icosavax shares were up 9% to $9.85 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

February 21, 2023 08:40 ET (13:40 GMT)

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