By Colin Kellaher
Shares of Biogen Inc. surged more than 30% on Wednesday, rising after positive comments from U.S. Food and Drug Administration staff about the company's Alzheimer's disease drug candidate.
In documents posted on FDA website ahead of an advisory committee meeting on Friday, agency staff said Biogen's data on aducanumab "provides the primary evidence of effectiveness as a robust and exceptionally persuasive study demonstrating a treatment effect on a clinically meaningful endpoint and reinforced by effects on secondary endpoints, biomarkers, and in relevant subgroups."
An FDA committee of outside advisors is scheduled to meet Friday to discuss whether aducanumab is an effective treatment for Alzheimer's disease and whether to recommend approval of the drug.
The FDA is currently conducting a priority review of aducanumab, with a decision expected in early March. The agency usually follows the advice of its advisory committees, but isn't bound by the recommendations.
Biogen, a Cambridge, Mass., biopharmaceutical company, and Japan's Eisai Co. have collaborated on the global development and commercialization of aducanumab since October 2017. The companies late last year reversed course and said they would pursue regulatory approval for aducanumab after pulling the plug on studies of the drug earlier in the year.
Biogen shares were recently up 32% to $324.91, driving its market capitalization toward $50 billion.
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires
November 04, 2020 11:46 ET (16:46 GMT)Copyright (c) 2020 Dow Jones & Company, Inc.