Biogen's accelerated PDUFA lecanemab approval the likely outcome claim analysts

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By Sam Boughedda

Biogen's (NASDAQ:BIIB) lecanemab's accelerated approval PDUFA is slated for Friday, January 6, and analysts have been weighing in with their view heading into the date.

Jefferies analysts, who have a Buy rating and a $350 price target on Biogen shares, said in a note to clients that the "consensus assumes clean approval, which is reasonable though mostly expected."

"There is always some typical small chance of some administrative delay or timeline slip due to submission of Phase III data, which would not be a big deal and or other things unexpected, but generally we assume approval, good label, and really need CMS reimbursement ASAP to get sales visibility going," they explained.

Meanwhile, Wells Fargo analysts, who have an Overweight rating and a $350 per share price target on Biogen, told investors that while the approval has previously been considered an easy one, they suspect some doubts may have emerged, especially after the Congressional report raised questions about the Aduhelm approval process. They added that there are slight worries it could make the FDA cautious.

"This may have been the reason for the stock being weak last month (-8% vs. NBI down 3%). We think lecanemab is a different story, as we now have successful Ph3 data published in a reputed journal NEJM. This should still make approval likely, but given these doubts, we think approval could potentially move the stock up 5-10%," writes the analysts.

"Denial due to insufficient data could potentially move the stock down by 5-7%, but the stock could recover, since we already have successful Ph3 data. Approval still seems the more likely scenario, in our view."