Valneva to withdraw Chikungunya vaccine from US amid safety woes [Yahoo! Finance]
Valneva SE - American Depositary Shares (VALN)
Company Research
Source: Yahoo! Finance
French vaccine developer Valneva said it is voluntarily pulling the paperwork underlying the approval of its chikungunya virus shot in the U.S., ending a short-lived marketing run marred by safety concerns. In a Monday statement, Valneva said it recently learned that the Food and Drug Administraiton placed a clinical hold on the vaccine, Ixchiq, pending an investigation of a newly reported serious adverse event that occurred outside the U.S. The company has responded by withdrawing its FDA applications altogether. Ixchiq was awarded an accelerated approval in November 2023. That clearance made Ixchiq the first shot in the U.S. cleared to prevent illness caused by the chikungunya virus, a pathogen typically spread through infected mosquitoes. Infections can cause fever and severe joint pain that, in some cases, may be persistent and debilitating. Ixchiq, however, has come under heavy scrutiny over the last year amid mounting concerns about its safety. The European Medicines Agen
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News
- Valneva Provides Update on Chikungunya Vaccine IXCHIQ®GlobeNewswire
- Valneva to Meet with Investors during the J.P. Morgan Healthcare ConferenceGlobeNewswire
- Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License Agreement [Yahoo! Finance]Yahoo! Finance
- Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License AgreementGlobeNewswire
- Valneva Reports Positive Final Phase 2 Antibody Persistence and Safety Results in Children for its Chikungunya Vaccine IXCHIQ®GlobeNewswire
VALN
Sec Filings
- 1/20/26 - Form 6-K
- 1/9/26 - Form 6-K
- 12/31/25 - Form 6-K
- VALN's page on the SEC website