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Valneva SE VALN, a specialty vaccine company, recently reported positive Phase 3 - VLA1553-321 data in adolescents (12 to 17 years old) for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ. For investors’ note, IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need.
The trial data supports and strengthens the pivotal data previously reported for adolescents in the United States, Europe and Canada. Data from this trial are also expected to support the licensure of IXCHIQ in Brazil.
The new favorable data from the Phase 3 trial helped Valneva advance the furthest along the clinical development timeline.
Impact of the News on VALN Stock
Subsequent to the news, the share price of VALN jumped 1.4% to $4.37 yesterday.
The latest development is capable of generating positive market sentiment, considering the rising number of chikungunya cases in select geographies. We therefore expect market sentiment toward VALN stock to be positive surrounding this news.
Valneva boasts a market capitalization of $346.6 million. The company is estimated to report 8.3% earnings growth in 2024.
About VALN’s Favorable Phase 3 Trial Data
The one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% one year after vaccination. The results complement the long-term persistence data previously reported for adults, confirming a strong and long-lasting antibody response to the vaccine.
Additionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents. Throughout the trial, an Independent Data Safety Monitoring Board consistently assessed safety data and found no safety issues.
About Phase 3 Study VLA1553-321
VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents in Brazil.
The trial was conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 program, the VLA1553-321 trial, which represents the first clinical trial conducted in an endemic area and upon individuals previously infected with CHIKV.
Recent Global Expansion of VALN
The FDA application complements the recent label extension submissions to the European Medicines Agency and Health Canada, highlighting Valneva’s strategic push to enhance IXCHIQ’s global reach.