Biogen Gains After FDA Extends Review for Alzheimer’s Drug

Biogen Inc. gained as much as 10% after the U.S. Food and Drug Administration extended the review of its experimental drug for Alzheimer’s disease, a sign its application for approval is getting careful consideration.

The FDA pushed back the decision deadline by three months to June 7, according to a statement from Biogen and its partner Eisai Co. The shares were up 9.9% at 10:25 a.m. to $294.48, the highest since Nov. 5, the day before an FDA advisory panel voted not to back the drug, called aducanumab.

Biogen originally abandoned development of the drug in 2019. The company’s shares have see-sawed since as interest in the therapy was revived after positive signs surfaced from one of two trials that initially indicated the drug didn’t work.

The company submitted a response to an information request by the FDA, including analysis and clinical data “that will require additional time for review,” according to the statement.

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