Biogen Seeks FDA Approval for Expanded Alzheimer's Drug Label

Biogen and Eisai have submitted a marketing application to the FDA for an expanded label of Alzheimer's drug Leqembi, allowing it to be administered as a weekly subcutaneous autoinjector. Analysts predict a 20.67% upside for Biogen shares with target prices ranging from $118.00 to $260.00, while GF Value estimation suggests a 54.46% upside from the current stock price. The application benefits from Fast Track status, potentially accelerating approval.

Biogen Inc. and Eisai Co., Ltd. have submitted a marketing application to the U.S. Food and Drug Administration (FDA) for an expanded label of their Alzheimer's drug Leqembi. The application seeks to allow Leqembi to be administered as a weekly subcutaneous autoinjector, a development that could significantly enhance patient convenience and compliance. The application benefits from Fast Track status, potentially expediting the approval process [1].

The expanded label application is based on the evaluation of subcutaneous (SC) lecanemab administration across various doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension (OLE). If approved, the autoinjector could be used to administer a once-weekly starting dose, providing an alternative to bi-weekly intravenous (IV) dosing. This development would expand treatment options for patients and their caregivers, allowing for home administration and reducing healthcare resource requirements [1].

Leqembi, which is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia, is currently approved in 48 countries and under regulatory review in 10 others. The drug targets both amyloid plaques and protofibrils, which contribute to the neurotoxic processes associated with AD. The recent FDA approval of the subcutaneous formulation LEQEMBI IQLIK marks a significant advancement in the treatment of early-stage Alzheimer’s disease, enabling at-home maintenance dosing after an initial 18-month IV treatment course [2].

Analysts predict a 20.67% upside for Biogen shares, with target prices ranging from $118.00 to $260.00. GF Value estimation suggests a 54.46% upside from the current stock price. These projections reflect the potential market growth and increased accessibility of Leqembi, which is priced at $19,500 per year. The drug's approval is expected to drive market growth to $12.07 billion by 2034, with Eisai and Biogen co-commercializing and co-promoting the product [2].

The approval of LEQEMBI IQLIK signals a broader shift in biopharma, combining precision drug delivery, robust clinical outcomes, and scalable commercial models. This innovation is part of a broader wave of innovation in neurodegenerative therapies, with the Alzheimer’s drug pipeline now including 138 candidates in 182 clinical trials. The market's projected 8.7% CAGR through 2034 is attracting capital from both established players and startups [2].

However, risks persist. High drug prices raise concerns about payer reimbursement and patient access. Additionally, the long-term safety profiles of anti-amyloid therapies remain under scrutiny, with ARIA monitoring protocols adding operational complexity [2]. Investors must navigate a crowded pipeline, where Eli Lilly’s donanemab and Roche’s gantenerumab compete for market share.

The road ahead is promising for biopharma growth, with innovations in delivery systems and biomarker-driven trials redefining neurodegenerative care. The approval of LEQEMBI IQLIK is a catalyst for systemic change, encouraging investment in early-stage innovations and data-driven approaches in healthcare [2].

References:
[1] https://www.tradingview.com/news/reuters.com,2025-09-03:newsml_JCN102349a:0-eisai-initiated-rolling-supplemental-biologics-license-application-to-the-u-s-fda-for-leqembi-r-iqlik-tm-lecanemab-irmb-as-a-subcutaneous-starting-dose-for-the-treatment-of-early-alzheimer-s-disease-under-fast-track-status/
[2] https://www.ainvest.com/news/fda-approval-leqembi-iqlik-game-changer-early-alzheimer-treatment-catalyst-biopharma-growth-2508/