Shares in Biogen leaped 10% on Friday after the company said that the U.S. Food and Drug Administration (FDA) granted aducanumab, its investigational treatment for Alzheimer’s disease, priority review.
The stock jumped to $305.71 as Biogen (BIIB) and Japan’s Eisai announced that the FDA accepted their Biologics License Application (BLA) for aducanumab. The priority review speeds up the FDA review with an action date for a decision set for March 7. The FDA stated that, if possible, it plans to act early on this application under an expedited review.
If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes. Aducanumab is a human monoclonal antibody designed to treat early Alzheimer’s disease.
“The FDA’s acceptance of the aducanumab BLA with priority review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Biogen CEO Michel Vounatsos. “We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.”
Biogen said the FDA had decided to speed up the review without the company even having to use its priority review voucher for the aducanumab BLA. The FDA also stated that it is currently planning to hold an advisory committee meeting for this application on a yet-to-be-determined date.
J. P. Morgan analyst Cory Kasimov maintained a Hold rating on the stock with a $279 price target, saying that the FDA move is potentially a favorable signal, but nevertheless he believe that the planned advisory committee is still likely the “key gating factor”. (See BIIB stock analysis on TipRanks)
“Overall, with clear visibility on timelines for a regulatory decision, we think that this acceptance is likely to finally kick off a fear of missing out (FOMO) trade (which we feel like we’ve been talking about for years)...at least until we get closer to the advisory committee,” Kasimov wrote in a note to investors. “At this point we still consider the ultimate fate of aducanumab to more or less be a coin toss."
Meanwhile, the rest of the Street is cautiously optimistic on the stock. The Moderate Buy analyst consensus shows 10 Buys versus 15 Holds and 3 Sells. With shares up 3% so far this year, the $316.82 average price target implies a modest 3.6% upside potential to current levels.
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