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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.