Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) are holding a joint meeting today (scheduled from 8:00 A.M. to 5:00 P.M. ET) to discuss Sage’s New Drug Application (NDA) currently under review for ZULRESSO™ (brexanolone) injection for the treatment of postpartum depression (PPD). The briefing materials can be found on the FDA website at: https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm598677.htm.
About Sage Therapeutics
Sage Therapeutics is a
clinical-stage biopharmaceutical company committed to developing novel
medicines to transform the lives of patients with life-altering CNS
disorders. Sage's lead product candidate, ZULRESSO™ (brexanolone)
injection, has completed Phase 3 clinical development for postpartum
depression and a New Drug Application is currently under review with the
U.S. Food and Drug Administration. Sage is developing a portfolio of
novel product candidates targeting critical CNS receptor systems,
including SAGE-217, which is in Phase 3 development in major depressive
disorder and postpartum depression. For more information, please visit www.sagerx.com.
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Contacts:
Investor Contact:
Paul Cox,
617-299-8377
paul.cox@sagerx.com
or
Media
Contact:
Maureen L. Suda, 585-355-1134
maureen.suda@sagerx.com