Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

An About Face As Biogen Says It Will File Aducanumab In Alzheimer’s

Executive Summary

Biogen surprised investors with news that it will file aducanumab with the FDA based on data from more patients treated at the highest dose than in the interim futility analysis that led to termination of two Phase III studies in March.

You may also be interested in...



Aducanumab Approval Decision Delayed: Could This Be Good News?

Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.

Biogen’s Aducanumab: One Positive Phase III Trial Is Good Enough For Demonstrating Efficacy, US FDA Says

Negative results from the Phase III ENGAGE trial – which may have been influenced by imbalance in ‘rapid progressors’ and differential effects of dosing protocol changes – do not negate persuasiveness of positive results from the EMERGE study, agency says in advisory committee briefing document; statistical reviewers dissent, call for a new trial of the Alzheimer's drug.

Outlook For Biogen's Aducanumab Brightens Based On FDA Clues

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM007836

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel