By a vote of one for, eight against, and two abstaining, the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee concluded Friday that positive clinical data from Biogen’s (BIIB) “EMERGE” trial, when “viewed independently and without regard for” data from the company’s “ENGAGE” trial, were not sufficient to convince it that aducanumab is an effective treatment for Alzheimer’s.
The Advisory Committee furthermore voted zero to seven (with four abstentions) against a finding that Biogen’s PRIME study data was any better. And although on the bright side, the committee voted five-to-zero-to-six sort of in favor of the verdict that Biogen has “presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology,” in the end, they concluded by a crushing zero-to-10 margin (with one abstention) that it was not reasonable to rely upon the EMERGE data as a reason to approve the drug for commercial sale.
That’s the bad news.
The good news is that the Advisory Committee’s recommendations above are not binding on the FDA itself, and the FDA could, therefore, end up approving the drug anyway. (The FDA intends to render its own final verdict by March 7, 2021).
But the other bad news is that, when you get right down to it, the Advisory Committee’s conclusions were “overwhelmingly negative,” as J.P. Morgan analyst Cory Kasimov opined in a note out today. Tallying up the results, points out Kasimov, Biogen garnered a grand total of just “one yet vote across the three key efficacy questions.” And this, in the analyst’s opinion, “certainly calls into serious question the FDA’s very positive stance on aducanumab.”
Calling the Advisory Committee’s verdicts a “near unanimous vote against aducanumab and strong commentary against the FDA’s own analyses,” Kasimov warns that “with the FDA’s reputation already in a precarious position, it could be difficult — maybe impossible — to go against an expert panel at this time no matter how badly they want this.”
Which kind of makes the March 7 decision sound like a foregone conclusion, and not one that favors Biogen.
So what does this mean for Biogen and the investors who’ve placed their faith in it? On the one hand, the aducanumab polls were unqualifiedly bad for Biogen. Still, they apparently weren’t quite bad enough to shake JP Morgan’s faith in the company so as to necessitate downgrading the stock from “neutral” (the stock’s current rating) to “sell.” Nor did Kasimov cut his price target on the stock from its present level of $269 per share.
That being said, when you consider that Biogen stock costs nearly $329 a share today, Kasimov’s $269 price target does still imply that Biogen stock is worth nearly 19% less than what investors are currently paying for it. (To watch Kasimov’s track record, click here)
This stock has attracted plenty of interest from Wall Street’s analysts. BIIB’s analyst consensus rating is a Moderate Buy based on 27 reviews, which include 11 Buys against 14 Holds and 2 Sells. (See BIIB stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.