Year archive

BioArctic — 2024 filings

All 75 regulatory filings released by BioArctic (BIOA) in 2024, sourced directly from the official regulator.

75 Filings

2024 Period

2024 filings (75)

Filing	Released	Lang
BioArctic announces global license agreement with Bristol Myers Squibb for BioArctic’s PyroGlutamate-amyloid-beta antibody program Regulatory Filings	2024-12-19	English
BioArctic och Bristol Myers Squibb ingår globalt licensavtal för BioArctics pyroglutamat-amyloid-beta antikroppsprogram Regulatory Filings	2024-12-19	Swedish
Antal aktier och röster i BioArctic AB (publ) per den 29 november 2024 Share Issue/Capital Change	2024-11-29	Swedish
Number of shares and votes in BioArctic AB (publ) as of November 29, 2024 Share Issue/Capital Change	2024-11-29	English
CHMP issues positive recommendation for approval of lecanemab in the EU Regulatory Filings	2024-11-14	English
CHMP ger positiv rekommendation för godkännande av lecanemab i EU Regulatory Filings	2024-11-14	Swedish
Interim / Quarterly Report 2024 Interim / Quarterly Report Q3 2024	2024-11-14	Swedish
Interim / Quarterly Report 2024 Interim / Quarterly Report 9M 2024	2024-11-14	English
Eisai uppdaterar försäljningsprognosen för Leqembi® till 42,5 miljarder JPY för räkenskapsåret 2024 (april 2024 – mars 2025) Earnings Release FY 2024	2024-11-08	Swedish
Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 – March 2025). Sales now expected to reach JPY 42.5 billion Earnings Release FY 2024	2024-11-08	English
Eisai completes rolling BLA submission for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US Regulatory Filings	2024-11-01	English
Eisai slutför stegvis ansökan för subkutan underhållsbehandling med Leqembi® (lecanemab-irmb) i USA Regulatory Filings	2024-11-01	Swedish
Leqembi® revenue totaled JPY 10 billion in the third quarter 2024 Earnings Release Q3 2024	2024-10-30	English
Försäljningen av Leqembi® uppgick till 10 miljarder yen under det tredje kvartalet 2024 Earnings Release Q3 2024	2024-10-30	Swedish
BioArctic presenterar valberedningen Regulatory Filings	2024-10-11	Swedish
BioArctic presents Nomination Committee Board/Management Information	2024-10-11	English
Antal aktier och röster i BioArctic AB (publ) per den 30 september 2024 Share Issue/Capital Change	2024-09-30	Swedish
Number of shares and votes in BioArctic AB (publ) as of September 30, 2024 Share Issue/Capital Change	2024-09-30	English
Interim / Quarterly Report 2024 Interim / Quarterly Report Q2 2024	2024-08-29	Swedish
Interim / Quarterly Report 2024 Interim / Quarterly Report Q2 2024	2024-08-29	English
Leqembi (lecanemab) authorized for early Alzheimer’s disease in Great Britain Regulatory Filings	2024-08-22	English
Leqembi (lecanemab) godkänt i Storbritannien för behandling av tidig Alzheimers sjukdom Regulatory Filings	2024-08-22	Swedish
Regarding rumors of an imminent approval of lecanemab in Great Britain Regulatory Filings	2024-08-22	English
Försäljningen av Leqembi mer än dubblades – uppgick till 6,3 miljarder yen under det andra kvartalet 2024 Earnings Release Q2 2024	2024-08-01	Swedish
Leqembi revenue more than doubled – totaled JPY 6.3 billion in the second quarter 2024 Earnings Release Q2 2024	2024-08-01	English
Long-term lecanemab data show increased patient benefit with maintained safety profile Earnings Release FY 2024	2024-07-30	English
Långtidsdata för lecanemab visar ökande patientnytta med bibehållen säkerhetsprofil Earnings Release FY 2024	2024-07-30	Swedish
Eisai ansöker om omprövning av CHMP-besked gällande lecanemab Legal Proceedings Report	2024-07-26	Swedish
Eisai will seek re-examination of CHMP opinion för lecanemab Legal Proceedings Report	2024-07-26	English
CHMP lämnar negativ rekommendation avseende lecanemab i EU Regulatory Filings	2024-07-26	Swedish
CHMP has adopted a negative opinion on lecanemab for the EU Regulatory Filings	2024-07-26	English
Leqembi approved for the treatment of Alzheimer’s disease in Israel Regulatory Filings	2024-07-12	English
Leqembi godkänt för behandling av Alzheimers sjukdom i Israel Regulatory Filings	2024-07-12	Swedish
Leqembi approved for the treatment of Alzheimer’s disease in Hong Kong Regulatory Filings	2024-07-11	English
Leqembi godkänt för behandling av Alzheimers sjukdom i Hong Kong Regulatory Filings	2024-07-11	Swedish
Number of shares and votes in BioArctic AB (publ) as of June 28, 2024 Declaration of Voting Results & Voting Rights Announcements	2024-06-28	English
Antal aktier och röster i BioArctic AB (publ) per den 28 juni 2024 Share Issue/Capital Change	2024-06-28	Swedish
Leqembi[®] (lecanemab) launched in China Regulatory Filings	2024-06-28	English
