October 22, 2019 / 10:43 AM / a month ago

Biogen to seek U.S. approval for Alzheimer's drug; shares jump 16%

Oct 22 (Reuters) - Drugmaker Biogen Inc said on Tuesday it was planning to file for U.S. regulatory approval for its Alzheimer’s treatment aducanumab after fresh analysis of its clinical trial showed promise.

Biogen and partner Eisai Co Ltd had decided in March to end two late-stage trials of aducanumab based on a so-called “futility analysis” of data, which revealed the trials had little hope of succeeding.

Based on discussions with the FDA, Biogen said it plans to submit a marketing application for aducanumab in early 2020.

Biogen shares jumped 16% in trading before the opening bell. (Reporting by Manas Mishra and Trisha Roy in Bengaluru; Editing by Arun Koyyur)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below