Biogen Stock (NASDAQ:BIIB)
The expedited approval PDUFA for lecanemab, which is manufactured by Biogen (NASDAQ:BIIB), is scheduled to take place on Friday, January 6, and analysts have been giving their opinions in the lead-up to the day.
The analysts at Jefferies, who has a Buy rating on Biogen stock and a price objective of $350 for the stock, said in a letter to clients that the “consensus expects clean clearance,” which is real even though it is generally anticipated.
In general, we presume clearance and a solid label, and we need CMS reimbursement as soon as possible to get sales visibility. Still, there is always an average tiny probability of some administrative delay or schedule slide owing to the submission of Phase III data, which would not be a significant problem, and possibly other unforeseen things, they stated.
In the meantime, analysts at Wells Fargo, who have an Overweight rating and a price target of $350 per share on Biogen, told investors that while the approval was previously thought to be a simple process, they now suspect that some doubts may have emerged, particularly after the Congressional report raised questions about the approval process for Aduhelm. The analysts have a price target of $350 per Biogen stock. They also said there are some concerns that it would cause the FDA to be cautious.
“It’s possible that this was the cause of the stock’s poor performance last month (-8%, compared to NBI’s -3% loss). Because we now have successful Ph3 data published in the highly regarded publication NEJM, we believe that lecanemab is a different story altogether. This should still make approval probable, but given these reservations, we believe approval may boost the stock up anywhere from 5 to 10%, “the analysts have said.
“If the application is denied because there is insufficient data, the stock price might drop by 5–7%; however, the price could rebound given that we already have successful Ph3 data. In our opinion, approval remains the scenario that is most likely to occur.”
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Author Shariq Khan 
