Read Why Valneva's Stock Gained 7% Today

Valneva SE VALN completed the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553.
Valneva posted topline results from the phase 3 trial in August last year. The primary endpoint result is mainly unchanged from that data drop.
The removal of two subjects from the analysis increased the proportion of participants with protective neutralizing antibody titers from 98.5% to 98.9%, 28 days after receiving a single shot of VLA1553.
Valneva now also has longer-term immunogenicity data. After six months, 96.3% of the analyzed subjects had protective levels of CHIKV neutralizing antibodies.
The slight decline between the first and sixth months of the trial still leaves Valneva well above the 70% level of seroprotection it expects the FDA to use as a surrogate of protection.
Valneva plans to monitor the durability of the antibody response in a subset of participants for at least five years as part of a dedicated persistence trial.
With topline lot-to-lot manufacturing consistency results for VLA1553 due in Q2, Valneva is now close to gathering the evidence it will need to file for approval in the U.S.
The plan is to start the pre-submission process with the FDA in the second quarter.
Suppose Valneva hits that target and avoids any regulatory setbacks. In that case, it should receive a priority review voucher for becoming the first company to win approval for a chikungunya vaccine in the U.S.
Price Action: VALN shares closed 7.40% at $29 on Tuesday.