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Investing.com -- BioArctic AB shares rose more than 3% on Monday after the U.S. Food and Drug Administration approved a subcutaneous version of Alzheimer’s drug Leqembi for maintenance treatment.
The FDA cleared the 360mg weekly injection, called Leqembi IQLIK, to be used after 18 months of initial treatment with intravenous doses of 10mg/kg every two weeks. The new option provides an alternative to monthly IV infusions.
The launch in the United States is scheduled for Oct. 6. Data had previously shown that the subcutaneous maintenance treatment was equivalent to intravenous dosing.
RBC Capital Markets in a note said that while the maintenance approval itself may not directly increase Leqembi’s uptake, it could help relieve capacity constraints at infusion centers.
The analysts added that the decision also reduces regulatory risk for subcutaneous dosing at initiation, with a filing expected soon and potential FDA approval anticipated in the first half of 2026.