STOCKHOLM, Dec. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that it has entered into a global exclusive license agreement with Bristol Myers Squibb (NYSE: BMY) for BioArctic's PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program, including BAN1503 and BAN2803, whereof the latter includes BioArctic's BrainTransporter™ technology. As part of the agreement, BioArctic will receive a USD 100 million upfront payment and up to USD 1.25 billion in milestone payments. BioArctic is also entitled to tiered low double-digit royalties on global product sales.

STOCKHOLM, Dec. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that it has entered into a global exclusive license agreement with Bristol Myers Squibb (NYSE: BMY) for BioArctic's PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program, including BAN1503 and BAN2803, whereof the latter includes BioArctic's BrainTransporter™ technology. As part of the agreement, BioArctic will receive a USD 100 million upfront payment and up to USD 1.25 billion in milestone payments. BioArctic is also entitled to tiered low double-digit royalties on global product sales.

STOCKHOLM  , Dec. 5, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first patient has been dosed with exidavnemab in the EXIST Phase 2a study, in Parkinson's disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, believed to play a role in the disease progression in different neurological disorders including Parkinson's disease.

The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blind, placebo-controlled study in Parkinson's disease patients to evaluate the safety and tolerability of exidavnemab. The study is conducted in Europe and at least 24 patients will be recruited in, divided into two cohorts of 12 (Cohort 1 and Cohort 2). Participants in Cohort 1 will receive either a lower dose of exidavnemab or placebo and participants in Cohort 2 will receive either a higher dose of exidavnemab or placebo. In addition to the primary endpoints, a broad range of biomarkers will be evaluated, in plasma, cerebrospinal fluid (CSF) and using digital measurements.

STOCKHOLM  , Dec. 5, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first patient has been dosed with exidavnemab in the EXIST Phase 2a study, in Parkinson's disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, believed to play a role in the disease progression in different neurological disorders including Parkinson's disease.

The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blind, placebo-controlled study in Parkinson's disease patients to evaluate the safety and tolerability of exidavnemab. The study is conducted in Europe and at least 24 patients will be recruited in, divided into two cohorts of 12 (Cohort 1 and Cohort 2). Participants in Cohort 1 will receive either a lower dose of exidavnemab or placebo and participants in Cohort 2 will receive either a higher dose of exidavnemab or placebo. In addition to the primary endpoints, a broad range of biomarkers will be evaluated, in plasma, cerebrospinal fluid (CSF) and using digital measurements.

STOCKHOLM, Dec. 5, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1.  

Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils2), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in Alzheimer's disease, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqembi is also approved and being marketed in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain.

STOCKHOLM, Dec. 4, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1.  

Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils2), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in Alzheimer's disease, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism. Leqembi is also approved and being marketed in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain.

STOCKHOLM, Nov. 28, 2024 /PRNewswire/ - BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai today announced today that Leqembi® (generic name: lecanemab) has been launched in South Korea. Leqembi received approval in South Korea in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD).

Eisai estimates there were approximately 900,000 dementia patients in South Korea in 2021, with one in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). It is reported that Alzheimer's dementia patients account for about 70 percent of all dementia patients.[1] In South Korea, Eisai will first launch Leqembi in the private market.

STOCKHOLM, Nov. 27, 2024 /PRNewswire/ - BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai today announced today that Leqembi® (generic name: lecanemab) has been launched in South Korea. Leqembi received approval in South Korea in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD).

Eisai estimates there were approximately 900,000 dementia patients in South Korea in 2021, with one in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). It is reported that Alzheimer's dementia patients account for about 70 percent of all dementia patients.[1] In South Korea, Eisai will first launch Leqembi in the private market.

STOCKHOLM, Nov. 14, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai's marketing authorization application (MAA) for lecanemab as treatment of Alzheimer's disease. The recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. 

STOCKHOLM, Nov. 14, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai's marketing authorization application (MAA) for lecanemab as treatment of Alzheimer's disease. The recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.