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BioArctic receives Orphan Drug Designation for exidavnemab the US
i går kl. 18:25 ∙ Cision
Stockholm, March 17, 2025 - 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 with a high medical need. Multiple System Atrophy (MSA) is a rapidly progressive and fatal rare disease affecting the central and autonomic nervous systems. MSA is characterized by pathological alpha-synuclein aggregation, that causes gradual damage to nerve cells in the brain. This affects balance, movement and the autonomic nervous system, which controls several basic functions, such as breathing, digestion and bladder control. Currently there is no cure and no available treatment to slow its progression.
Exidavnemab is being developed as a novel disease-modifying treatment for synucleinopathies such as MSA and Parkinson’s disease. It is a monoclonal antibody (mAb) that selectively targets soluble alpha-synuclein aggregates, such as oligomers or protofibrils. By promoting the clearance of aggregated alpha-synuclein, exidavnemab may reduce the spreading and the negative effects of alpha-synuclein. Thereby, neuronal function and survival may be preserved, and disease progression ultimately slowed down.
Kommentar: Kan ikke se at Bioarctic har noen trials gående i MSA, men de kjører altså en liten fase II med exidavnemab i Parkinsons, som vel vil lese av en eller annen gang neste år. Dette er altså drugen som tidligere var utlisensiert til AbbVie, men sistnevnte avsluttet arbeidet av “strategiske årsaker” eller noe tilsvarende vagt. Ble kun kjørt en fase I, så vanskelig å si noe vesentlig, bortsett fra at drugen virker å være vel tolerert.
10 mill Euro i milepælsutbetaling.
Ikke voldsomt, men det går da rett vei med BioArctic.
Stockholm, Sweden, April 1, 2025 - 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.
Kan jo ha i bakhodet at CHMP for et par uker siden unnlot å godkjenne Kisunla (amerikanske Eli Lillys sin donanemab, som foreløpig er eneste konkurrent til lecanemab). Dette var forsåvidt også caset med lecanemab i fjor sommer. LLY har anket til CHMP, så får vi se hva avgjørelsen blir til slutt.
BioArctic har forresten også retten til å kommersialisere lecanemab i Norden, dette blir vel nå mulig å gjennomføre pga EU-godkjenningen.
Endelig ble det godkjent et amyloiddrug. Blir spennende å se hvor mange som vil bli behandlet. Jobbet faktisk med aducanumab. Krever at man er dyktig på å stillle tidlig diagnose på MCI og mild demens-stadiet. Det er klart at å oppdaget farlig hjerneødem (ARIA-E og ARIA-H) med jevnlig MR etc også krever mye ressurser.
Stockholm, den 1 maj 2024 - BioArctic AB:s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai publicerade idag preliminära globala försäljningssiffror för Leqembi för det första kvartalet 2025, i samband med deras parter Biogens kvartalsrapport. Totalt registrerades en försäljning om 14,7 miljarder yen under perioden. Detta resulterar i en royalty till BioArctic på 101,7 miljoner kronor, vilket motsvarar en ökning på cirka 380 procent jämfört med den royality som erhölls av BioArctic under Q1 2024.
La ut litt nyheter siden sist.
Rapport imorgen, kommer til å få et resultat på over 1 milliard kroner, jeg tror markedet sover og ikke har fått dette helt med seg✅
BioArctic: Leqembi® Iqlik™ (lecanemab-irmb) supplemental Biologics License Application regarding subcutaneous starting dose granted Priority Review by the US FDA
2026-01-26 00:30:00
Stockholm, Sweden, January 26, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting dose has been granted Priority Review by the U.S. Food and Drug Administration (FDA). Leqembi is indicated for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early Alzheimer’s disease). A Prescription Drug User Fee Act (PDUFA) action date is set for May 24, 2026. If approved, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease.
Should the FDA approve the Leqembi Iqlik 500 mg subcutaneous (SC) dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The injection time for each Leqembi Iqlik autoinjector takes approximately 15 seconds per each 250 mg injection. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall Alzheimer’s disease treatment pathway.
The sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity Alzheimer’s disease open-label extension (OLE) following the 18-month core study in individuals with early Alzheimer’s disease. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection or infusion-related reactions.
Alzheimer’s disease is a progressive, relentless disease, with amyloid beta (Aβ) and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils* (PF) that begins before amyloid plaque removal and continues afterward[1],[2],[3]. Only Leqembi fights Alzheimer’s disease in two ways - targeting both PF and amyloid plaque, which can impact tau downstream.
PUFDA 24. Mai, denne er viktig. Muligheten for å kunne administrene hjemme har ikke Eli Lilly
BioArctic: BLA for subcutaneous formulation of Leqembi® designated for Priority Review in China
2026-02-09 06:45:00
Stockholm, Sweden, February 9, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Biologics License Application (BLA) for the treatment of early Alzheimer’s disease with Leqembi (lecanemab), using a subcutaneous autoinjector (SC-AI), has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The BLA for the subcutaneous formulation was accepted for review by the NMPA in January 2026.
The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.
If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks in a hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive Leqembi treatment at home. The injection time for each autoinjector (250 mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall Alzheimer’s disease treatment care pathway.
