Biogen shares jump 9% after FDA extends review period for Alzheimer’s treatment


Biogen Inc. shares
rose 9% Friday, after the company said the U.S. Food and Drug Administration has extended the review period for its investigational Alzheimer’s disease treatment aducanumab by three months. As part of the review, Biogen submitted a response to an information request from the regulator and provided it with additional data and analyses, “which the FDA considered a Major Amendment to the application that will require additional time for review,” Biogen said in a statement. . Leerink analysts said the news is a positive as such a move usually means the FDA wants to approve the drug. “Recall, in our preview note last October, we believed that Biogen’s data package in totality was supportive of approval, and we are even more confident in that outlook now,” analysts led by Marc Goodman wrote in a note to clients. Biogen shares have gained 19% in the year to date, while the SPDR S&P Biotech ETF
has gained 41% and the S&P 500
has gained 16%.


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