Biogen shares fell 1.2% in early trading.
A Japanese health ministry panel said on Wednesday that inconsistent trial results made it difficult to determine the efficacy of an Alzheimer's treatment developed by Eisai Co and Biogen Inc.
Tokyo-based Eisai and its United States partner filed for Japanese regulatory approval just over a year ago for the drug Aduhelm, which was approved in the United States in June.
In a statement the panel cited inconsistent results from global Phase III trials and a lack of clinical significance in the drug's ability to reduce plaques in the brain. The panel said it would take another look if further data is submitted.
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