Eisai estimates that in 2024 there were 17 million patients with Mild Cognitive Impairment (MCI) or mild dementia due to Alzheimer’s disease in China, a number that is expected to rise as the population ages.
Leqembi was launched in China in June 2024 and is available to the private market. Furthermore, Leqembi has been included in the newly introduced “Commercial Insurance Innovative Drug List” which took effect in January 2026, under new Chinese government policies that support the development of and access to innovative medicines. Based on the Commercial Insurance Innovative Drug List, commercial insurance companies will develop insurance products covering Leqembi.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for clinical development, applications for market approval and commercialization of Leqembi for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.
Gode tall i dag , ypper opp mot 2023 kurs
2 dager med litt negative nyhter på rad nå for BioArctic. Mulig neste uke blir litt bedre, er en hel del presentasjoner som Eisai skal ha på AAN om lecanemab
Heller ikke så alfor lenge til PUFDA på subq (24.mai)
BioArctic: Sales of Leqembi® totaled 26.2 billion yen in the first quarter 2026
2026-04-29 12:00:00
Stockholm, Sweden, April 29, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi for the first quarter 2026, in conjunction with their partner Biogen’s first quarter report. In total, sales of JPY 26.2 billion were recorded in the period. This results in a royalty to BioArctic amounting to SEK 161 million, which is an increase of approximately 68 percent compared to the royalty recorded by BioArctic for the first quarter 2025.
Eisai’s results for their fourth quarter and full year FY2025 (April 2025 - March 2026) will be published on May 15, 2026.
BioArctic’s report for the first quarter of 2026 will be published on May 20, 2026, at 08:00 CET.
BioArctic: Leqembi® annual sales exceed EUR 500 million - second sales milestone achieved
2026-04-29 12:00:00
Stockholm, Sweden, April 29, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has notified BioArctic that the global sales of Leqembi surpassed EUR 500 million in Eisai’s fiscal year 2025 (April 2025 - March 2026), triggering a second sales-related milestone payment of EUR 20 million to BioArctic.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for clinical development, marketing authorization applications and commercialization of Leqembi for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai, and the two companies are currently preparing for a joint commercialization in the region.
Eisai projects Leqembi® revenue to total JPY 143.5 billion for fiscal year 2026 (April 2026 - March 2027
2026-05-15 08:30:00
Stockholm, Sweden, May 15, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that Leqembi sales are expected to total JPY 143.5 billion (approximately SEK 8.4 billion) for their fiscal year (FY) 2026 (April 2026 through March 2027), corresponding to a 63 percent growth compared to the previous year. This would generate approximately SEK 880 M in royalty to BioArctic during the same period.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease. Eisai is responsible for clinical development, marketing authorization applications and commercialization of Leqembi for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai, and the two companies are currently preparing for a joint commercialization in the region.
BioArctic’s report for the first quarter 2026 will be published on May 20 at 08.00 a.m. CET.
https://www.eisai.com/ir/library/presentations/pdf/e4523_260515.pdf
Ble utsatt til 24 august
Interim Report for the period January - March 2026
2026-05-20 07:00:00
Strong financial performance with commercial milestone reached
Events during the first quarter 2026
- Leqembi® Iqlik™ (subcutaneous formulation) was granted Priority Review by the FDA in the US for initiation treatment
- Eisai submitted an expanded application for EU approval of intravenous maintenance treatment with Leqembi administered every four weeks
- The application for marketing authorization for subcutaneous initiation treatment with Leqembi was granted Priority Review in China
- New long-term and real-world data for Leqembi, presented at the AD/PD™ conference in Copenhagen, showed that patients choose to remain on treatment over a long period and that the disease-slowing treatment effect was sustained for up to four years of treatment
- Sales of Leqembi exceeded EUR 500 M during Eisai’s financial year 2025 (April 2025 - March 2026), triggering a second sales-related milestone payment of EUR 20 M
Events after the end of the period
- The Swedish NT Council announced that it currently does not recommend the introduction of Leqembi in Swedish healthcare
- The FDA has extended the review period for the supplemental Biologics License Application (sBLA) for Leqembi® Iqlik™ by three months. The application concerns subcutaneous administration of Leqembi as an initiation treatment for early Alzheimer’s disease. The new PDUFA date is August 24, 2026
- Eisai has provided a sales forecast for Leqembi of JPY 143.5 billion (approximately SEK 8.4 billion) for the company’s broken fiscal year 2026 (April 2026 to March 2027), corresponding to a growth of 63% compared with the previous year
Financial summary January - March 2026
- Net revenues amounted to SEK 437.6 M (1,289.6), of which SEK 160.8 M (96.0) related to royalty income for Leqembi and SEK 218.8 M (112.4) in a milestone payment from Eisai
- Operating profit amounted to SEK 210.8 M (1,075.3)
- Profit for the period amounted to SEK 212.4 M (1,021.5)
- Earnings per share before dilution amounted to SEK 2.40 (11.55)
- Earnings per share after dilution amounted to SEK 2.39 (11.53)
- Cash flow from operating activities amounted to SEK -166.0 M (11.8)
- Cash and cash equivalents, including short-term investments, amounted to SEK 2,034.6 M (788.6) at the end of the period
Comments from the CEO
“Each year of preserved function is of great significance for patients and their families”The first quarter of 2026 was characterized by regulatory progress and strong financial performance, driven by increasing royalty income and a milestone linked to global sales of Leqembi.
