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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