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

Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By Joseph Haas

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Skyhawk Looks To Soar With Huntington’s Hope

 
• By Kevin Grogan

Oral RNA splicing modulator has gone into a Phase II/III trial

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

More from Therapy Areas

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By Aakash Babu

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

GSK, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

 
• By Vibha Ravi

GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut

Pfizer’s Hympavzi Poised For Broader Hemophilia Label

 
• By Alaric DeArment

The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.