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Valneva Expands Use of Chikungunya Vaccine for Adolescents

Valneva SE has submitted applications for the label extension of its chikungunya vaccine IXCHIQ to include adolescents aged 12-17 in Europe and Canada. The company is also working towards a U.S. submission this year, which could positively impact future sales.

Date: 
AI Rating:   7

Valneva SE (VALN) is actively seeking to expand the use of its chikungunya vaccine, IXCHIQ, by submitting label extension applications to the European Medicines Agency (EMA) and Health Canada. This strategic move aims to include adolescents aged 12 to 17 years in the approval, which may diversify the vaccine’s market exposure. Importantly, the Canadian application brings in two-year antibody persistence data, emphasizing IXCHIQ's strong profile in comparison to competitors.

Furthermore, the company plans to submit supportive data to the U.S. Food and Drug Administration (FDA) within the year, indicating that they are keen on penetrating the U.S. market further after the vaccine’s initial approval for individuals aged 18 and older. The anticipated launch in Canada and Europe is set for the fourth quarter of 2024, suggesting that the company is on track to capitalize on the growing demand for chikungunya prevention among younger populations.

In addition, Valneva's expectations for obtaining marketing authorization in Brazil by the second half of 2024, alongside their partnership with The Coalition for Epidemic Preparedness Innovations (CEPI), positions them well to support broader access to their vaccine in Low and Middle-Income Countries (LMICs). The up to $41.3 million funding from CEPI and the European Union's Horizon Europe program illustrates substantial backing for Valneva’s initiatives, especially in post-marketing trials and potential extensions in pediatric and pregnant demographics.

In summary, while there is no specific mention of Earnings Per Share (EPS), Revenue Growth, Net Income, Profit Margins, Free Cash Flow, or Return on Equity discussed in the report, the strategic moves by Valneva SE to broaden its market through label extension applications and international partnerships suggest optimistic future prospects that could positively affect stock performance.

Stocks:  VALN