Press releases – BioArctic

Eisai completes rolling submission to the FDA of lecanemab for early Alzheimer’s disease under the accelerated approval pathway

May 10, 2022 - Regulatory press release

Stockholm, May 10, 2022 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have completed the rolling submission to the U.S. ...

Report from annual general meeting in BioArctic AB (publ)

May 5, 2022 - Regulatory press release

Stockholm, Sweden, May 5, 2022 - BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today held its Annual General Meeting. Due to Covid-19, the Annual General Meeting ...

Interim Report for the period January – March 2022

April 28, 2022 - Regulatory press release

Decision on marketing approval for lecanemab is approaching Events during the first quarter 2022 Eisai commenced submission of lecanemab data in Japan for a prior ...

AbbVie terminates collaboration with BioArctic on alpha-synuclein portfolio

April 20, 2022 - Regulatory press release

Stockholm, April 20, 2022 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has announced that the company’s partner AbbVie has decided to terminate its collaboration with ...

Notice of Annual General Meeting in BioArctic AB (Publ)

April 6, 2022 - Regulatory press release

The Board of BioArctic AB has resolved to convene an Annual General Meeting of shareholders to be held on Thursday, 5 May 2022

BioArctic publishes the Annual Report for 2021

March 31, 2022 - Regulatory press release

Stockholm March 31, 2022 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) hereby announces that the Swedish version of the 2021 Annual Report has been published. ...

The Nomination Committee’s proposal for the election of board members in BioArctic AB

March 9, 2022 - Regulatory press release

Stockholm March 9, 2022 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) hereby announces that the Nomination Committee for BioArctic AB (publ) presents the following proposals ...

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 - Regulatory press release

Stockholm, March 4, 2022 - BioArctic AB:s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) ...

Interim Report for the period October – December 2021

February 3, 2022 - Regulatory press release

A time of hope for Alzheimer’s patients

Lecanemab granted Fast Track designation by the FDA

December 24, 2021 - Regulatory press release

Stockholm, December 24, 2021 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for ...

BioArctic presents Nomination Committee

November 1, 2021 - Regulatory press release

Stockholm, Sweden, November 1, 2021 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) Annual General Meeting on May 6, 2021, adopted an instruction regarding the appointment ...

Interim Report for the period July – September 2021

October 21, 2021 - Regulatory press release

Eisai initiates Biologics License Application of lecanemab in the US earlier than expected Events during the third quarter 2021 Eisai has initiated a rolling submission for ...

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 - Regulatory press release

Stockholm, September 28, 2021 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that they have initiated a rolling submission to the U.S. ...

Interim Report for the period April – June 2021

July 9, 2021 - Regulatory press release

FDA grants Breakthrough Therapy designation for lecanemab Events during the second quarter 2021 The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for lecanemab ...

FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer’s disease

June 23, 2021 - Regulatory press release

Stockholm, 23 June 2021 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted ...

Report from annual general meeting in BioArctic AB (publ)

May 6, 2021 - Regulatory press release

Stockholm, Sweden, May 6, 2021 - BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today held its Annual General Meeting. Due to the continued spread of the ...

Interim Report for the period January – March 2021

April 21, 2021 - Regulatory press release

New data continues to strengthen lecanemab

Notice of Annual General Meeting in BioArctic AB (publ)

April 7, 2021 - Regulatory press release

The shareholders in BioArctic AB (publ), corporate identity number 556601-2679 (the “Company” or “BioArctic”) are hereby summoned to the Annual General Meeting to be held on ...

BioArctic publishes the Annual Report for 2020

March 31, 2021 - Regulatory press release

Stockholm March 31, 2021 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) hereby announces that the Swedish version of the 2020 Annual Report has been published.

The Nomination Committee’s proposal for the election of board members in BioArctic AB

February 12, 2021 - Regulatory press release

Stockholm February 12, 2021 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) hereby announces that the Nomination Committee for BioArctic AB (publ) presents the following proposals ...

Interim Report for the period January – December 2020

February 4, 2021 - Regulatory press release

New data provides further support for BAN2401 (lecanemab)

Interim Report for the period January – September 2020

October 14, 2020 - Regulatory press release

An additional Phase 3 study in Alzheimer’s disease

BioArctic presents Nomination Committee

October 13, 2020 - Regulatory press release

BioArctic presents Nomination Committee Stockholm, Sweden, October 13, 2020 – BioArctic's Annual General Meeting on May 7, 2020, adopted an instruction regarding the appointment of the Nomination ...

Interim Report for the period January – June 2020

July 10, 2020 - Regulatory press release

Continued performance according to plan Key events during the second quarter 2020 BioArctic communicated that the mechanism of action for the AD1801 antibody project is ...

