Biogen Expects Confirmatory Aduhelm Data In 2026, But Is It Too Late?
Data on rivals will be available well before
Biogen's update on the timeline for running a confirmatory study of the Alzheimer's treatment is faster than the nine years required by FDA under the accelerated approval.
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Without An Alzheimer’s Blockbuster, Biogen Is A Ship Without A Growth Rudder
In addition to its uncertain attempt at near-term revenue growth with Eisai-partnered lecanemab, Biogen recently ended multiple R&D programs and will pay $900m to settle a whistleblower lawsuit.
Eisai/Biogen Maintain Lead Over Lilly In New Race To Alzheimer’s Approval
The US FDA accepted an application for accelerated approval and set a 6 January action date, giving lecanemab ample time to reach the market ahead of Lilly’s competing anti-amyloid antibody donanemab.
Eisai’s Lecanemab BLA Filing A Key Step For Ailing Biogen
Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab.