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Year archive

BioArctic — 2025 filings

All 75 regulatory filings released by BioArctic (BIOA) in 2025, sourced directly from the official regulator.

75 Filings
2025 Period
2025 filings (75)
Filing Released Lang
Number of shares and votes in BioArctic AB (publ) as of November 28, 2025
Share Issue/Capital Change
2025-11-28 English
Antal aktier och röster i BioArctic AB (publ) per den 28 november 2025
Share Issue/Capital Change
2025-11-28 Swedish
Ansökan om marknadsgodkännande för subkutan behandling med Leqembi[®] inlämnad i Japan
Regulatory Filings
2025-11-28 Swedish
New drug application for subcutaneous formulation of Leqembi[®] submitted in Japan
Regulatory Filings
2025-11-28 English
Eisai slutför stegvis ansökan för subkutan initieringsbehandling med Leqembi® Iqlik™ (lecanemab-irmb) i USA
Regulatory Filings
2025-11-25 Swedish
Eisai completes U.S. rolling sBLA submission for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose
Regulatory Filings
2025-11-25 English
Interim / Quarterly Report 2025
Interim / Quarterly Report Q3 2025
2025-11-13 Swedish
Interim / Quarterly Report 2025
Interim / Quarterly Report Q3 2025
2025-11-13 English
Försäljningen av Leqembi® uppgick till 18 miljarder yen under det tredje kvartalet 2025
Earnings Release Q3 2025
2025-10-30 Swedish
Sales of Leqembi® totaled 18 billion yen in the third quarter 2025
Earnings Release Q3 2025
2025-10-30 English
BioArctic presents Nomination Committee
Board/Management Information
2025-10-17 English
BioArctic presenterar valberedningen
Board/Management Information
2025-10-17 Swedish
Kina godkänner intravenös underhållsbehandling med Leqembi®
Regulatory Filings
2025-09-29 Swedish
Leqembi® approved for IV maintenance treatment in China
Regulatory Filings
2025-09-29 English
Leqembi® approved for the treatment of early Alzheimer’s disease in Australia
Regulatory Filings
2025-09-24 English
Australien godkänner Leqembi® för behandling av tidig Alzheimers sjukdom
Regulatory Filings
2025-09-24 Swedish
BioArctics grundare har för avsikt att sälja en mindre del av sitt aktieinnehav
Major Shareholding Notification
2025-09-03 Swedish
BioArctic’s founders intend to divest minor part of their shareholding
Major Shareholding Notification
2025-09-03 English
Rolling sBLA initiated to the U.S. FDA for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under Fast Track status
Regulatory Filings
2025-09-03 English
Stegvis ansökningsprocess påbörjad för marknadsgodkännande i USA av Leqembi® Iqlik™ (lecanemab-irmb) som initial subkutan behandling för tidig Alzheimers sjukdom
Regulatory Filings
2025-09-03 Swedish
Number of shares and votes in BioArctic AB (publ) as of August 29, 2025
Share Issue/Capital Change
2025-09-01 English
Antal aktier och röster i BioArctic AB (publ) per den 29 augusti 2025
Share Issue/Capital Change
2025-09-01 Swedish
Amerikanska läkemedelsverket godkänner subkutan underhållsbehandling med Leqembi® IQKLIK™ (lecanemab-irmb) för tidig Alzheimers sjukdom
Regulatory Filings
2025-08-29 Swedish
US FDA approves Leqembi® IQKLIK ™ (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer’s disease
Regulatory Filings
2025-08-29 English
Interim / Quarterly Report 2025
Interim / Quarterly Report Q2 2025
2025-08-28 Swedish
Interim / Quarterly Report 2025
Interim / Quarterly Report Q2 2025
2025-08-28 English
BioArctic och Novartis ingår options-, samarbets- och licensavtal som nyttjar BrainTransporter™ med initial betalning om 30 miljoner USD samt ytterligare potentiella milstolpar och royalties
M&A Activity
2025-08-26 Swedish
BioArctic and Novartis sign an option, collaboration and license agreement using BrainTransporter™ for an upfront payment of USD 30 million plus additional potential milestones and royalties
M&A Activity
2025-08-26 English
Sales of Leqembi® totaled 23.1 billion yen in the second quarter 2025
Earnings Release Q2 2025
2025-07-31 English
Försäljningen av Leqembi® uppgick till 23,1 miljarder yen under det andra kvartalet 2025
Earnings Release Q2 2025
2025-07-31 Swedish
BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review
Regulatory Filings
2025-06-13 English
BioArctic initierar nästa steg i fas 2a-studien av exidavnemab efter positiv säkerhetsutvärdering
Regulatory Filings
2025-06-13 Swedish
Number of shares and votes in BioArctic AB (publ) as of May 30, 2025
Declaration of Voting Results & Voting Rights Announcements
2025-05-30 English
Antal aktier och röster i BioArctic AB (publ) per den 30 maj 2025
Share Issue/Capital Change
2025-05-30 Swedish
Kommuniké från årsstämma i BioArctic AB (publ)
AGM Information
2025-05-22 Swedish
Bulletin from the Annual General Meeting in BioArctic AB (publ)
AGM Information
2025-05-22 English