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 - Regulatory press release

Stockholm, Sweden, July 1, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) to publish the company’s Interim Report for the period January – June ...

Members of BioArctic’s Board of Directors and management increase their shareholdings

May 26, 2020 - Regulatory press release

Stockholm, Sweden, May 26, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announces that seven members of the company's Board and management today have ...

Report from Annual General Meeting in BioArctic (publ)

May 7, 2020 - Regulatory press release

Stockholm, Sweden, May 7, 2020 - BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today held its Annual General Meeting. The following resolutions were adopted. Adoption ...

Interim Report for the period January – March 2020

April 22, 2020 - Regulatory press release

Operations performing according to plan Key events during the first quarter 2020 As of today, BioArctic has not experienced any noteworthy disruptions to its operations ...

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 - Regulatory press release

Stockholm, Sweden, April 15, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) to publish the company’s Interim Report for the period January – March 2020 ...

Notice of Annual General Meeting in BioArctic AB (Publ)

April 7, 2020 - Regulatory press release

The Board of BioArctic AB has resolved to convene an Annual General Meeting of shareholders to be held on Thursday, 7 May 2020 More information about ...

BioArctic publishes the Annual Report for 2019

April 2, 2020 - Regulatory press release

Stockholm April 2, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) hereby announces that the Annual Report for the 2019 has been published in ...

The Nomination Committee’s proposal for the election of board members in BioArctic AB

March 24, 2020 - Regulatory press release

Stockholm March 24, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announces that the Nomination Committee for BioArctic AB provides the following proposals for ...

Full Year Report for the period January – December 2019

February 6, 2020 - Regulatory press release

Enhanced project portfolio from a successful year

BioArctic announces research collaboration with Eisai regarding BAN2401

December 17, 2019 - Regulatory press release

Stockholm, Sweden, December 17, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today the initiation of a research collaboration with Eisai aimed at ...

BioArctic’s partner Eisai presents data from the ongoing BAN2401 Phase 2b extension study in early Alzheimer’s disease

December 5, 2019 - Regulatory press release

Stockholm, Sweden, December 5, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that data from the ongoing BAN2401 Phase 2b open-label extension study ...

BioArctic announces results from interim analysis of the Phase 1/2 study of SC0806 in patients with complete spinal cord injury

November 18, 2019 - Regulatory press release

Stockholm, Sweden, November 18, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today the results of an interim analysis of a Phase 1/2 study ...

BioArctic presents Nomination Committee and publishes financial calendar 2020

November 5, 2019 - Regulatory press release

Stockholm, Sweden, November 5, 2019 – The Annual General Meeting of BioArctic AB on May 9, 2019, adopted instructions regarding the appointment of the Nomination Committee. ...

Interim Report January – September 2019

October 24, 2019 - Regulatory press release

BioArctic: Strong continued progress year to date Summary of key events for the third quarter 2019 BioArctic and Eisai presented new data regarding BAN2401 at ...

Interim Report January – June 2019

July 11, 2019 - Regulatory press release

BioArctic: Significant progress in the projects and additional milestone payment

BioArctic receives MEUR 15 milestone payment from Eisai for start of BAN2401 confirmatory Phase 3 study in early Alzheimer’s Disease

May 20, 2019 - Regulatory press release

Stockholm, Sweden, May 20, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company will receive a milestone payment of MEUR ...

BioArctic – report from the Annual General Meeting 2019

May 9, 2019 - Regulatory press release

Stockholm, Sweden, May 9, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today held its Annual General Meeting 2019. The following resolutions were adopted:

Interim Report January – March 2019

May 9, 2019 - Regulatory press release

BioArctic’s partner Eisai initiated Phase 3-study with BAN2401 in Alzheimer’s disease. Phase 1-study with ABBV-0805 in the Parkinson program started

BioArctic publishes the Annual Report for 2018

April 16, 2019 - Regulatory press release

Stockholm, Sweden, April 16, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the Annual Report for the 2018 fiscal year has been ...

Notice of Annual General Meeting in BioArctic AB (publ)

April 10, 2019 - Regulatory press release

The shareholders in BioArctic AB (publ), corporate identity number 556601-2679 (”the Company”) are hereby summoned to the Annual General Meeting to be held on May 9, ...

BioArctic’s partner Eisai initiates the confirmatory Phase 3 study of BAN2401 in early Alzheimer’s Disease

March 22, 2019 - Regulatory press release

Stockholm, Sweden, March 22, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that its partner Eisai has initiated the global Phase 3 confirmatory ...

