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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 was less specific when executives indicated the filing would take place as soon as possible

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Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

 
• By Mandy Jackson

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.

BeiGene To Trade Beach For Chalet In Swiss Redomiciling As BeOne

 
• By Alaric DeArment

The biotech saw a slight quarter-over-quarter decline in sales from the BTK inhibitor Brukinsa, which it attributed to seasonality, while revenues overall missed some analyst estimates.

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Shionogi In $1bn Deal For Japan Tobacco’s Pharma Ops

 
• By Ian Haydock

Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.

Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

 
• By Mandy Jackson

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.