Biogen
to seek U.S. approval for Alzheimer's drug; shares jump 21%
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[October 22, 2019]
(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.
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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."
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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)
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