Valneva Withdraws Ixchiq BLA, Posts Wider FY2025 Loss, and Advances Lyme Vaccine
Valneva withdrew its U.S. BLA and IND for chikungunya vaccine Ixchiq after an FDA clinical hold tied to a serious adverse event. The company reported a wider FY2025 net loss of €115.2 million, while its Lyme vaccine VLA15 showed over 70% efficacy in Phase III.
Valneva SE announced that the Company has decided to voluntarily withdraw the biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, Ixchiq, in the United States, following suspension of the license by the U.S. Food and Drug Administration (FDA) in August 2025. Valneva was recently informed of the FDA’s further decision to place the IND on clinical hold pending an investigation of a newly reported foreign Serious Adverse Event (SAE).
The SAE occurred outside of the U.S. and involved a younger adult who received three concomitant vaccines, including Ixchiq. Based on the information made available to Valneva, the case may be plausibly related to Ixchiq vaccination, but causality has not been determined. There are currently no clinical studies involving Ixchiq that are actively vaccinating participants, and the Company intends to move forward with its planned post-marketing clinical activities, subject to further discussions with relevant regulatory authorities. Ixchiq remains licensed in Europe, Canada, the United Kingdom and Brazil.
Separately, Valneva’s Lyme disease vaccine candidate VLA15 achieved Phase III point efficacy above 70% with what management calls a very good safety profile. Pfizer has already filed with the EMA and is working toward a BLA with the FDA. The first Phase 3 data readout for VLA15 was anticipated in the first half of 2026, and regulatory submissions are expected to follow as planned by Pfizer, subject to positive results. If approved, VLA15 will be the fourth vaccine successfully developed by Valneva.
For the full year 2025, Valneva reported total revenues of €174.7 million, including €157.9 million in product sales, compared with €169.6 million in 2024. The net loss amounted to €115.2 million compared to a net loss of €12.2 million in 2024, while the prior year amount benefited from a €90.8 million net gain related to the sale of the Priority Review Voucher received for IXCHIQ. Operating cash burn improved to €52.9 million in 2025 compared to €67.2 million in 2024 and €202.7 million in 2023. Cash at year-end was €109.7 million, down from €168.3 million.
In the second quarter of 2026, Valneva recorded revenue of €34.94 million, down 27.7% from €48.33 million in the same period of 2025, and a net loss of €31.20 million, widening from a loss of €11.59 million. Product sales for the first half of 2026 fell to €64 million. The company booked €3.2 million of restructuring costs, and IXCHIQ was hit by inventory write-downs and cancellation fees, which turned its contribution negative.
In 2025, IXIARO/JESPECT sales increased by 4.6% to €98.4 million. Third-party product sales declined 42.3% to €19.2 million as the main third-party distribution contract concluded, while proprietary product sales increased by 9% at constant exchange rate. More than 50,000 people have received IXCHIQ in Brazil, with a target of at least 100,000 for active safety monitoring, and Instituto Butantan’s version has been approved for Brazil’s public system.
For 2026, Valneva confirmed financial guidance for total revenues between €155 million and €170 million, including product sales of €145-160 million. First Phase 2 data for the tetravalent Shigella vaccine candidate S4V2 are expected mid-2026, with a decision on subsequent development steps in the second half of 2026.