Biogen, Sage win FDA priority review for depression therapy
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Biogen (NASDAQ:BIIB) and Sage Therapeutics (NASDAQ:SAGE) announced Monday that the FDA accepted their New Drug Application (NDA) for oral depression therapy zuranolone under the agencyâs priority review. Sage (SAGE) shares have added ~5%, while Biogen (BIIB) is trading flat in reaction.

The FDA has granted August 05, 2023, as the action date for the NDA, which is intended for the U.S. approval of zuranolone for major depressive disorder (MDD) and postpartum depression (PPD).
The NDA is backed by data from LANDSCAPE and NEST clinical programs and data from a Phase 2 trial, partner Shionogi (OTCPK:SGIOF) (OTCPK:SGIOY), conducted in Japan for zuranolone in adults with MDD, the companies said.
âThe FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression,â noted Priya Singhal, Biogenâs (BIIB) head of development and interim head of research.

Seeking Alpha contributor, Clinically Sound Investor issued a Hold rating on Sage (SAGE) in December, arguing âthat zuranolone could struggle with approval.â