Biogen gains on “super clean” FDA docs on Alzheimer’s drug ahead of AdCom vote
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The FDA issued what Mizuho described as "super clean" briefing documents on Leqembi, the Alzheimer's therapy developed by Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) (OTCPK:ESAIY), sending the shares of the U.S. biotech higher Wednesday ahead of an AdCom meeting later this week.
The agency granted accelerated approval for the anti-amyloid agent in early April, issuing a priority review with a July 06 target action date in March for the companies' marketing application to seek full approval.
Ahead of the decision, the FDA's advisory committee on nervous system drugs is set to meet on June 09 to discuss its approvability, and the regulator's briefing documents on Wednesday precede their meeting. 

The documents containing only 35 pages and one voting question, show a "much simpler story," Mizuho analyst Salim Syed wrote, with a Buy rating and $340 per share target on Biogen (BIIB).
Syed argued that FDA documents on the companies' controversially approved Alzheimer's drug Aduhelm ran into over 100 pages and consisted of four voting questions.
"The briefing docs read super clean -- don't really see any surprises here at all," the analyst opined, adding that despite being a bit longer, even the safety summary did not flag any new concerns.
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