Valneva's Chikungunya Vaccine Candidate Gets FDA Breakthrough Tag

The FDA grants Breakthrough Therapy Designation to Valneva SE's VALN single-shot chikungunya vaccine candidate, VLA1553.
This new U.S. milestone comes in addition to the FDA Fast Track designation and the European Medicines Agency's PRIME designation, which the Company received in December 2018 and in October 2020, respectively.
Valneva completed recruitment for the Phase 3 trial in April 2021 and expects to report topline data this summer.
The trial's primary objective is to evaluate the immunogenicity and safety of VLA1553 at 28 days following a single immunization.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, a Togaviridae virus transmitted by Aedes mosquitoes.
Price Action: VALN shares are up 1.1% at $28.00 during the market session on the last check Wednesday.