US/UK/Canada

Share

Pick a time period -
Tags ( Active)

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

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

Interim Report for the period January – March 2024

First BrainTransporter technology agreement signed  Events during the first quarter 2024 · Leqembi® was approved for the treatment of Alzheimer's disease in China – launch planned for July 2024 · The European Medicines Agency (EMA) announced that its deliberations on lecanemab regarding the Marketing Authorisation Application has been rescheduled due to procedural reasons Events after the end of the period · BioArctic’s partner Eisai submitted a supplemental Biologics License Application (sBLA) for less frequent intravenous (IV) maintenance dosing with lecanemab to the

Interim Report for the period October – December 2023

Leqembi launched in Japan and approved in China Events during the fourth quarter 2023 · Leqembi was launched in Japan on December 20 which meant that the country was the second market in the world after the USA where the drug is available · Data presented at the CTAD congress further supported Leqembi’s disease modifying characteristics and safety profile as well as the subcutaneous formulation · BioArctic and Eisai have agreed on commercialization and co-promotion for the Nordic countries Events after the end of the period · The European Medicines Agency (EMA)

Interim Report for the period July – September 2023

LEQEMBI launched in the USEvents during the third quarter 2023 · In July, the FDA approved LEQEMBI® for the treatment of Alzheimer’s disease in the US and the Centers for Medicare and Medicaid Services, CMS, announced that LEQEMBI will be reimbursed according to the FDA approved label · In September, LEQEMBI was approved for the treatment of Alzheimer's disease in Japan, which entitled BioArctic to a milestone payment of EUR 17 M, equivalent to SEK 201.0 M · The board has decided to initiate a Phase 2a study of exidavnebab (BAN0805) in Parkinson's disease. The study is expected

Interim Report for the period April – June 2023

LEQEMBI® approved in the US – the world’s first fully approved disease-modifying treatment for Alzheimer’s disease  Events during the second quarter 2023 · The U.S. Food and Drug Administration’s (FDA) Advisory Committee voted unanimously that the data from BioArctic’s partner Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® (US brand name for lecanemab) · Eisai submitted applications for marketing authorization for lecanemab in South Korea and Great Britain · Health Canada initiated the review of New Drug Submission for lecanemab as

Interim Report for the period January – March 2023

Applications for market approval of lecanemab submitted on three continents Events during the first quarter 2023 · On January 6, the FDA approved lecanemab (Leqembi™) via the accelerated approval pathway for the treatment of Alzheimer's disease · BioArctic’s partner Eisai has filed for full approval for lecanemab in the US, EU, Japan and China. The submissions have all been accepted for review with the ones in the US, Japan and China being granted priority review · The Prescription Drug User Fee Act (PDUFA) action date for full approval in the US is July 6, 2023 · The

BioArctic publishes the Annual Report for 2022

Stockholm April 27, 2023 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) hereby announces that the Annual Report for 2022 has been published.The Annual Report, which is attached, can also be downloaded from the company’s website, www.bioarctic.se/en (Investors/Financial reports and presentations).   ---   For further information, please contact:Jan Mattsson, CFO,E-mail: jan.mattsson@bioarctic.sePhone: + 46 70 352 27 72   Oskar Bosson, Vice President Investor Relations & CommunicationsE-mail: oskar.bosson@bioarctic.sePhone: +46 70 410 71 80    This

Interim Report for the period October – December 2022

The US FDA approved Leqembi™ under the accelerated approval pathway for the treatment of Alzheimer's disease Events during the fourth quarter 2022 · Detailed and positive lecanemab data from the Phase 3 study, Clarity AD, were presented by Eisai at the CTAD Alzheimer Congress. The results were simultaneously published in the New England Journal of Medicine · BioArctic started the two new projects, PD-BT2238, a selective antibody against soluble alpha-synuclein aggregates, and GD-BT6822, an enzyme replacement therapy for Gaucher’s disease. Both projects are combined with the

Interim Report for the period July – September 2022

Groundbreaking results for lecanemab in Phase 3 study in early Alzheimer's disease Events during the third quarter 2022 · Lecanemab showed positive results in the pivotal Phase 3 study, Clarity AD, in early Alzheimer's disease, and both primary and all key secondary endpoints were met with high statistical significance · New lecanemab data were presented by Eisai at the Alzheimer's Association International Conference (AAIC), including data on a subcutaneous formulation of lecanemab · The FDA accepted the Biologics License Application (BLA) and granted priority review for

Interim Report for the period April – June 2022

FDA grants priority review for lecanemab marketing application Events during the second quarter 2022 · Eisai completed the rolling submission of lecanemab for treatment of early Alzheimer’s disease to the US Food and Drug Administration (FDA) under the accelerated approval pathway · AbbVie took a strategic business decision to terminate its collaboration with BioArctic regarding its alpha-synuclein projects in Parkinson’s disease. BioArctic is now working with AbbVie to bring back the projects with the intention of finding a new partner   Events after the second quarter

