Commenting on FDA’s Summary Review of Leqembi, or lecanemab, that is now available, RBC Capital analyst Brian Abrahams says that overall, given that the benefit/risk assessment appeared to already consider the reported Phase III results, as well as recently reported open-label extension deaths, he sees a very high likelihood the drug will ultimately receive full approval in the second half of 2023 without any major labeling changes, barring any substantial emerging safety issues. Additionally, the clearly persistent amenability to plaque reductions as a surrogate should facilitate a path for their subQ form – critical for optimizing long-term revenue potential – though may also open the door for competitors, Abrahams argues. He continues to be a buyer of Biogen on an underappreciated long-term Alzheimer’s opportunity and likely pipeline reboot under new management. The analyst has an Outperform rating on the shares with a price target of $362.
Published first on TheFly
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