CHMP issues positive recommendation for approval of lecanemab in the EU November 14, 2024 17:01 Regulatory Read more
Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 – March 2025). Sales now expected to reach JPY 42.5 billion November 8, 2024 05:00 Regulatory Read more
Eisai completes rolling BLA submission for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US November 1, 2024 00:30 Regulatory Read more
Leqembi® revenue totaled JPY 10 billion in the third quarter 2024 October 30, 2024 11:45 Regulatory Read more
Number of shares and votes in BioArctic AB (publ) as of September 30, 2024 September 30, 2024 18:30 Regulatory Read more
Leqembi (lecanemab) authorized for early Alzheimer’s disease in Great Britain August 22, 2024 11:05 Regulatory Read more
Regarding rumors of an imminent approval of lecanemab in Great Britain August 22, 2024 08:34 Regulatory Read more
Leqembi revenue more than doubled – totaled JPY 6.3 billion in the second quarter 2024 August 1, 2024 12:45 Regulatory Read more
Long-term lecanemab data show increased patient benefit with maintained safety profile July 30, 2024 23:00 Regulatory Read more
Eisai will seek re-examination of CHMP opinion för lecanemab July 26, 2024 13:15 Regulatory Read more
Leqembi approved for the treatment of Alzheimer’s disease in Israel July 12, 2024 01:30 Regulatory Read more
Leqembi approved for the treatment of Alzheimer’s disease in Hong Kong July 11, 2024 01:30 Regulatory Read more
Number of shares and votes in BioArctic AB (publ) as of June 28, 2024 June 28, 2024 18:30 Regulatory Read more
FDA accepts filing of Leqembi[®] (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer’s Disease June 10, 2024 01:30 Regulatory Read more
Leqembi[®] approved for the treatment of Alzheimer’s disease in South Korea May 24, 2024 12:55 Regulatory Read more
Bulletin from the Annual General Meeting in BioArctic AB (publ) May 22, 2024 18:00 Regulatory Read more
Eisai projects Leqembi® revenue to total JPY 56.5 billion for fiscal year 2024 (April 2024 – March 2025) May 15, 2024 05:45 Regulatory Read more
Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for subcutaneous maintenance dosing May 15, 2024 01:30 Regulatory Read more
Leqembi® revenue totaled JPY 2.83 billion in the first quarter 2024 April 24, 2024 12:45 Regulatory Read more
BioArctic and Eisai sign research evaluation agreement regarding BAN2802 April 20, 2024 09:40 Regulatory Read more
Submission of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer’s disease to the U.S. FDA completed April 1, 2024 01:40 Regulatory Read more
Lecanemab deliberations at the CHMP regarding the Marketing Authorisation Application in the EU have been rescheduled due to procedural reasons March 22, 2024 12:30 Regulatory Read more
BioArctic’s partner Eisai presents updated sales simulation for Leqembi® at its annual press conference March 7, 2024 06:30 Regulatory Read more
Number of shares and votes in BioArctic AB (publ) as of February 29, 2024 February 29, 2024 18:30 Regulatory Read more
Sales of Leqembi® totaled 1.1 billion yen in the fourth quarter 2023 February 6, 2024 04:36 Regulatory Read more
The European Medicines Agency’s Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab January 11, 2024 07:00 Regulatory Read more
Leqembi® approved for the treatment of Alzheimer’s disease in China January 9, 2024 09:30 Regulatory Read more