BioArctic – Statement regarding today’s trading halt

March 21, 2019 - Regulatory press release

Stockholm, Sweden, March 21, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) comments on the decision today by Nasdaq Stockholm to halt trading in BioArctic ...

BioArctic announces start of Phase 1 study of ABBV-0805 for Parkinson’s disease

March 13, 2019 - Regulatory press release

Stockholm, Sweden, March 13, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first clinical study with ABBV-0805 has started in the ...

BioArctic: Eisai announces timelines for the single confirmatory Phase 3 study with BAN2401 in early Alzheimer’s disease

March 7, 2019 - Regulatory press release

Stockholm, Sweden, March 7, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) informs that Eisai today announced the timelines for the single confirmatory Phase 3 ...

Full Year Report January – December 2018

February 14, 2019 - Regulatory press release

BioArctic’s partner Eisai will initiate BAN2401 confirmatory Phase 3-study in early Alzheimer’s disease. AbbVie in-licensed the Parkinson portfolio

BioArctic’s product candidate SC0806 for treatment of patients with complete spinal cord injury is now in Phase 2

February 13, 2019 - Regulatory press release

Stockholm, Sweden, February 13, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first patient in the second panel of the Phase ...

BioArctic: U.S. Food and Drug Administration Approves Investigational New Drug Application for ABBV-0805

February 11, 2019 - Regulatory press release

ABBV-0805 is being evaluated as a potential disease modifying treatment for Parkinson’s Disease Stockholm, Sweden, February 11, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA ...

BioArctic announces that Eisai will initiate Phase 3 confirmatory study with BAN2401 in early Alzheimer’s Disease

February 4, 2019 - Regulatory press release

Stockholm, Sweden, February 4, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that Eisai stated at their Q3 FY2018 Financial Results Meeting on ...

BioArctic outlicenses its alpha-synuclein antibody portfolio for Parkinson’s Disease to AbbVie after receiving clearance

December 14, 2018 - Regulatory press release

Stockholm, Sweden, December 14, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that BioArctic and its partner AbbVie (NYSE: ABBV) have received U.S. ...

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 - Regulatory press release

Stockholm, Sweden, November 12, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has been awarded a grant from EU’s research and innovation program Horizon 2020. ...

Interim Report January – September 2018

November 8, 2018 - Regulatory press release

BioArctic reports strong BAN2401 Phase 2b results for Alzheimer patients. AbbVie exercises its option to a license for Parkinson’s projects

BioArctic presents Nomination Committee and publishes financial calendar 2019

November 6, 2018 - Regulatory press release

Stockholm, Sweden, November 6, 2018 – According to the resolution of the Annual General Meeting in BioArctic AB (publ) on May 15, 2018 the members of ...

BioArctic’s partner AbbVie exercises its option to license the alpha-synuclein antibody portfolio for Parkinson’s Disease

November 2, 2018 - Regulatory press release

Stockholm, Sweden, November 2, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received a Notice of Option Exercise ...

BioArctic announces additional BAN2401 Phase 2b study results in early Alzheimer’s disease presented by Eisai at the 2018 CTAD conference

October 25, 2018 - Regulatory press release

Stockholm, Sweden, October 25, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) previously announced on July 6, 2018 the positive topline results from the clinical ...

BioArctic is granted a concept patent in Europe for the company’s strategy for disease-modifying treatment of Parkinson’s disease

October 21, 2018 - Regulatory press release

Stockholm, Sweden, October 21, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office (EPO) has issued a decision to ...

BioArctic receives European patent protection for a medical device for treatment of patients with Complete Spinal Cord Injury

October 3, 2018 - Regulatory press release

Stockholm, Sweden, October 3, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office (EPO) has issued a decision to ...

BioArctic signs a research agreement with Brain Biomarker Solutions in Gothenburg AB to develop new diagnostics for Alzheimer’s disease

September 13, 2018 - Regulatory press release

Stockholm, Sweden, September 13, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has signed a research agreement with Brain Biomarker Solutions in Gothenburg AB (BBS). ...

BioArctic expands the research collaboration with Uppsala University concerning antibody-based diagnostic imaging of the brain in Alzheimer patients

September 3, 2018 - Regulatory press release

Stockholm, Sweden, September 3, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that the company has signed an expanded research collaboration agreement with ...

Interim Report January – June 2018

August 23, 2018 - Regulatory press release

Positive results of the BAN2401 Phase 2b study in early Alzheimer’s disease April – June 2018 Net revenues for the period amounted to SEK 52.3 ...

