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© PR Newswire
19.11.2025
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New data on lecanemab to be presented at CTAD conference
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STOCKHOLM, Nov. 18, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab (Leqembi®) at the Clinical Trials on Alzheimer's Disease (CTAD) conference, being held in San Diego December 1-4. Presentations will include data on long-term treat...
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© PR Newswire
19.11.2025
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New data on lecanemab to be presented at CTAD conference
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STOCKHOLM, Nov. 18, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab (Leqembi®) at the Clinical Trials on Alzheimer's Disease (CTAD) conference, being held in San Diego December 1-4. Presentations will include data on long-term treat...
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© PR Newswire
14.11.2025
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Leqembi® approved for IV maintenance treatment in the United Kingdom
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STOCKHOLM, Nov. 13, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi (lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the Medicines and Healthcare products R...
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Worth to know
20.10.2025
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© PR Newswire
14.11.2025
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Leqembi® approved for IV maintenance treatment in the United Kingdom
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STOCKHOLM, Nov. 13, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi (lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the Medicines and Healthcare products R...
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20.10.2025
© PR Newswire
13.11.2025
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Interim Report for the period July - September 2025: BioArctic
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STOCKHOLM, Nov. 13, 2025 /PRNewswire/ --
Broadening our portfolio with new projects and partnerships
Events during the third quarter 2025
New data on lecanemab were presented...
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13.11.2025
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Interim Report for the period July - September 2025: BioArctic
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STOCKHOLM, Nov. 13, 2025 /PRNewswire/ --
Broadening our portfolio with new projects and partnerships
Events during the third quarter 2025
New data on lecanemab were presented...
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© PR Newswire
04.11.2025
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Invitation to presentation of BioArctic's third quarter report for July - September 2025 on November 13 at 9.30 a.m. CET
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STOCKHOLM, Nov. 4, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) will publish the company's third quarter report for July - September 2025 on Thursday, November 13, 2025, at 08:00 a.m. CET.
In conjunction to the report, BioArctic invites investors, analysts, and media to an a...
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© PR Newswire
04.11.2025
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Invitation to presentation of BioArctic's third quarter report for July - September 2025 on November 13 at 9.30 a.m. CET
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STOCKHOLM, Nov. 4, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) will publish the company's third quarter report for July - September 2025 on Thursday, November 13, 2025, at 08:00 a.m. CET.
In conjunction to the report, BioArctic invites investors, analysts, and media to an a...
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© PR Newswire
30.10.2025
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Sales of Leqembi® totaled 18 billion yen in the third quarter 2025
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STOCKHOLM, Oct. 30, 2025 /PRNewswire/ -- BioArctic AB's (publ) (STO: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi during the third quarter 2025, in conjunction with their partner Biogen's third quarter report. In total, sales of JPY 18 billion were recorded in the period. This...
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© PR Newswire
27.10.2025
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Health Canada Grants Authorization for Leqembi® (lecanemab)
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STOCKHOLM, Oct. 27, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Leqembi® (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment o...
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© PR Newswire
27.10.2025
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Health Canada Grants Authorization for Leqembi® (lecanemab)
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STOCKHOLM, Oct. 26, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Leqembi® (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment o...
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© PR Newswire
14.10.2025
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First patient treated with Leqembi® (lecanemab) in the Nordics
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STOCKHOLM, Oct. 14, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that Leqembi has now been made available at a private clinic in Finland and that the first patient has started treatment. BioArctic copromotes Leqembi with its partner Eisai in the Nordic countries, and this ma...
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20.10.2025
© PR Newswire
14.10.2025
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Leqembi® Iqlik™ (lecanemab-irmb) selected by TIME as one of the best innovations of 2025
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STOCKHOLM, Oct. 14, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi Iqlik, a subcutaneous autoinjector formulation of lecanemab (generic name), for the treatment of Alzheimer's disease has been selected by TIME as one of the 'Best Inventions of 2025...
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© PR Newswire
14.10.2025
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Leqembi® Iqlik™ (lecanemab-irmb) selected by TIME as one of the best innovations of 2025
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STOCKHOLM, Oct. 14, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi Iqlik, a subcutaneous autoinjector formulation of lecanemab (generic name), for the treatment of Alzheimer's disease has been selected by TIME as one of the 'Best Inventions of 2025...
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© PR Newswire
07.10.2025
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Leqembi® Iqlik™ (lecanemab-irmb) maintenance treatment launched in the U.S.
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STOCKHOLM, Oct. 6, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi Iqlik) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients...
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© PR Newswire
07.10.2025
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Leqembi® Iqlik™ (lecanemab-irmb) maintenance treatment launched in the U.S.