Interim Report for the period January – March 2022

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 assessment consultation, with the objective of obtaining faster regulatory marketing approval. Events after the first quarter · AbbVie took a strategic business decision to end its collaboration with BioArctic regarding its alpha-synuclein portfolio, including ABBV-0805. BioArctic will now, in accordance with the license agreement, take back the project and evaluate the best way forward. · A recently

Interim Report for the period October – December 2021

A time of hope for Alzheimer’s patientsEvents during the fourth quarter 2021 · Lecanemab was granted Fast Track designation by the US Food and Drug Administration (FDA), which is a program that is intended to support and expedite the development of new treatments for serious illnesses with significant medical need, such as Alzheimer’s disease. · The clinical section and proposed label, the second of three parts in the rolling submission for lecanemab under the accelerated approval pathway, was submitted to the FDA. · BioArctic announced that the company’s ND3014 drug project is

Interim Report for the period July – September 2021

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 the US FDA Biologics License Application of lecanemab, under the accelerated approval pathway. The objective is for lecanemab to be approved for the treatment of patients with early Alzheimer’s disease. ·Data from the Phase 2b open-label extension study of lecanemab presented at the Alzheimer’s Association International Conference provided further support for the clinical effects of the drug

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Stockholm, July 30, 2021 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai held several presentations at the Alzheimer’s Association International Conference (AAIC) in Denver, Colorado July 26 to 30, 2021. The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer’s disease, were

Interim Report for the period April – June 2021

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 in Alzheimer’s disease, which is a program intended to facilitate and accelerate the development and review of drugs for serious or life-threatening conditions. Financial summary April – June 2021 · Net revenues for the period amounted to MSEK 7.3 (7.0) · Operating profit amounted to MSEK -33.8 (-37.9) · Profit for the period amounted to MSEK -34.2 (-38.2) and earnings per

Interim Report for the period January – March 2021

New data continues to strengthen lecanemabEvents during the first quarter 2021 · BioArctic presented findings at the AD/PD conference suggesting that lecanemab could be developed into a disease modifying treatment for individuals with Down’s syndrome with dementia. · New preliminary results presented from the ongoing open-label extension of the Phase 2b study in early Alzheimer’s disease continued to support the effect of the drug candidate lecanemab on brain amyloid levels. Events after the period · Lecanemab Phase 2b study results in early Alzheimer’s disease published in

Latest lecanemab data to be presented at the AD/PD™ congress

Stockholm, March 5, 2021 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company and its collaboration partner Eisai will both present data relating to its investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401), at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders, AD/PD™ 2021.The International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders – which due to the ongoing COVID-19 pandemic will be held online – is a key scientific event with a focus

Interim Report for the period January – December 2020

New data provides further support for BAN2401 (lecanemab)Key events during the fourth quarter 2020 · BioArctic’s drug candidate BAN2401 was assigned an international nonproprietary name (INN): lecanemab. · Further data for drug candidate lecanemab (BAN2401) from the Phase 2b open-label extension study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference. Impact of COVID-19 on the company has been limited · The spread and negative effects of the coronavirus during the year had a serious impact on society, the economy and the lives of private

BioArctic receives European patent for new antibodies targeting Alzheimer’s disease

Stockholm, January 27, 2021 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office (EPO) has issued a decision to grant European patent EP 2 448 968 B1 for novel antibodies that could be developed into a treatment for Alzheimer’s disease. The antibodies target a shorter (truncated) form of amyloid beta (pE3-Aβ) and are linked to the company’s project AD1503. The patent enters into force on 27 January 2021 and expires in 2030. BioArctic’s newly granted patent focuses on novel antibodies which target pE3-Ab, a specific truncated form of amyloid

Invitation to presentation of BioArctic’s Full Year Report for the period January - December 2020 on February 4 at 9.30 a.m. CET

Stockholm, Sweden, January 26, 2021 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B)will publish the company’s Full Year Report for the period January – December 2020 onThursday, February 4, 2021, 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 February 4, at 09:30 CET, where Gunilla Osswald, CEO, and Jan Mattsson, CFO, will present BioArctic and comment on the Full Year Report for the period January – December 2020, followed by a Q&A-session. To attend, please dial-in at one of

Eisai presented latest data regarding drug candidate BAN2401 at CTAD 2020

Stockholm, November 9, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today data on the drug candidate BAN2401 (lecanemab), which were presented by the company’s partner Eisai at the Clinical Trials on Alzheimer’s Disease conference (CTAD), November 4-7. The presentations included study design and initial screening results from the Phase 3 study AHEAD 3-45, the baseline characteristics of currently enrolled Alzheimer’s disease patients in the Phase 3 study Clarity AD, and an update on the effect of BAN2401 on amyloid brain levels and the ARIA-E frequency for patients enrolled

BioArctic winner of the Allbright Award 2020

Stockholm, October 15, 2020 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the company has been awarded the 2020 Allbright Award for its focused work with gender equality. The announcement was made on October 15 during Allbright's annual award ceremony in Stockholm. BioArctic is a Swedish research-based biopharmaceutical company focusing on disease-modifying treatments for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. The company is listed on Nasdaq Stockholm Mid Cap and has previously been nominated as a finalist for the

There are no items matching the current filter
There are no more items matching the current filter
Back to top

Subscribe

Media