United States — Food and Drug Administration & Biogen

United States — Food and Drug Administration: Approved Leqembi Iqlik on July 13, enabling the US launch.

Biogen: Joint development and commercialization partner for lecanemab; benefits from increased sales.

United States — Food and Drug Administration: FDA approval would be required for diranersen to reach the market, following potential Phase III success.

Biogen: Biogen's diranersen showed promising Phase II results, slowing cognitive decline by 26% in early Alzheimer's. The company plans a Phase III trial, positioning it as a leader in tau-targeting therapies.

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.

United States — Food and Drug Administration: The FDA approved Palsonify in 2025, enabling its commercial availability. The agency's regulatory decisions are relevant to the value of the acquired assets.

Biogen: Mentioned as comparison for premium paid in acquisitions.

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.

Biogen: Biogen is a joint development and commercialization partner for Lecanemab, participating in clinical studies. While not the primary focus of this sales forecast, it benefits from the drug's success.