Biogen Inc. (NASDAQ: BIIB) shares rocketed up on Wednesday after briefing documents from the U.S. Food and Drug Administration (FDA) provided evidence of the effectiveness of the firm’s Alzheimer’s disease treatment.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet virtually this coming Friday to review Biogen’s marketing application for aducanumab. So far the documents that have been released paint the picture of a potential approval.
The FDA thinks that results from one of the two Phase 3 trials, Study 302, are “highly persuasive” and the study is “capable of providing the primary contribution to a demonstration of substantial evidence of effectiveness of aducanumab.”
In response, Wedbush reiterated a Neutral rating with a $244 price target, implying downside of 1% from the most recent closing price of $247.01.
Wedbush detailed in a quick hit:
No change to outlook on BIIB. The release of FDA Advisory Committee documents highlights several themes likely to emerge at the upcoming panel review (11/6/2020). The documents include four voting questions (eight questions total). Bottom line – FDA’s briefing book totals >300 pages and multiple prerecorded videos, and we continue to digest the material. However, our first reaction is that the agency appears largely aligned with Biogen on key areas. While we continue to expect a vigorous debate at the panel, we think the new base case should be a potential approval.
Excluding Wednesday’s move, Biogen stock had underperformed the broad markets with a pullback of about 17% year to date. In the past 52 weeks, the share price was down closer to 16%.
Biogen stock traded up 44% to $355.28 on Wednesday, in a 52-week range of $243.25 to $374.99. The consensus price target is $287.38.