Valneva Sells Priority Review Voucher for $103M

Specialty vaccine company Valneva SE (Nasdaq: VALN), has sold an FDA Priority Review Voucher (PRV) for $103 million. The company will invest proceeds from the sale of the PRV into the development of its Phase 3 vaccine candidate against Lyme disease, additional clinical trials for its chikungunya vaccine IXCHIQ® and the expansion of its clinical pipeline.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, “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.”

Highlights

Valneva was awarded a tropical disease PRV in November 2023 after receiving FDA approval of IXCHIQ®, its single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV).

IXCHIQ® is the world’s first licensed chikungunya vaccine.

Chikungunya is a mosquito-borne viral disease. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite, and while mortality with CHIKV is low, morbidity is high.

Valneva says the global market for vaccines against chikungunya is estimated to exceed $500 million.

About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

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Valneva Sells Priority Review Voucher for $103M

Catie Corcoran

Biotech Editor