Leqembi[®] (lecanemab) lanserat i Kina Regulatory Filings	2024-06-28	Swedish
FDA accepterar tilläggsansökan för månatlig intravenös underhållsbehandling av tidig Alzheimers sjukdom med Leqembi[®] Regulatory Filings	2024-06-10	Swedish
FDA accepts filing of Leqembi[®] (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer’s Disease Regulatory Filings	2024-06-10	English
Leqembi[®] godkänt för behandling av Alzheimers sjukdom i Sydkorea Regulatory Filings	2024-05-24	Swedish
Leqembi[®] approved for the treatment of Alzheimer’s disease in South Korea Regulatory Filings	2024-05-24	English
Bulletin from the Annual General Meeting in BioArctic AB (publ) AGM Information	2024-05-22	English
Kommuniké från årsstämma i BioArctic AB (publ) AGM Information	2024-05-22	Swedish
Earnings Release 2024 Earnings Release Q1 2024	2024-05-17	Swedish
Interim / Quarterly Report 2024 Interim / Quarterly Report Q1 2024	2024-05-17	English
Eisai förväntar sig att försäljningen av Leqembi® kommer uppgå till 56,5 miljarder JPY under bolagets fiskala år 2024 (april 2024 – mars 2025) Earnings Release FY 2024	2024-05-15	Swedish
Eisai projects Leqembi® revenue to total JPY 56.5 billion for fiscal year 2024 (April 2024 – March 2025) Regulatory Filings	2024-05-15	English
Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for subcutaneous maintenance dosing Regulatory Filings	2024-05-15	English
Eisai påbörjar stegvis ansökan till FDA för subkutan underhållsbehandling med Leqembi® (lecanemab-irmb) Regulatory Filings	2024-05-15	Swedish
Försäljningen av Leqembi® uppgick till 2,83 miljarder yen under det första kvartalet 2024 Earnings Release Q1 2024	2024-04-24	Swedish
Leqembi® revenue totaled JPY 2.83 billion in the first quarter 2024 Earnings Release Q1 2024	2024-04-24	English
BioArctic and Eisai sign research evaluation agreement regarding BAN2802 Regulatory Filings	2024-04-20	English
BioArctic och Eisai ingår forskningsutvärderingsavtal avseende BAN2802 Regulatory Filings	2024-04-20	Swedish
Kallelse årsstämma 2024 BioArctic AB (publ) AGM Information	2024-04-19	Swedish
Notice of Annual General Meeting in BioArctic AB (publ) AGM Information	2024-04-19	English
Annual Report (ESEF) 2023 Annual Report (ESEF) FY 2023	2024-04-18	Swedish
Submission of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer’s disease to the U.S. FDA completed Regulatory Filings	2024-04-01	English
Tilläggsansökan för intravenös underhållsbehandling av tidig Alzheimers sjukdom med Leqembi® inlämnad till FDA Regulatory Filings	2024-04-01	Swedish
CHMPs överläggningar angående ansökan om marknadsföringstillstånd för lecanemab i EU har senarelagts på grund av processkäl Legal Proceedings Report	2024-03-22	Swedish
Lecanemab deliberations at the CHMP regarding the Marketing Authorisation Application in the EU have been rescheduled due to procedural reasons Regulatory Filings	2024-03-22	English
BioArctics partner Eisai presenterar uppdaterad simulering av framtida försäljning av Leqembi® vid sin årliga presskonferens Report Publication Announcement	2024-03-07	Swedish
BioArctic’s partner Eisai presents updated sales simulation for Leqembi® at its annual press conference Earnings Release FY 2026	2024-03-07	English
Antal aktier och röster i BioArctic AB (publ) per den 29 februari 2024 Declaration of Voting Results & Voting Rights Announcements	2024-02-29	Swedish
Number of shares and votes in BioArctic AB (publ) as of February 29, 2024 Share Issue/Capital Change	2024-02-29	English
Interim / Quarterly Report 2023 Interim / Quarterly Report Q4 2023	2024-02-14	Swedish
Interim / Quarterly Report 2023 Interim / Quarterly Report Q4 2023	2024-02-14	English
Försäljningen av Leqembi® uppgick till 1,1 miljarder yen under det fjärde kvartalet 2023 Earnings Release Q4 2023	2024-02-06	Swedish
Sales of Leqembi® totaled 1.1 billion yen in the fourth quarter 2023 Earnings Release Q4 2024	2024-02-06	English
Declaration of Voting Results & Voting Rights Announcements 2024 Declaration of Voting Results & Voting Rights Announcements	2024-01-25	English
Europeiska läkemedelsmyndighetens vetenskapliga rådgivande grupp kommer att diskutera ansökan om marknadsgodkännande för lecanemab Regulatory Filings	2024-01-11	Swedish
The European Medicines Agency’s Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab Legal Proceedings Report	2024-01-11	English
Leqembi® approved for the treatment of Alzheimer’s disease in China Regulatory Filings	2024-01-09	English
Leqembi® godkänt för behandling av Alzheimers sjukdom i Kina Regulatory Filings	2024-01-09	Swedish

Filings by year

2026 24 filings
2025 75 filings
2024 75 filings
2023 59 filings
2022 36 filings
2021 23 filings
2020 26 filings
2019 40 filings
2018 63 filings
2017 13 filings