Saint Herblain (France), February 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world’s first and only chikungunya vaccine, IXCHIQ®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is ...

Saint Herblain (France), February 5, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for the world's first and only chikungunya vaccine, IXCHIQ®. The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older. The vaccine is manufactur ...

Saint Herblain (France), January 30, 2025 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced the signing of a new $32.8 million contract with the United States (U.S.) Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, IXIARO®.Under this new one-year contract, the DoD will buy a minimum of $32.8 million worth of IXIARO® vaccines and has the possibility to purchase additional doses during the coming twelve months. Deliveries of IXIARO® doses ...

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 e ...

Antibody levels remained high at 96% seroresponse in line with the two-year persistence data This long-lasting antibody persistence was comparable in older (65+) and younger adults Saint-Herblain (France), December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s expectations for this vaccine, confi ...

Valneva SE (VALN) recently applied for a label extension to the FDA to potentially extend the use of its chikungunya vaccine, IXCHIQ. Currently approved for adults, the vaccine may soon be accessible to adolescents aged 12 to 17 years, following the label extension. This submission is backed by positive adolescent Phase 3 data that demonstrated a 99.1% immune response rate and a favorable safety profile in adolescents. Expanding access to this age group addresses a critical gap, particularly as chikungunya ...

To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ®, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody ...

Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate ...

Valneva SE (NASDAQ:VALN) Q3 2024 Earnings Conference Call November 7, 2024 9:00 AM ET Company Participants Thomas Lingelbach - Chief Executive Officer Peter Buhler - Chief Financial Officer Joshua Drumm - Vice President of Investor Relations Conference Call Participants Maury Raycroft - Jefferies Chiara Montironi - Van Lanschot Kempen Ed White - HC Wainwright Rajan Sharma - Goldman Sachs Samir Devani - Rx Securities Joshua Drumm Thank you for joining us to discuss Valneva’s Financial Results for the First ...

 Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 millionNet Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R& ...