BioArctic obtains exclusive rights to develop antibody treatments for Alzheimer’s disease from a research project jointly owned with Eisai

August 7, 2018 - Regulatory press release

Stockholm, Sweden, August 7, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has in collaboration with Eisai identified a completely new biological target, which provides ...

BioArctic announces detailed results of the BAN2401 Phase 2b study in early Alzheimer’s disease presented at AAIC 2018

July 25, 2018 - Regulatory press release

Stockholm, Sweden, July 25, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced on July 6 the positive topline results from the clinical Phase ...

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 - Regulatory press release

Stockholm, Sweden, July 18, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B). As previously announced, the BAN2401 Phase 2b clinical study results will be presented ...

BioArctic receives regulatory approval in Finland for a clinical study in patients with Complete Spinal Cord Injury

July 10, 2018 - Regulatory press release

Stockholm, Sweden, July 10, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by Fimea, the Finnish Medicines ...

BioArctic Announces Acceptance of BAN2401 Phase 2b Results for Oral Presentation at the AAIC 2018

July 10, 2018 - Regulatory press release

Stockholm, Sweden, July 10, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announces today the results of the BAN2401 Phase 2b clinical study (ClinicalTrials.gov identifier ...

BioArctic announces positive topline results of BAN2401 Phase 2b at 18 months in early Alzheimer’s Disease

July 6, 2018 - Regulatory press release

The full 18 month analysis of the 856 patient BAN2401 Phase 2b clinical study in early Alzheimer’s disease demonstrated statistically significant and dose-dependent slowing in ...

BioArctic announces changes in the Management Team effective September 1, 2018

June 27, 2018 - Regulatory press release

Stockholm, Sweden, June 27, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that professor Lars Lannfelt resumes his employment in the company as ...

Report from the Annual General Meeting in BioArctic AB (publ)

May 15, 2018 - Regulatory press release

BioArctic AB (publ) held its Annual General Meeting on Tuesday May 15, 2018. The following resolutions were adopted:

BioArctic extends the research collaboration with Uppsala University regarding new antibody technology

May 14, 2018 - Regulatory press release

Stockholm, Sweden, May 14, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the company has signed an extended research collaboration agreement with ...

Interim Report January – March 2018

April 26, 2018 - Regulatory press release

Continued progress of the project portfolio January - March 2018 Net sales for the period amounted to SEK 52.3 million (26.2) Operating profit amounted to SEK ...

Inclusion completed of patients with complete spinal cord injury in the first panel of BioArctic’s ongoing study

April 25, 2018 - Regulatory press release

Stockholm, Sweden, April 25, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the inclusion of patients with complete spinal cord injury in ...

BioArctic publishes the Annual Report for 2017

April 24, 2018 - Regulatory press release

Stockholm, Sweden, April 24, 2018 – BioArctic AB (publ.) (Nasdaq Stockholm: BIOA B) announced today that the Annual Report for the 2017 fiscal year has ...

NOTICE OF ANNUAL GENERAL MEETING IN BIOARCTIC AB (PUBL)

April 13, 2018 - Regulatory press release

The shareholders in BioArctic AB (publ), corporate identity number 556601-2679, (”the Company”) are hereby summoned to the Annual General Meeting to be held on Tuesday, ...

BioArctic receives regulatory approval in Norway for a clinical study in patients with Complete Spinal Cord Injury

March 21, 2018 - Regulatory press release

Stockholm, Sweden, March 21, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by the Norwegian Medicines Agency ...

BioArctic receives patent protection in Japan for a medical device for treatment of patients with Complete Spinal Cord Injury

March 19, 2018 - Regulatory press release

Stockholm, Sweden, March 19, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the Japanese Patent Office (JPO) issued a notification to grant ...

BioArctic receives regulatory approval in Estonia for a clinical study in patients with Complete Spinal Cord Injury

February 21, 2018 - Regulatory press release

Stockholm, Sweden, February 21, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has received approval by the Estonian State Agency ...

Full Year Report January – December 2017

February 20, 2018 - Regulatory press release

Successful IPO and continued positive result for BioArctic. October – December 2017. Net sales for the period amounted to SEK 51.0 million (94.4). Operating profit amounted ...

Invitation to presentation of BioArctic’s Full Year Report 2017 on February 20, 2018

February 5, 2018 - Regulatory press release

Stockholm, Sweden, February 5, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) to publish the company’s Full Year Report 2017 for the period January – ...

BioArctic receives US patent protection for a method with a medical device for treatment of patients with Complete Spinal Cord Injury

February 2, 2018 - Regulatory press release

Stockholm, Sweden, February 2, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US Patent and Trademark Office (USPTO) published an Issue ...

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