VALN Regulatory

Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information

Published August 07, 2025 at 05:18 AM

Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ®. IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.

Related Questions

How might this regulatory development impact Valneva's share price in the short term (1‑2 weeks) and medium term (1‑3 months)? Are there any pending FDA or EMA submissions that could further influence Valneva's pipeline valuation? What is the potential effect on Valneva's partnership agreements or licensing deals related to IXCHIQ®? How will the removal of the FDA‑recommended pause for the 60+ age group affect Valneva's sales forecasts and revenue guidance? Will the updated prescribing information lead to broader market adoption or new indications for IXCHIQ® in the United States? What is the expected change in demand for IXCHIQ® among high‑risk populations now that the elderly can be vaccinated? How does this news compare to recent regulatory updates for competing chikungunya or arbovirus vaccine developers? How might this development influence analyst sentiment and target price revisions for VALN stock? What are the broader implications for Valneva's overall vaccine franchise and its positioning in the emerging infectious disease market? Will the removal of the pause trigger any changes in the company's manufacturing capacity or supply chain requirements?