Andrzej Rostek Biogen ( NASDAQ: BIIB ) has received EU regulatory approval for its drug Qalsody, also known as tofersen, for the treatment of ALS associated with a mutation in the superoxide dismutase 1 gene, or SOD1-ALS. The product was granted marketing authorization under exceptional circumstances due to the rarity of the disease, which is a genetic form of the illness. It also has EU orphan drug status.
Qalsody was discovered by Ionis Pharmaceuticals ( IONS ) and later licensed to Biogen under a collaborative development agreement. The drug received accelerated approval from the FDA in 2023. More on Biogen Biogen: Reasons To Be Cheerful After Upbeat Q1 Earnings Biogen: Don't Overthink This One Biogen's Revenue Dip Meets Cost Cuts In Q1 (Rating Upgrade) Biogen inks $1.
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