Increased sales and milestone reached for Leqembi
Global sales of Leqembi continued to increase and reached JPY 26.2 billion during the quarter, generating SEK 161 million in royalty income (+68% compared with Q1 2025) and triggering a milestone payment of EUR 20 million as sales exceeded EUR 500 million during Eisai’s financial year 2025 (April 2025 - March 2026). The royalty income and milestone payment further strengthen our already very strong financial position. This also confirms that Leqembi addresses a significant medical need and that confidence in the underlying science remains strong. At the same time, it provides us with considerable financial flexibility to continue investing long term in our research and development portfolio. The positive financial development is expected to continue. Eisai recently issued a new forecast with expected sales of JPY 143.5 billion for the fiscal year 2026 (April 2026 - March 2027), representing 63% growth year-on-year.
During the quarter, we also saw important regulatory progress globally. In January, Eisai’s supplemental application for subcutaneous initiation treatment with Leqembi Iqlik was granted Priority Review by the FDA. After the end of the quarter, the FDA extended the review period by three months, following a request for additional information. The updated PDUFA date is August 24, 2026. Similar processes are ongoing in Japan and China, where the Chinese regulatory authority has also granted Priority Review for subcutaneous administration of Leqembi.
The application for less frequent maintenance dosing with Leqembi, which was accepted for review by the European Medicines Agency during the quarter, represents an important step toward simplifying treatment following the initiation period. These regulatory milestones are crucial for making the treatment more accessible, less resource-intensive, and better adapted to both patients and healthcare systems.
Strengthened scientific and clinical evidence for Leqembi
At the international AD/PD conference in March, new long-term and real-world clinical data for Leqembi were presented. These showed that patients choose to remain on treatment over a long period and that the disease-slowing effect was sustained for up to four years of treatment. This is particularly important. Alzheimer’s disease is a progressive disease, where each year of preserved function is of great significance for patients and their families. The overall evidence base for Leqembi continues to strengthen, supported by results from clinical trials and real-world clinical practice.
At the same time, regulatory requirements, reimbursement processes, and market realities have demonstrated that introducing new treatments for Alzheimer’s disease is a complex process that varies across countries and healthcare systems. In light of this, it was with great disappointment that we learned of the decision by the Swedish NT Council not to recommend the introduction of Leqembi in Swedish healthcare at this time. As a research and innovation-driven company with roots in Swedish academia, it is painful to note that Swedish patients must wait while patients in many other parts of the world already have access to treatment. Even if the introduction of new therapies often differs between countries and systems, our position remains the same as it has always been: we do not give up. We are convinced that science, clinical experience, and continued dialogue will, over time, also provide Swedish patients with access to treatment.
Continued focus on Parkinson’s related diseases
We continue to focus on exidavnemab, where the Phase 2a study in Parkinson’s disease and Multiple System Atrophy was fully recruited in the quarter. We look forward to receiving the results later in the year and are preparing for Phase 2b. In parallel, we have taken the first steps to prepare BAN2238, an α-synuclein antibody combined with our BrainTransporter™ technology, for clinical development.
BrainTransporter opens new opportunities for growth
BioArctic has always taken a long-term perspective. In parallel with the rollout of Leqembi, we continue to build BioArctic’s future by investing in a strong and growing research portfolio within neurodegenerative diseases, including our BrainTransporter technology. We are currently expanding the platform to enable the transport of molecules other than antibodies into the brain. Behind every project is the same driving force that has brought us here - the ambition to tackle the most challenging diseases of the brain and make a real difference for patients in need. Our BrainTransporter platform enables a new way to reach the brain and has potential far beyond a single program or diagnosis. The strong interest in our research and technology confirms the strength of our strategy and is reflected in ongoing business development discussions and strategic partnerships. For me and the team working on this, these discussions are incredibly exciting and involve thorough scientific, strategic, and commercial considerations.
Overall, the first quarter demonstrates that BioArctic has entered a new phase - with a globally established medicine, a technology platform with significant potential for long term value creation, and a clear ambition to help patients with neurodegenerative diseases. In everything we do, our goal is to contribute to more patients gainining access to treatments that can make a real difference in their lives.
Gunilla Osswald
CEO, BioArctic AB
Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, May 20, at 9:30-10:30 a.m. CET. CEO Gunilla Osswald and CFO Anders Martin-Löf, together with colleagues, will present BioArctic, comment on the report and answer questions.
If you wish to participate via webcast, please use the link below. Via the webcast you are able to ask written questions.
Webcast: Q1 Report 2026
If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference: https://events.inderes.com/bioarctic/q1-report-2026/dial-in
The webcast will afterwards also be available on demand at BioArctic’s corporate website
https://www.bioarctic.com/en/investors/financial-reports-and-presentations/
Flott rapport