Biogen's completed Biologics License Application submission for aducanumab "finally begins the big journey of what will be a hotly debated FDA review," Jefferies analyst Michael Yee tells investors in a research note.
The analyst assumes Biogen will get a Priority Review based on the unmet need in Alzheimer's disease. An FDA action date would be assigned thereafter and if Priority, a PDUFA would fall around March 8, 2021, Yee tells investors in a research note. The analyst values Biogen shares at $175 to $225 with no Tecfidera patent and no aducanumab. However, Yee assigns a 55% probability of aducanumab gaining approval.
This "best case" could yield a share price above $500, adds the analyst. However, Tecfidera generic risk now in 2021 along with an aducanumab decision "could be a double whammy," Yee cautions.
He keeps a Hold rating on Biogen with a $320 price target. The stock in premarket trading is up 8% to $288.98.
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