Valneva Sells FDA Priority Review Voucher For $103 Mln After Chikungunya Vaccine Approval

(RTTNews) - Valneva SE (VALN) said Monday that it sold the Priority Review Voucher it received from the U.S. Food and Drug Administration for $103 million or 95 million euros.

The company was awarded a tropical disease Priority Review Voucher in November 20231 following U.S. FDA approval of IXCHIQ, the company's single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

Valneva stated that it will invest proceeds from the sale of the Priority Review Voucher into its R&D projects, including the co-development of its Phase 3 vaccine candidate against Lyme disease, additional clinical trials for its chikungunya vaccine IXCHIQ and the expansion of the Company's clinical pipeline.

Under the tropical Disease Priority Review Voucher Program, FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of tropical diseases. PRVs can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.