1. Scrip
  2. >>Therapy Areas
  3. >>Neurological

Outlook For Biogen's Aducanumab Brightens Based On FDA Clues

 
• By Jessica Merrill

Biogen's stock soared 44% after the US FDA released briefing documents for a high-profile advisory committee meeting to review aducanumab for Alzheimer's disease.

Forest road under sunset beams
Investors have a sunnier outlook for Biogen's aducanumab • Source: Shutterstock

Biogen, Inc. is heading into a US Food and Drug Administration advisory committee meeting for aducanumab with positive momentum and even higher investor expectations after the agency released briefing documents that appear favorable. The documents were released on 4 November ahead of the meeting of the Peripheral and Central Nervous System Advisory Committee to review aducanumab, scheduled for 6 November.

Investors found reassurance in the documents that aducanumab could be on track for a rapid FDA approval as the first...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Neurological

Lilly’s Kisunla Label Update Lowers ARIA-E Risk For Alzheimer’s Patients

 
• By Mandy Jackson

The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.

J&J Seeks Schizophrenia Relapse Indication For Caplyta

 
• By Jessica Merrill

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.

France’s AB Science Plots Pivotal Masitinib Trial In Prostate Cancer

 
• By Kevin Grogan

Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By Manas Mishra

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

More from Therapy Areas

AbbVie Licenses IGI’s ISB 2001 In Second Myeloma Trispecific Deal For 2025

 
• By Alaric DeArment

IGI CEO Cyril Konto said in an interview that his company picked AbbVie for its agility, drug development acumen and expertise in areas like intellectual property and legal affairs.

Ultragenyx and Mereo Still Confident Despite Setrusumab Slip Up

 
• By Kevin Grogan

The osteogenesis imperfecta drug stumbled in a second interim analysis.

Investors Back Nuclidium’s Next-Gen Copper-Based Radiopharmaceuticals

 
• By Andrew McConaghie

The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.