Biogen

Eisai and Biogen announce completion of BLA submission to FDA for lecanemab-irmb (LEQEMBI) subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease, granted Fast Track designation. LEQEMBI targets highly toxic protofibrils, potentially preventing neuronal injury and cognitive decline.

S.P. reports research grants and consulting fees from various pharmaceutical companies and organizations. M.C. reports consulting fees and institutional research support from multiple entities and serves on the board of Praxis. B.H. and E.G. report no competing interests.

Eisai and Biogen complete US rolling BLA for subcutaneous Leqembi, aiming to replace IV version with once-weekly autoinjector, potentially differentiating from Eli Lilly's Kisunla and speeding up drug uptake. Lilly focuses on IV and subcutaneous forms of remternetug. FDA fast-track status for subcutaneous Leqembi but has not accepted filing yet. Eisai and Biogen also file for monthly IV maintenance dosing. Leqembi approved in US, Japan, China, South Korea, Hong Kong, Israel, UAE, and GB, but EU and Australia decisions against approval. Biogen reports $67 million in Q3 sales, with plans to expand subcutaneous injector use into induction phase by Q1 2026.

TD Cowen's Phil Nadeau maintains Buy rating on Vir Biotechnology (VIR), with shares closing at $7.49. Nadeau, with a 5.5% average return and 44.49% success rate, covers Biogen, BioMarin, and Annexon. Analyst consensus rates VIR as Moderate Buy with a $36.00 target. Vir reported $3.08M revenue and $138.38M GAAP net loss for Q2, compared to $3.8M revenue and $194.78M loss in the prior year. Vir Biotechnology focuses on treating infectious diseases using antibody, T cell, innate immunity, and siRNA technologies.

Eisai and Biogen announce completion of BLA submission to FDA for lecanemab-irmb (LEQEMBI) autoinjector for Alzheimer's disease treatment, with a potential PDUFA action date. LEQEMBI, indicated for early AD, aims to maintain effective drug concentrations and reduce protofibril-induced neuronal injury, offering a more convenient subcutaneous administration method.

Biogen shares fell 3% after Morgan Stanley downgraded the stock due to Leqembi's underwhelming launch. The firm cut revenue estimates for Leqembi by 50%, projecting $2.4 billion in sales by 2033. Challenges include reimbursement issues, delayed subcutaneous formulation, and potential competition from Eli Lilly's Kisunla. Despite early market acceleration in Japan and ongoing trials, Morgan Stanley sees limited upside for Biogen in the next 12 months.

Eisai completes rolling BLA submission to FDA for Leqembi subcutaneous autoinjector for weekly maintenance dosing in Alzheimer's disease patients.