BioArctic receives positive opinion for Orphan Medicinal Product Designation in the EU for exidavnemab in Multiple System Atrophy
Regulatory Filings
2025-05-22 English
BioArctic erhåller positiv rekommendation för särläkemedelsklassificering i EU för exidavnemab för multipel systematrofi
Regulatory Filings
2025-05-22 Swedish
Interim / Quarterly Report 2025
Interim / Quarterly Report Q1 2025
2025-05-21 Swedish
Interim / Quarterly Report 2025
Interim / Quarterly Report Q1 2025
2025-05-21 English
Eisai prognosticerar 76,5 miljarder JPY i försäljning av Leqembi® för bolagets brutna räkenskapsår 2025 (april 2025 – mars 2026)
Earnings Release FY 2025
2025-05-15 Swedish
Eisai projects Leqembi® revenue to total JPY 76.5 billion for fiscal year 2025 (April 2025 – March 2026)
Earnings Release FY 2025
2025-05-15 English
Sales of Leqembi[®] totaled 14.7 billion yen in the first quarter 2025
Earnings Release Q1 2025
2025-05-01 English
Försäljningen av Leqembi[®] uppgick till 14,7 miljarder yen under det första kvartalet 2025
Earnings Release Q1 2025
2025-05-01 Swedish
Notice of Annual General Meeting 2025 in BioArctic AB (publ)
AGM Information
2025-04-22 English
Kallelse till årsstämma 2025 i BioArctic AB (publ)
AGM Information
2025-04-22 Swedish
Annual Report (ESEF) 2024
Annual Report (ESEF) FY 2024
2025-04-22 Swedish
Annual Report (ESEF) 2024
Annual Report (ESEF) FY 2024
2025-04-22 Swedish
EU approves Leqembi® (lecanemab) for treatment of early Alzheimer’s disease (Extended information)
Regulatory Filings
2025-04-16 English
EU godkänner Leqembi® (lecanemab) för behandling av tidig Alzheimers sjukdom (Utökad information)
Regulatory Filings
2025-04-16 Swedish
EU godkänner Leqembi® (lecanemab) för behandling av tidig Alzheimers sjukdom
Regulatory Filings
2025-04-15 Swedish
EU approves Leqembi® (lecanemab) for treatment of early Alzheimer’s disease
Regulatory Filings
2025-04-15 English
EU-kommissionen ska fatta finalt beslut om marknadsgodkännande av lecanemab i EU
Regulatory Filings
2025-04-14 Swedish
The European Commission to make final decision on EU Marketing Authorisation for lecanemab
Regulatory Filings
2025-04-14 English
The European Commission refers lecanemab decision to Appeal Committee
Regulatory Filings
2025-04-01 English
EU-kommissionen hänskjuter beslut om lecanemab till omprövningskommittén
Legal Proceedings Report
2025-04-01 Swedish
BioArctics partner Eisai presenterar simulering av framtida försäljning av Leqembi® vid sin årliga presskonferens
Earnings Release FY 2027
2025-03-25 Swedish
BioArctic’s partner Eisai presents sales simulation for Leqembi® at its annual press conference
Regulatory Filings
2025-03-25 English
BioArctic erhåller särläkemedelsklassificering för exidavnemab i USA
Regulatory Filings
2025-03-17 Swedish
BioArctic receives Orphan Drug Designation for exidavnemab the US
Regulatory Filings
2025-03-17 English
Number of shares and votes in BioArctic AB (publ) as of February 28, 2025
Declaration of Voting Results & Voting Rights Announcements
2025-02-28 English
Antal aktier och röster i BioArctic AB (publ) per den 28 februari 2025
Share Issue/Capital Change
2025-02-28 Swedish
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer’s disease in the EU
Regulatory Filings
2025-02-28 English
CHMP bekräftar positiv rekommendation för lecanemab i EU som behandling av tidig Alzheimers sjukdom
Regulatory Filings
2025-02-28 Swedish
BioArctics globala licensavtal med Bristol Myers Squibb för pyroglutamat-amyloid-beta antikroppsprogrammet träder i kraft efter godkänd konkurrensprövning
Regulatory Filings
2025-02-20 Swedish
BioArctic’s global license agreement with Bristol Myers Squibb for PyroGlutamate-amyloid-beta antibody program effective after antitrust clearance and closing
Capital/Financing Update
2025-02-20 English
Leqembi® sales reaches €200 million – first sales milestone achieved
Earnings Release FY 2024
2025-02-18 English
Leqembi® når €200 miljoner i försäljning – första försäljningsmilstolpen uppnådd
Earnings Release FY 2024
2025-02-18 Swedish
Interim / Quarterly Report 2024
Interim / Quarterly Report Q4 2024
2025-02-13 Swedish
Interim / Quarterly Report 2024
Interim / Quarterly Report Q4 2024
2025-02-13 English
Försäljningen av Leqembi® uppgick till 13,3 miljarder yen under det fjärde kvartalet 2024
Earnings Release Q4 2024
2025-02-07 Swedish
Sales of Leqembi® totaled 13.3 billion yen in the fourth quarter 2024
Regulatory Filings
2025-02-07 English
Update on regulatory review of lecanemab for treatment of early Alzheimer’s disease in the European Union
Regulatory Filings
2025-01-31 English
FDA godkänner intravenös underhållsbehandling med Leqembi® (lecanemab-irmb) för tidig Alzheimers sjukdom i USA
Regulatory Filings
2025-01-27 Swedish
FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer’s Disease in the US
Regulatory Filings
2025-01-27 English