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STOCKHOLM, Oct. 6, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi Iqlik) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients...
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© PR Newswire
03.09.2025
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BioArctic's founders intend to divest minor part of their shareholding
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STOCKHOLM, Sept. 3, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA-B) has been made aware that the company's two founders and main shareholders, Lars Lannfelt and Pär Gellerfors, intend to divest a minor part of their respective shareholding.
This information is information that BioArctic AB (publ) is obliged to disclose pursua...
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© PR Newswire
03.09.2025
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BioArctic's founders intend to divest minor part of their shareholding
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STOCKHOLM, Sept. 3, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA-B) has been made aware that the company's two founders and main shareholders, Lars Lannfelt and Pär Gellerfors, intend to divest a minor part of their respective shareholding.
This information is information that BioArctic AB (publ) is obliged to disclose pursua...
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© PR Newswire
03.09.2025
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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
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STOCKHOLM, Sept. 3, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector, as a weekly star...
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© PR Newswire
03.09.2025
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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
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STOCKHOLM, Sept. 2, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector, as a weekly star...
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© PR Newswire
26.08.2025
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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
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STOCKHOLM, Aug. 26, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the company has entered into an option, collaboration and license agreement with Novartis Pharma AG regarding a potential new treatment combining BioArctic's proprietary BrainTransporter technology with an undisclosed target in neurodegene...
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© PR Newswire
26.08.2025
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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
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STOCKHOLM, Aug. 26, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the company has entered into an option, collaboration and license agreement with Novartis Pharma AG regarding a potential new treatment combining BioArctic's proprietary BrainTransporter technology with an undisclosed target in neurodegene...
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© PR Newswire
25.08.2025
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Leqembi® (lecanemab) launched in the EU today
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STOCKHOLM, Aug. 25, 2025 /PRNewswire/ --BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the launch of Leqembi in the EU started in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025. Leqembi received the European Commission (EC) approval in April 2025 as the first therapy that targ...
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© PR Newswire
25.08.2025
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Leqembi® (lecanemab) launched in the EU today
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STOCKHOLM, Aug. 25, 2025 /PRNewswire/ --BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the launch of Leqembi in the EU started in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025. Leqembi received the European Commission (EC) approval in April 2025 as the first therapy that targ...
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© PR Newswire
22.07.2025
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Lecanemab four-year efficacy and safety data to be presented at AAIC 2025
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STOCKHOLM, July 22, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab (Leqembi®), including four-year efficacy and safety data and data on the subcutaneous formulation for maintenance dosing, at the Alzheimer's Association International Conference (AAIC), being held i...
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© PR Newswire
22.07.2025
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Lecanemab four-year efficacy and safety data to be presented at AAIC 2025
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STOCKHOLM, July 22, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab (Leqembi®), including four-year efficacy and safety data and data on the subcutaneous formulation for maintenance dosing, at the Alzheimer's Association International Conference (AAIC), being held i...
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16.07.2025
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The drug discovery research for lecanemab awarded the 9th Bioindustry Award by the Japan Bioindustry Association
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STOCKHOLM, July 16, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the drug discovery research for lecanemab (product name Leqembi®), an antibody indicated for early Alzheimer's disease which was co-developed by Eisai and BioArctic, has received the 9th Bioindustry Award from the Japan Bio...
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16.07.2025
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The drug discovery research for lecanemab awarded the 9th Bioindustry Award by the Japan Bioindustry Association
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STOCKHOLM, July 16, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the drug discovery research for lecanemab (product name Leqembi®), an antibody indicated for early Alzheimer's disease which was co-developed by Eisai and BioArctic, has received the 9th Bioindustry Award from the Japan Bio...
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26.06.2025
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BioArctic: Professor Lars Lannfelt to receive the 2025 Hartwig Piepenbrock-DZNE Prize
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STOCKHOLM, June 26, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that BioArctic's founder, Professor Lars Lannfelt, will receive the 2025 Hartwig Piepenbrock-DZNE Prize for his pioneering contributions to the understanding of Alzheimer's disease and to the development of the drug lecanemab. The prize is pres...
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26.06.2025
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BioArctic: Professor Lars Lannfelt to receive the 2025 Hartwig Piepenbrock-DZNE Prize
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STOCKHOLM, June 26, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that BioArctic's founder, Professor Lars Lannfelt, will receive the 2025 Hartwig Piepenbrock-DZNE Prize for his pioneering contributions to the understanding of Alzheimer's disease and to the development of the drug lecanemab. The prize is pres...
