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FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US

Stockholm, January 14, 2025 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic’s partner Eisai’s Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). Leqembi is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a

BioArctic announces global license agreement with Bristol Myers Squibb for BioArctic’s PyroGlutamate-amyloid-beta antibody program

Stockholm, Sweden, December 19, 2024 – 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[TM ]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

First patient dosed in EXIST Phase 2a study in Parkinson’s disease

Stockholm, December 5, 2024 – 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

Leqembi® approved in Mexico

Stockholm, Sweden, December 5, 2024 – 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 (protofibrils[2]), 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

Number of shares and votes in BioArctic AB (publ) as of November 29, 2024

Stockholm, November 29, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company during November issued 14,500 Class B shares for delivery of shares to participants in the 2019/2028 stock option program resolved at the Annual General Meeting on May 9, 2019. The shares were issued through an exercise of 14,500 options of series 2019/2028.As of November 29, 2024, the last trading day of the month, the total number of shares in BioArctic AB amounts to 88,389,035 shares, of which 73,989,039 listed Class B shares and 14,399,996 unlisted Class A shares. The A share

Leqembi[®] launched in South Korea

Stockholm, Sweden, November 28, 2024 – 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

CHMP issues positive recommendation for approval of lecanemab in the EU

Stockholm, November 14, 2024 – 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.The CHMP recommendation for the European Commission to approve lecanemab follows Eisai’s request for a re-

Interim Report for the period July – September 2024

Over 60 percent higher royalties than previous quarterEvents during the third quarter 2024 · Leqembi® received approval and launched in Hong Kong, Israel, United Arab Emirates and Great Britain · The European Medicines Agency (EMA) issued a negative opinion on the Marketing Authorisation Application for lecanemab. BioArctic's partner, Eisai, has requested a re-examination, with EMA’s decision expected shortly · Data from the lecanemab three-year extension study (OLE) demonstrated continued and increasing patient benefit, with a maintained safety profile Events after the end of

Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 – March 2025). Sales now expected to reach JPY 42.5 billion

Stockholm, Sweden, November 8, 2024 – BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today updated their revenue outlook for Leqembi for their 2024 fiscal year (FY), which runs from April 2024 through March 2025. Eisai now expects Leqembi sales to total JPY 42.5 billion (approximately SEK 3 billion) for the period, down from JPY 56.5 billion announced in May. This would generate approximately SEK 300 M in royalty to BioArctic in the same period. Leqembi sales for the first half of Eisai’s FY2024 amounted to JPY 16.3 billion, resulting in SEK 112.4 M in royalty to BioArctic.

BrainTransporter™ dramatically improves antibody delivery to the brain

Stockholm, Sweden, November 6, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has presented the design of its proprietary BrainTransporter (BT) platform at the 16[th] annual Protein & Antibody Engineering Summit (PEGS) conference in Barcelona, Spain. The BT platform uses active Transferrin Receptor (TfR)-mediated transport, enabling up to 70-fold higher penetration of antibodies over the blood brain barrier, without negative effects on hematological safety parameters.During the 16[th] annual Protein & Antibody Engineering Summit (PEGS) Europe conference, Dr. Per-Ola Freskgård, VP

Invitation to presentation of BioArctic’s third quarter report for July - September 2024 on November 14 at 9.30 a.m. CET

Stockholm, Sweden, November 6, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) will publish the company’s third quarter report for July – September 2024 on Thursday, November 14, 2024, at 08:00 a.m. CET.In conjunction to the report, BioArctic invites investors, analysts, and media to an audiocast with teleconference (in English) on November 14, at 09:30 CET, where Gunilla Osswald, CEO, and Anders Martin-Löf, CFO, will present and comment on the third quarter report, followed by a Q&A-session. If you wish to participate via webcast, please use the link below. Via the webcast you

Eisai completes rolling BLA submission for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US

Stockholm, Sweden November 1, 2024 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).

