Biogen, Eisai Alzheimer’s Drug Gets Full Approval (1)

July 6, 2023, 9:13 PM UTC

(Adds RBC comments, trading halt)

The FDA converted Leqembi, Eisai’s Alzheimer’s Disease drug developed with Biogen, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Biogen shares were halted postmarket.

  • The prescription “label looks relatively benign and overall favorable” and it “should facilitate” the drug’s multibillion-dollar long-term potential, RBC analyst Brian Abrahams says
    • Maintains outperform rating and $351 price target
  • Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease, FDA said

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