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© PR Newswire
13.06.2025
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BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review
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STOCKHOLM, June 13, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. The EXIST study evaluates exidavnemab, a drug candidate being developed...
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© PR Newswire
13.06.2025
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BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review
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STOCKHOLM, June 13, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. The EXIST study evaluates exidavnemab, a drug candidate being developed...
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© PR Newswire
15.05.2025
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Eisai projects Leqembi® revenue to total JPY 76.5 billion for fiscal year 2025 (April 2025 - March 2026)
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STOCKHOLM, May 15, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that Leqembi sales are expected to total JPY 76.5 billion (approximately SEK 5.1 billion) for their fiscal year (FY) 2025 (April 2025 through March 2026), corresponding to a 73 percent growth compared to the previous year. This w...
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© PR Newswire
15.05.2025
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Eisai projects Leqembi® revenue to total JPY 76.5 billion for fiscal year 2025 (April 2025 - March 2026)
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STOCKHOLM, May 15, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that Leqembi sales are expected to total JPY 76.5 billion (approximately SEK 5.1 billion) for their fiscal year (FY) 2025 (April 2025 through March 2026), corresponding to a 73 percent growth compared to the previous year. This w...
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© PR Newswire
13.05.2025
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Invitation to presentation of BioArctic's first quarter report for January - March 2025 on May 21 at 9.30 a.m. CET
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STOCKHOLM, May 13, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) will publish the company's first quarter report for January - March 2025 on Wednesday, May 21, 2025, 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 May 21, a...
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© PR Newswire
13.05.2025
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Invitation to presentation of BioArctic's first quarter report for January - March 2025 on May 21 at 9.30 a.m. CET
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STOCKHOLM, May 13, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) will publish the company's first quarter report for January - March 2025 on Wednesday, May 21, 2025, 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 May 21, a...
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© PR Newswire
08.05.2025
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Exidavnemab phase 2a study expanded to include MSA patients
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STOCKHOLM, May 8, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that regulatory authorities in Spain in Poland have approved the inclusion of Multiple System Atrophy (MSA) patients for treatment with the alpha-synuclein antibody exidavnemab in the ongoing EXIST Phase 2a study.
The Phase 2a study EXIST (EXIda...
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© PR Newswire
01.04.2025
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The European Commission refers lecanemab decision to Appeal Committee
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STOCKHOLM, April 1, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee.
The final process for the EC decision on lecanemab's Marketing Authorisation A...
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01.04.2025
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The European Commission refers lecanemab decision to Appeal Committee
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STOCKHOLM, April 1, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee.
The final process for the EC decision on lecanemab's Marketing Authorisation A...
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17.03.2025
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BioArctic receives Orphan Drug Designation for exidavnemab the US
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STOCKHOLM, March 17, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment of Multiple System Atrophy (MSA), providing incentives for the development of treatments for rare diseases...
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12.03.2025
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Lars Lannfelt, Pär Gellerfors, and Gunilla Osswald awarded Uppsala University's Innovation and Entrepreneurship Prize
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STOCKHOLM, March 12, 2025 /PRNewswire/ -- Uppsala University announced today that BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) two founders, Lars Lannfelt and Pär Gellerfors, as well as the company's CEO, Gunilla Osswald, have been awarded the university's Innovation and Entrepreneurship Prize for successfully addressing a growing global heal...
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12.03.2025
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Lars Lannfelt, Pär Gellerfors, and Gunilla Osswald awarded Uppsala University's Innovation and Entrepreneurship Prize
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STOCKHOLM, March 12, 2025 /PRNewswire/ -- Uppsala University announced today that BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) two founders, Lars Lannfelt and Pär Gellerfors, as well as the company's CEO, Gunilla Osswald, have been awarded the university's Innovation and Entrepreneurship Prize for successfully addressing a growing global heal...
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28.02.2025
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The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
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STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab (Leqembi®), adopted in November 2024. Follo...
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© PR Newswire
28.02.2025
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The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
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STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab (Leqembi®), adopted in November 2024. Follo...
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20.02.2025
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BioArctic's global license agreement with Bristol Myers Squibb for PyroGlutamate-amyloid-beta antibody program effective after antitrust clearance and closing
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STOCKHOLM, Feb. 20, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that BioArctic and its partner Bristol Myers Squibb (NYSE: BMY) have received clearance from the U.S. Federal Trade Commission (FTC) for BioArctic to out-license its PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program to Bristol Myers Squi...