Lecanemab data presented at CTAD on early initiation and long-term treatment suggest increased patient benefit with maintained safety profile

Stockholm, Sweden October 31, 2024 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has presented the latest findings for lecanemab (Leqembi®) at the Clinical Trials on Alzheimer’s Disease, CTAD, congress, held in Madrid, Spain, and virtually, October 29 to November 1. Three-year data show that lecanemab continues to give increased patient benefit for patients with early Alzheimer’s disease, expanding approximately 1 point on CDR-SB compared to the ADNI[1]-population, with maintained safety profile. In addition, data show that 46% of patients who had low levels of brain

Leqembi® revenue totaled JPY 10 billion in the third quarter 2024

Stockholm, Sweden, October 30, 2024 – BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi during the third quarter 2024, in conjunction with their partner Biogen’s quarterly report. In total, sales of JPY 10 billion were recorded in the quarter, an increase of approximately 60% compared to the previous quarter (Q2 2024: JPY 6.3 billion), resulting in a royalty to BioArctic amounting to approximately SEK 70 million.Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and

Professor Lars Lannfelt, awarded the CTAD Lifetime Achievement Award in recognition for his pioneering work in Alzheimer's Disease

Stockholm, Sweden, October 30, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that BioArctic's co-founder, Professor Lars Lannfelt, was awarded the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the Clinical Trials in Alzheimer’s Disease (CTAD) congress in Madrid on October 29. Professor Lannfelt received the award in recognition for his pioneering work in Alzheimer's disease, specifically his scientific discoveries and contribution to drug development.Professor Lannfelt’s groundbreaking research has played a significant role in the

Lifetime Achievement Award, lecanemab and biomarkers in focus at CTAD

Stockholm, October 24, 2024 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) founder Lars Lannfelt will be presented with the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the Clinical Trials for Alzheimer's Disease Conference (CTAD) held in Madrid, Spain, and virtually from October 29 to November 1. Lars Lannfelt will be one of the keynote speakers at the conference. In addition, BioArctic’s partner Eisai present lecanemab data in two oral and one poster presentation at the meeting and three symposia will focus on lecanemab. Data shared will include the

Eisai will request reconsideration of initial decision for lecanemab in Australia

Stockholm, Sweden October 17, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.Eisai will request a reconsideration of this initial decision under Section 60 of the Therapeutic Goods Act within 90 days to make lecanemab

BioArctic presents Nomination Committee

Stockholm, Sweden, October 11, 2024 – Pursuant to the instruction regarding the appointment of the Nomination Committee BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) shall have a Nomination Committee comprising one representative for each of the three principal shareholders in terms of votes, based on the information received from Euroclear Sweden AB on the last banking day in September 2024, as well as the Chairman of the Board (convener).September 30, 2024, the three largest shareholders were Demban AB, Ackelsta AB and The Fourth Swedish National Fund (Fjärde AP-fonden). The three

Number of shares and votes in BioArctic AB (publ) as of September 30, 2024

Stockholm, September 30, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company during September issued 39,050 Class B shares for delivery of shares to participants in the 2019/2028 stock option program resolved at the Annual General Meeting on May 9, 2019. The shares were issued through an exercise of 39,050 options of series 2019/2028.As of September 30, 2024, the last trading day of the month, the total number of shares in BioArctic AB amounts to 88,374,535 shares, of which 73,974,539 listed Class B shares and 14,399,996 unlisted Class A shares. The A

Interim Report for the period April – June 2024

Lecanemab authorised in Great Britain and EU re-examination in progress Events during the second quarter 2024 · BioArctic and Eisai entered into a research evaluation agreement regarding the drug candidate BAN2802 · Eisai received Fast Track designation and initiated a rolling Biologics License Application (BLA) to the FDA for subcutaneous maintenance dosing of Leqembi[®] · Eisai published sales projection for Leqembi for fiscal year 2024 (April 2024 – March 2025) of JPY 56.5 billion · The U.S. Food and Drug Administration (FDA) accepted Eisai’s Supplemental Biologics

Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology

Stockholm, August 27, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the results from two phase-1 studies with exidavnemab have been published in The Journal of Clinical Pharmacology. Exidavnemab is a drug candidate under development aimed at treating diseases such as Parkinson's disease. It is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, while sparing the physiological form of the protein.In two separate phase 1 clinical studies conducted in collaboration with AbbVie, exidavnemab was tested on healthy volunteers to assess

Leqembi (lecanemab) authorized for early Alzheimer’s disease in Great Britain

Stockholm, Sweden August 22, 2024 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi® (brand name, generic name: lecanemab) has been granted Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain, for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)[1] heterozygotes or non-carriers.[2] Lecanemab becomes the first the medicine which targets an underlying cause of the disease, to be authorized in a

Regarding rumors of an imminent approval of lecanemab in Great Britain

Stockholm, Sweden August 22, 2024 – British media are reporting on the imminent approval of lecanemab in Great Britain. BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has currently not been informed that the relevant authorities have made a decision and cannot therefore comment on these rumors. The company will update the market if new information becomes available.--- The information was released for public disclosure, through the agency of the contact persons below, on August 22, 2024, at 08.34 a.m. CET.  For further information, please contact: Oskar Bosson, VP Communications

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