$103 Million Sale Funds Tropical Disease Products and Vaccines

Valneva SE announced today that it recently sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million.

The Company was awarded a tropical disease PRV in November 2023 following U.S. FDA approval of IXCHIQ®, Valneva's single-dose, live-attenuated vaccine indicated for preventing disease caused by chikungunya virus.

Under the Tropical Disease Priority Review Voucher Program, the FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria. The program is intended to encourage the development of new drugs and biologics to prevent and treat tropical diseases.

PRVs can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.

In a press release, Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "This non-dilutive capital provides an important source of additional funding to advance the continued development of our clinical pipeline."

"As shown with the recent approval of our chikungunya vaccine, we remain committed to growing our portfolio of vaccines addressing unmet medical needs which have the potential to transform people's lives."

With the FDA's approval in 2023, IXCHIQ became the world's first licensed chikungunya vaccine to address this unmet medical need.