United States — Food and Drug Administration & Biogen

United States — Food and Drug Administration: The United States — Food and Drug Administration has cleared the CareMiBrain system for use and has approved new monoclonal antibody treatments for Alzheimer's Disease, creating a market for the PET scans.

Biogen: Biogen, in collaboration with Eisai, developed Leqembi, one of the FDA-approved monoclonal antibody treatments for Alzheimer's Disease, which requires a positive beta-amyloid brain scan.

Biogen: Biogen is a funding partner for the project, supporting the research into Alzheimer s disease biomarkers.

Biogen: Biogen entered into a joint development and commercialization agreement for lecanemab with Eisai in 2014 and is involved in the AHEAD 3-45 clinical study.

Biogen: Biogen announced compelling topline results from its Phase 2 CELIA study for diranersen, showing robust biomarker impact and cognitive benefit in early Alzheimer's disease, despite not meeting the primary endpoint for dose response. This positive data gives Biogen confidence to advance diranersen to registrational development.