A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder/File Photo
(Reuters) – Biogen Inc is planning to file for U.S. regulatory approval for its Alzheimer’s treatment aducanumab after fresh analysis of its clinical trial showed promise, the drugmaker said on Tuesday, sending its shares up 21% before the bell.
Biogen and partner Eisai Co Ltd had in March decided to end two late-stage trials of the treatment based on a so-called “futility analysis” of data, which revealed the trials had little hope of succeeding.
Since the Alzheimer drug’s failure, Wall Street has been calling on Biogen to beef up its pipeline through deals, especially at a time when its peers are looking to sign multi-billion dollar acquisitions.
The drugmaker said on Tuesday a new analysis of the discontinued studies, which looked at a larger set of data, showed the drug was “clinically active.”
Based on discussions with the FDA, Biogen said it plans to submit a marketing application for aducanumab in early 2020.
Shares of Biogen, which have lost 25.7% of its value this year through Monday close, were up at $272.
Reporting by Manas Mishra and Trisha Roy in Bengaluru; Editing by Arun Koyyur