FDA accepts sBLA for traditional approval of LEQEMBI™ (lecanemab-irmb) for the treatment of Alzheimer’s disease and grants Priority Review March 6, 2023 00:30 Regulatory Read more
Number of shares and votes in BioArctic AB (publ) as of February 28, 2023 February 28, 2023 18:00 Regulatory Read more
The Nomination Committee’s proposal for the election of Board members and Chairman of the Board in BioArctic AB February 6, 2023 08:30 Regulatory Read more
European Medicines Agency accepts Marketing Authorization Application for lecanemab as treatment for early Alzheimer’s disease January 27, 2023 00:30 Regulatory Read more
BioArctic’s Chairman of the Board Wenche Rolfsen declines re-election January 19, 2023 09:50 Regulatory Read more
BioArctic’s partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer’s disease in Japan January 16, 2023 01:30 Regulatory Read more
BioArctic’s partner Eisai submits marketing authorization application for lecanemab as treatment for early Alzheimer’s disease in the EU January 11, 2023 00:30 Regulatory Read more
FDA approves LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval pathway for the treatment of Alzheimer’s disease January 6, 2023 20:30 Regulatory Read more
Number of shares and votes in BioArctic AB (publ) as of November 30, 2022 November 30, 2022 18:00 Regulatory Read more
BioArctic’s partner Eisai presents results of lecanemab Phase 3 confirmatory Clarity AD study for Early Alzheimer’s disease at CTAD conference November 30, 2022 01:50 Regulatory Read more
Full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease published in the New England Journal of Medicine November 30, 2022 01:50 Regulatory Read more
BioArctic’s founders intend to divest minor part of their shareholding October 25, 2022 17:35 Regulatory Read more
Lecanemab phase 3 Clarity AD study in early Alzheimer’s disease meets primary and all key secondary endpoints with high statistical significance September 28, 2022 01:30 Regulatory Read more
The FDA accepts BLA and grants priority review for lecanemab for treatment of early Alzheimer’s disease under the accelerated approval pathway July 6, 2022 01:30 Regulatory Read more
Eisai completes rolling submission to the FDA of lecanemab for early Alzheimer’s disease under the accelerated approval pathway May 10, 2022 01:35 Regulatory Read more
AbbVie terminates collaboration with BioArctic on alpha-synuclein portfolio April 20, 2022 07:50 Regulatory Read more
The Nomination Committee’s proposal for the election of board members in BioArctic AB March 9, 2022 08:00 Regulatory Read more
Eisai initiates submission of application data of lecanemab under the prior assessment consultation system in Japan with the aim of an earlier regulatory approval March 4, 2022 00:46 Regulatory Read more
Eisai initiates rolling submission for the US FDA Biologics license application of lecanemab for early Alzheimer’s disease under the accelerated approval pathway September 28, 2021 01:37 Regulatory Read more
FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer’s disease June 23, 2021 22:11 Regulatory Read more
The Nomination Committee’s proposal for the election of board members in BioArctic AB February 12, 2021 08:00 Regulatory Read more
Invitation to presentation of BioArctic’s Interim Report for the period January – June 2020 on July 10 at 9.30 a.m. CET July 1, 2020 08:30 Regulatory Read more
Members of BioArctic’s Board of Directors and management increase their shareholdings May 26, 2020 15:30 Regulatory Read more
Invitation to presentation of BioArctic’s Interim Report for the first quarter 2020 on April 22 at 9.30 a.m. CET April 15, 2020 08:30 Regulatory Read more
The Nomination Committee’s proposal for the election of board members in BioArctic AB March 24, 2020 08:00 Regulatory Read more
BioArctic announces research collaboration with Eisai regarding BAN2401 December 17, 2019 15:59 Regulatory Read more
BioArctic’s partner Eisai presents data from the ongoing BAN2401 Phase 2b extension study in early Alzheimer’s disease December 5, 2019 20:15 Regulatory Read more
BioArctic announces results from interim analysis of the Phase 1/2 study of SC0806 in patients with complete spinal cord injury November 18, 2019 22:30 Regulatory Read more
BioArctic presents Nomination Committee and publishes financial calendar 2020 November 5, 2019 08:00 Regulatory Read more
BioArctic receives MEUR 15 milestone payment from Eisai for start of BAN2401 confirmatory Phase 3 study in early Alzheimer’s Disease May 20, 2019 17:45 Regulatory Read more
BioArctic’s partner Eisai initiates the confirmatory Phase 3 study of BAN2401 in early Alzheimer’s Disease March 22, 2019 00:40 Regulatory Read more
BioArctic announces start of Phase 1 study of ABBV-0805 for Parkinson’s disease March 13, 2019 22:30 Regulatory Read more
BioArctic: Eisai announces timelines for the single confirmatory Phase 3 study with BAN2401 in early Alzheimer’s disease March 7, 2019 08:45 Regulatory Read more
