By Colin Kellaher

Shares of Sage Therapeutics tumbled more than 45% in premarket trading Monday after the U.S. Food and Drug Administration rejected a key use for the biopharmaceutical company's depression drug with partner Biogen.

Sage and Biogen were seeking FDA approval of Zurzuvae, a fast-acting depression drug, for major depressive disorder, or MDD, and postpartum depression.

The agency late Friday gave a green light to Zurzuvae in postpartum depression but declined to approve the drug in the much larger indication of MDD, saying more studies were needed.

Biogen and Sage, both based in Cambridge, Mass., late Friday said they were reviewing their next steps for Zurzuvae in MDD, and Sage on Monday said it is evaluating steps to extend its cash runway, including a pipeline prioritization and a workforce reorganization.

Sage shares, which closed Friday at $36.10, were recently down nearly 47% to $19.24 in premarket trading, while shares of Biogen slipped 3% to $261.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 07, 2023 08:03 ET (12:03 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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