Articles from Bavarian Nordic A/S

COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak.

COPENHAGEN, Denmark, February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Food and Drug Administration (FDA) has approved VIMKUNYA™ (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older.

COPENHAGEN, Denmark, January 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for VIMKUNYA® (CHIKV VLP vaccine) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older.

COPENHAGEN, Denmark, August 16, 2024 – Bavarian Nordic A/S (OMX: BAVA) has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX® (MVA-BN®) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.

COPENHAGEN, Denmark, August 13, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.

COPENHAGEN, Denmark, August 8, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that it has received a new order valued at USD 156.8 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to manufacture additional bulk product for JYNNEOS®, the company’s smallpox/mpox vaccine.

COPENHAGEN, Denmark, June 26, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The application was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) in February 2024, supporting the potential approval of the vaccine by the European Commission in the first half of 2025.

COPENHAGEN, Denmark, June 17, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the completion of the rolling submission process which was initiated in April 2024 with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older. Pending acceptance from the FDA, the BLA could support a potential approval of the vaccine in the first half of 2025.

COPENHAGEN, Denmark, May 31, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS® for prevention of smallpox and mpox disease in adults 18 years of age and older.

COPENHAGEN, Denmark, April 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older.

COPENHAGEN, Denmark, April 2, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today that JYNNEOS®, the only FDA-approved mpox vaccine, is now commercially available in the U.S., marking a significant expansion for access to JYNNEOS® by establishing additional pathways for vaccine procurement, distribution, and reimbursement by both public and private payers.

COPENHAGEN, Denmark, February 23, 2024 – Bavarian Nordic A/S (OMX: BAVA) (“the Company”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP, the Company’s investigational chikungunya vaccine.

COPENHAGEN, Denmark, August 6, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT05072080) of its virus-like particle (VLP)-based chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317) in adults and adolescents aged 12 to 64 years of age.

COPENHAGEN, Denmark, August 3, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, has placed a new order valued at USD 120 million, primarily covering the manufacturing of new bulk product for the Company’s smallpox/mpox vaccine.

COPENHAGEN, Denmark, June 27, 2023 – Bavarian Nordic A/S (OMX: BAVA) today reported topline results from a Phase 3 non-inferiority clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.

COPENHAGEN, Denmark, June 20, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today the initial safety and immunogenicity results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a virus-like particle (VLP)-based chikungunya virus (CHIKV) vaccine candidate CHIKV VLP (PXVX0317) in healthy adults ≥65 years of age. Results from a second Phase 3 study evaluating the safety and immunogenicity of CHIKV VLP in healthy adolescents and adults 12 to 64 years old will report data during the third quarter of 2023.

COPENHAGEN, Denmark, February 15, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today that it has entered into an agreement with Emergent BioSolutions Inc. (NYSE: EBS) (“Emergent”) to acquire two marketed travel vaccines, Vivotif® for the prevention of typhoid fever and Vaxchora® against cholera as well as a Phase 3 vaccine candidate for the prevention of Chikungunya virus for a total consideration of up to USD 380 million, including USD 270 million in an upfront payment and up to USD 110 million in future conditional milestone payments. The acquisition also includes facilities and key personnel related to the acquired assets.

COPENHAGEN, Denmark, December 23, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today a new agreement with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), for the advanced development of MVA-BN® WEV, a prophylactic vaccine candidate against Western, Eastern and Venezuelan equine encephalitis virus, which can cause a rare, but potentially deadly mosquito-borne illness in humans1. Currently, no approved vaccines for human use are available.

COPENHAGEN, Denmark, December 22, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Company has completed the planned enrollment of subjects in the global, randomized, double-blind Phase 3 clinical trial of its investigational respiratory syncytial virus (RSV) vaccine candidate, MVA-BN® RSV in adults ≥60 years of age.

COPENHAGEN, Denmark, October 17, 2022 – Bavarian Nordic A/S (OMX: BAVA) announced today the results of a six-month follow-up analysis from a Phase 2 clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.