BioArctic’s product candidate SC0806 for treatment of patients with complete spinal cord injury is now in Phase 2 February 13, 2019 08:00 Regulatory Read more
BioArctic: U.S. Food and Drug Administration Approves Investigational New Drug Application for ABBV-0805 February 11, 2019 17:00 Regulatory Read more
BioArctic announces that Eisai will initiate Phase 3 confirmatory study with BAN2401 in early Alzheimer’s Disease February 4, 2019 10:00 Regulatory Read more
BioArctic outlicenses its alpha-synuclein antibody portfolio for Parkinson’s Disease to AbbVie after receiving clearance December 14, 2018 08:00 Regulatory Read more
BioArctic is awarded grant from EU’s Horizon 2020 for participation in research consortium for better diagnostic tools and biomarkers for Parkinson’s November 12, 2018 08:00 Regulatory Read more
BioArctic presents Nomination Committee and publishes financial calendar 2019 November 6, 2018 20:00 Regulatory Read more
BioArctic’s partner AbbVie exercises its option to license the alpha-synuclein antibody portfolio for Parkinson’s Disease November 2, 2018 02:30 Regulatory Read more
BioArctic announces additional BAN2401 Phase 2b study results in early Alzheimer’s disease presented by Eisai at the 2018 CTAD conference October 25, 2018 14:30 Regulatory Read more
BioArctic is granted a concept patent in Europe for the company’s strategy for disease-modifying treatment of Parkinson’s disease October 21, 2018 09:00 Regulatory Read more
BioArctic receives European patent protection for a medical device for treatment of patients with Complete Spinal Cord Injury October 3, 2018 14:30 Regulatory Read more
BioArctic signs a research agreement with Brain Biomarker Solutions in Gothenburg AB to develop new diagnostics for Alzheimer’s disease September 13, 2018 10:00 Regulatory Read more
BioArctic expands the research collaboration with Uppsala University concerning antibody-based diagnostic imaging of the brain in Alzheimer patients September 3, 2018 14:30 Regulatory Read more
BioArctic obtains exclusive rights to develop antibody treatments for Alzheimer’s disease from a research project jointly owned with Eisai August 7, 2018 20:00 Regulatory Read more
BioArctic announces detailed results of the BAN2401 Phase 2b study in early Alzheimer’s disease presented at AAIC 2018 July 25, 2018 22:30 Regulatory Read more
BioArctic: Late breaking Phase 2b study results of BAN2401 in Alzheimer’s disease will be webcast live from AAIC 2018 by Eisai July 18, 2018 22:00 Regulatory Read more
BioArctic receives regulatory approval in Finland for a clinical study in patients with Complete Spinal Cord Injury July 10, 2018 12:30 Regulatory Read more
BioArctic Announces Acceptance of BAN2401 Phase 2b Results for Oral Presentation at the AAIC 2018 July 10, 2018 03:00 Regulatory Read more
BioArctic announces positive topline results of BAN2401 Phase 2b at 18 months in early Alzheimer’s Disease July 6, 2018 01:30 Regulatory Read more
BioArctic announces changes in the Management Team effective September 1, 2018 June 27, 2018 07:00 Regulatory Read more
Report from the Annual General Meeting in BioArctic AB (publ) May 15, 2018 20:00 Regulatory Read more
BioArctic extends the research collaboration with Uppsala University regarding new antibody technology May 14, 2018 10:30 Regulatory Read more
Inclusion completed of patients with complete spinal cord injury in the first panel of BioArctic’s ongoing study April 25, 2018 11:00 Regulatory Read more
BioArctic receives regulatory approval in Norway for a clinical study in patients with Complete Spinal Cord Injury March 21, 2018 13:00 Regulatory Read more
BioArctic receives patent protection in Japan for a medical device for treatment of patients with Complete Spinal Cord Injury March 19, 2018 13:00 Regulatory Read more
BioArctic receives regulatory approval in Estonia for a clinical study in patients with Complete Spinal Cord Injury February 21, 2018 11:00 Regulatory Read more
Invitation to presentation of BioArctic’s Full Year Report 2017 on February 20, 2018 February 5, 2018 17:30 Regulatory Read more
BioArctic receives US patent protection for a method with a medical device for treatment of patients with Complete Spinal Cord Injury February 2, 2018 08:00 Regulatory Read more
BioArctic announces that the Phase 2b study of BAN2401 in early Alzheimer´s Disease continues toward 18 month endpoint December 21, 2017 13:00 Regulatory Read more
BioArctic presents Nomination Committee and publishes financial calendar 2018 November 9, 2017 13:30 Regulatory Read more
Change in the number of shares and votes in BioArctic AB (publ) October 31, 2017 18:00 Regulatory Read more
BioArctic’s patent for its product candidate antibody BAN0805, for Parkinson’s disease, is now granted in Europe October 13, 2017 10:15 Regulatory Read more
