News & Videos - BIOARCTIC AB [CBOE] - English

Eisai will request reconsideration of initial decision for lecanemab in Australia PR Newswire STOCKHOLM, Oct. 16, 2024 STOCKHOLM , Oct. 16, 2024 /PRNewswire/ -- 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...

Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology PR Newswire STOCKHOLM, Aug. 27, 2024 STOCKHOLM , Aug. 27, 2024 /PRNewswire/ -- 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...

Leqembi (lecanemab) authorized for early Alzheimer's disease in Great Britain PR Newswire STOCKHOLM, Aug. 22, 2024 STOCKHOLM , Aug. 22, 2024 /PRNewswire/ -- 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...

Regarding rumors of an imminent approval of lecanemab in Great Britain: BioArctic PR Newswire STOCKHOLM, Aug. 22, 2024 STOCKHOLM , Aug. 22, 2024 /PRNewswire/ -- 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...

Regarding rumors of an imminent approval of lecanemab in Great Britain: BioArctic PR Newswire STOCKHOLM, Aug. 22, 2024 STOCKHOLM , Aug. 22, 2024 /PRNewswire/ -- 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...

Invitation to presentation of BioArctic's second quarter report for April - June 2024 on August 29 at 9.30 a.m. CET PR Newswire STOCKHOLM, Aug. 19, 2024 STOCKHOLM , Aug. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) will publish the company's second quarter report for April - June 2024 on Thursday, August 29, 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...

Invitation to presentation of BioArctic's second quarter report for April - June 2024 on August 29 at 9.30 a.m. CET PR Newswire STOCKHOLM, Aug. 19, 2024 STOCKHOLM , Aug. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) will publish the company's second quarter report for April - June 2024 on Thursday, August 29, 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...

Leqembi approved for the treatment of Alzheimer's disease in the United Arab Emirates PR Newswire STOCKHOLM, Aug. 13, 2024 STOCKHOLM , Aug. 13, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi ® (lecanemab) for the treatment of Alzheimer's disease (AD). Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or...

Leqembi revenue more than doubled - totaled JPY 6.3 billion in the second quarter 2024 PR Newswire STOCKHOLM, Aug. 1, 2024 STOCKHOLM , Aug. 1, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi ® during the second quarter 2024, in conjunction with their partner Biogen's second quarter report. In total, sales of JPY 6.3 billion were recorded in the period, an increase of more than 120% compared to the...

Leqembi revenue more than doubled - totaled JPY 6.3 billion in the second quarter 2024 PR Newswire STOCKHOLM, Aug. 1, 2024 STOCKHOLM , Aug. 1, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi ® during the second quarter 2024, in conjunction with their partner Biogen's second quarter report. In total, sales of JPY 6.3 billion were recorded in the period, an increase of more than 120% compared to the...

Long-term lecanemab data show increased patient benefit with maintained safety profile PR Newswire STOCKHOLM, July 30, 2024 STOCKHOLM , July 30, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today presented the latest findings for lecanemab (generic name, brand name: Leqembi®). Three-year data show that lecanemab continues to give increased patient benefit for patients with early Alzheimer's disease with maintained safety profile. In addition, data from the...

Eisai will seek re-examination of CHMP opinion för lecanemab PR Newswire STOCKHOLM, July 26, 2024 STOCKHOLM , July 26, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they will request re-examination of the Committee for Medicinal Products for Human Use (CHMP's) negative opinion posted today on the Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer's disease in the EU. "We are surprised and very disappointed...

CHMP has adopted a negative opinion on lecanemab for the EU PR Newswire STOCKHOLM, July 26, 2024 STOCKHOLM , July 26, 2024 /PRNewswire/ -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has today communicated that it has adopted a negative opinion on BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai's Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer's disease. BioArctic is currently consulting Eisai...

Long-term treatment data for lecanemab to be presented at AAIC 2024 PR Newswire STOCKHOLM, July 23, 2024 STOCKHOLM , July 23, 2024 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) today announced that its partner Eisai will present the latest findings on lecanemab (generic name, brand name Leqembi ® ) at the Alzheimer's Association International Conference (AAIC) 2024. The conference will be held in Philadelphia and virtually from July 28 to August 1, 2024 . Data presented will...

Leqembi approved for the treatment of Alzheimer's disease in Israel PR Newswire STOCKHOLM, July 12, 2024 STOCKHOLM , July 12, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that Leqembi® (generic name: lecanemab) has been approved for treatment of Alzheimer's disease (AD) in Israel . Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment...

Leqembi approved for the treatment of Alzheimer's disease in Hong Kong PR Newswire STOCKHOLM, July 11, 2024 STOCKHOLM , July 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the Department of Health in Hong Kong has approved Leqembi® (brand name in Hong Kong : " 樂意保® ", generic name: lecanemab) for treatment of Alzheimer's disease (AD). Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI)...

Leqembi® (lecanemab) launched in China PR Newswire STOCKHOLM, June 28, 2024 STOCKHOLM , June 28, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai today announced today that Leqembi ® (brand name in China : "乐意保 ® " , generic name: lecanemab) has been launched in China . Leqembi received approval in January 2024 as a treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. China is the third country to launch...

FDA accepts filing of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease PR Newswire STOCKHOLM, June 10, 2024 STOCKHOLM , June 10, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV)...

Eisai projects Leqembi® revenue to total JPY 56.5 billion for fiscal year 2024 (April 2024 - March 2025) PR Newswire STOCKHOLM, May 15, 2024 STOCKHOLM , May 15, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ STOCKHOLM : BIOA B) partner Eisai today said that they expect Leqembi sales to total JPY 56.5 billion (approximately SEK 4 billion ) for their fiscal year (FY) 2024 ( April 2024 through March 2025 ). This would generate approximately SEK 360 M in net royalty to BioArctic. In Eisai's...

Eisai projects Leqembi® revenue to total JPY 56.5 billion for fiscal year 2024 (April 2024 - March 2025) PR Newswire STOCKHOLM, May 14, 2024 STOCKHOLM , May 14, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ STOCKHOLM : BIOA B) partner Eisai today said that they expect Leqembi sales to total JPY 56.5 billion (approximately SEK 4 billion ) for their fiscal year (FY) 2024 ( April 2024 through March 2025 ). This would generate approximately SEK 360 M in net royalty to BioArctic. In Eisai's...