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From Early 2020 To Q3: Biogen Shifts Aducanumab Filing Expectations Again

 
• By Mandy Jackson

The company remains confident in US FDA approval for the first disease-modifying Alzheimer’s drug based on current data, but Biogen needs more time to complete the BLA filing.

Mobile Electronic Traffic Sign stating “expect Delays” taken at sunset with traffic blurred driving past the sign and traffic cones
Biogen will file its aducanumab BLA in Q3 versus prior guidance of early 2020 • Source: Shutterstock

Biogen still believes that aducanumab can win US Food and Drug Administration approval as the first disease-modifying treatment for Alzheimer’s disease, but external confidence in the company’s ability to achieve that goal in a timely manner was shaken on 22 April. That's when Biogen revealed in its first quarter earnings report that it does not expect to complete the biologic license application (BLA) for aducanumab until the third quarter of this year.

The company has said since October that it would file the BLA in early 2020, although Biogen’s guidance in January...

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Japan Results Roundup: Reduced Forex Impact, Uncertain US Tariff Outlook

 
• By Lisa Takagi

Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.

S&E In Brief: Launch Updates And Political Headwinds

 
• By Sushmita Panda

Madrigal and Syndax update investors on their key launches, while Merck KGaA weighs in on the possibility of direct-to-consumer sales in the US.

Lupin Confident Of US Growth On Tariff Mitigation, Rides High On Tolvaptan

 
• By Vibha Ravi

Lupin is hoping moves like intellectual property transfer for some products to the US will help mitigate the tariff impact even as it counts on growth from planned launches of GLP-1s and biosimilars while riding high on tolvaptan launched in Q1.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

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