Biogen Inc. (NASDAQ: BIIB) may be on track to be one of the first companies with a meaningful treatment for Alzheimer’s disease (AD), and this could have huge implications for the disease and the stock.
The company announced that it completed its submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab. The completed submission followed ongoing collaboration with the FDA and includes clinical data from the Phase 3 Emerge and Engage studies, as well as the Phase 1b Prime study.
As part of the completed submission, Biogen has requested Priority Review. If approved, aducanumab would become the first therapy to reduce the clinical decline of AD and also would be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
Despite this groundbreaking work, boutique brokerage firm Wedbush reiterated its Neutral rating for Biogen with a $295 price target, which implies upside of 10% from the most recent closing price of $268.35. Wedbush detailed in its report:
For our part, the filing represents a large and complicated one and while we don’t rule out the potential for Priority Review, in the current COVID-19 environment we do wonder about resource availability. Aducanumab remains out of our formal estimates and we continue to hold a cautious outlook on the name heading into the review process.
If the FDA grants Priority Review, a PDUFA date would be set six months from the acceptance date, while Standard Review would look more like an eight-month timeline. Either way, this translates to the earliest potential commercial entry in 2021.
Biogen stock traded up over 7% to $287.77 Wednesday morning. It has a 52-week range of $215.78 to $374.99, and the consensus price target is $304.46.
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