Sage Therapeutics, Inc. (NASDAQ: SAGE) shares made a handy gain on Tuesday after the firm announced its expedited development plan for SAGE-217 following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA).
This development plan is intended to support a potential filing for approval of SAGE-217 in the U.S. for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Looking ahead, Sage plans to initiate a Phase 3 major depressive disorder (MDD) trial in the second half of 2018. Further, Sage anticipates announcing top-line data from the pivotal trial of SAGE-217 in postpartum depression (PPD) in the fourth quarter of 2018. This expedited pivotal program is supported by the results of a positive placebo-controlled trial in patients with MDD announced in December 2017.
Jeff Jonas, M.D., CEO of Sage, commented:
Sage is excited to receive feedback from the FDA that provides a possible groundbreaking path forward for the development of SAGE-217 for the treatment of depression. In this development program, we are exploring the potential for patients with MDD to feel well within days, with just a 2-week course of treatment – similar to how antibiotics are used today – instead of enduring long-term chronic treatment. We believe a medicine with rapid onset and robust response could be truly paradigm shifting. SAGE-217, if successfully developed and approved, may rewrite the textbook on how the tens of millions of people suffering from MDD are treated, ultimately turning depression into a disorder, not an identity.
Shares of Sage were last seen up about 18% at $173.11, with a consensus analyst price target of $206.79 and a 52-week range of $59.57 to $195.97.
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