SAGE Therapeutics (NASDAQ: SAGE) reported Q2 EPS of ($0.36), versus ($1.89) reported last year.

Conditional acceptance granted by U.S. Food and Drug Administration (FDA) for the proprietary name ZULRESSO™ for Sage’s intravenous formulation of brexanolone

Continuing to execute commercial build and launch readiness for ZULRESSO™ (brexanolone injection) in postpartum depression ahead of PDUFA target date of December 19, 2018

Accelerating breakthrough pivotal program for SAGE-217 in depression with key trial milestones expected in 4Q 2018

Progressed clinical pipeline with SAGE-718 Phase 1 multiple ascending dose and SAGE-324 Phase 1 single ascending dose trial initiations and planned SAGE-217 Phase 2 trial initiation in bipolar depression

Conference call today at 8:00 AM ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Sage Therapeutics, Inc. (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today reported business highlights and financial results for the second quarter ended June 30, 2018.

“This quarter we continued to make great progress on our journey to become a multinational biotech company,” said Jeff Jonas, M.D., chief executive officer of Sage. “This was underscored by the regulatory milestones and commercial launch readiness activities in support of ZULRESSO™ (brexanolone injection), the initiation of our strategic collaboration with Shionogi on the development and commercialization of SAGE-217 in key Asian markets, and the ongoing advancement of our early stage drug candidates, SAGE-718 and SAGE-324, into new Phase 1 clinical studies. With the upcoming potential approval and launch of ZULRESSO, we remain focused in our approach to forge news paths for the treatments of CNS disorders.”

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