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20.02.2025
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BioArctic's global license agreement with Bristol Myers Squibb for PyroGlutamate-amyloid-beta antibody program effective after antitrust clearance and closing
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STOCKHOLM, Feb. 20, 2025 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that BioArctic and its partner Bristol Myers Squibb (NYSE: BMY) have received clearance from the U.S. Federal Trade Commission (FTC) for BioArctic to out-license its PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program to Bristol Myers Squi...
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© PR Newswire
18.02.2025
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Leqembi® sales reaches €200 million - first sales milestone achieved
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STOCKHOLM, Feb. 18, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has notified BioArctic that the first sales milestone according to the licensing agreement has been reached. The milestone was reached as sales of Leqembi reached €200 million in Eisai fiscal year 2024 (April 2024 - Match 2025). The event entit...
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© PR Newswire
18.02.2025
BIOA B
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Leqembi® sales reaches €200 million - first sales milestone achieved
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STOCKHOLM, Feb. 18, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has notified BioArctic that the first sales milestone according to the licensing agreement has been reached. The milestone was reached as sales of Leqembi reached €200 million in Eisai fiscal year 2024 (April 2024 - Match 2025). The event entit...
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© PR Newswire
31.01.2025
BIOA B
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Update on regulatory review of lecanemab for treatment of early Alzheimer's disease in the European Union
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STOCKHOLM, Jan. 31, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two additional questions. These questions will now be discussed at the CHMP meeting in February 2025, before the Commis...
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© PR Newswire
31.01.2025
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Update on regulatory review of lecanemab for treatment of early Alzheimer's disease in the European Union
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STOCKHOLM, Jan. 31, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two additional questions. These questions will now be discussed at the CHMP meeting in February 2025, before the Commis...
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© PR Newswire
27.01.2025
BIOA B
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FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
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STOCKHOLM, Jan. 27, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's Supplemental Biologics License Application (sBLA) for Leqembi as a once every four weeks intravenous (IV) maintenance dosing. Leqembi is indicated for the...
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© PR Newswire
27.01.2025
BIOA B
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FDA approves IV maintenance dosing of Leqembi® (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
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STOCKHOLM, Jan. 26, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's Supplemental Biologics License Application (sBLA) for Leqembi as a once every four weeks intravenous (IV) maintenance dosing. Leqembi is indicated for the...
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© PR Newswire
14.01.2025
BIOA B
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FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
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STOCKHOLM, Jan. 14, 2025 /PRNewswire/ --BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of Al...
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© PR Newswire
14.01.2025
BIOA B
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FDA accepts Biologics License Application for subcutaneous maintenance dosing of Leqembi® (lecanemab-irmb) in the US
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STOCKHOLM, Jan. 13, 2025 /PRNewswire/ --BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosingLeqembi is indicated for the treatment of Al...
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© PR Newswire
19.12.2024
BIOA B
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BioArctic announces global license agreement with Bristol Myers Squibb for BioArctic's PyroGlutamate-amyloid-beta antibody program
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STOCKHOLM, Dec. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that it has entered into a global exclusive license agreement with Bristol Myers Squibb (NYSE: BMY) for BioArctic's PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program, including BAN1503 and BAN2803, whereof the latter includes BioArctic's...
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© PR Newswire
19.12.2024
BIOA B
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BioArctic announces global license agreement with Bristol Myers Squibb for BioArctic's PyroGlutamate-amyloid-beta antibody program
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STOCKHOLM, Dec. 19, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that it has entered into a global exclusive license agreement with Bristol Myers Squibb (NYSE: BMY) for BioArctic's PyroGlutamate-amyloid-beta (PyroGlu-Aβ) antibody program, including BAN1503 and BAN2803, whereof the latter includes BioArctic's...
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© PR Newswire
05.12.2024
BIOA B
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First patient dosed in EXIST Phase 2a study in Parkinson's disease
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STOCKHOLM , Dec. 5, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first patient has been dosed with exidavnemab in the EXIST Phase 2a study, in Parkinson's disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, believed to play a role i...
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© PR Newswire
05.12.2024
BIOA B
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First patient dosed in EXIST Phase 2a study in Parkinson's disease
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STOCKHOLM , Dec. 5, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the first patient has been dosed with exidavnemab in the EXIST Phase 2a study, in Parkinson's disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein α-synuclein, believed to play a role i...
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© PR Newswire
05.12.2024
BIOA B
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Leqembi® approved in Mexico
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STOCKHOLM, Dec. 5, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1.
Leqembi selectively binds to soluble amyloid-beta...
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© PR Newswire
05.12.2024
BIOA B
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Leqembi® approved in Mexico
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STOCKHOLM, Dec. 4, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1.
Leqembi selectively binds to soluble amyloid-beta...
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