Sage Therapeutics (SAGE) Shares up +40 Percent After Topline Results for SAGE-547

Shares of Sage Therapeutics Inc. (SAGE) were trading up +13.60 or +40.42 percent to $47.25 per share in Tuesday’s premarket. The company announced early this morning positive top line results from a Phase 2 clinical trial of its treatment for postpartum depression, SAGE-547, achieving its primary endpoint. Sage Therapeutics stock closed at $33.65, down -0.32 or -0.94 percent in Monday’s regular trading session.

Stock Analysis

Founded in 2010 as Sterogen Biopharma Inc., Cambridge, Massachusetts based Sage Therapeutics is a clinical stage biopharmaceutical firm focusing on the development and commercialization of new medicines for the treatment of central nervous system disorders.

Sage’s lead product candidate consists of SAGE-547, a proprietary intravenous formulation of allopregnanolone which is being developed as an adjunctive therapy for treating super-refractory status epilepticus (SRSE) in addition to treating severe post partum depression. The company’s pipeline also includes SAGE-217, a novel neuroactive steroid for the treatment of orphan epilepsies and essential tremor; and SAGE-689, an adjunctive IV therapy where antiseizure and sedation is preferable before the introduction of general anesthesia.

This morning, the company announced positive top line results from a Phase 2 clinical trial of SAGE-547, achieving its primary endpoint of a significant reduction of the HAM-D score compared to a placebo at 60 hours (p=0.008). The results represent a 20 point mean reduction in depression scores of the group taking SAGE-547 at the primary endpoint of 60 hours through the end of the trial with a greater than 12 point difference from the placebo group.

The significant difference in the treatment began at 24 hours, (p=0.006) maintaining an effect with a similar magnitude through to the 30 day follow up (p=0.01) Remission from depression was noted at 60 hours and seen in 7 of 10 of the SAGE-547 group compared to 1 of 11 in the placebo group.

Jeff Jonas, M.D., Chief Executive Officer of Sage said in the company’s press release that, “These data speak for themselves. The unmet need in the PPD patient population cannot be overstated. Given the societal impact of this condition, and the possible identification of a biological basis for treating these women, we are hopeful these data will point to a new understanding of this disorder and the development of effective therapies.”

Samantha Meltzer-Brody, M.D., M.P.H., Associate Professor and Director of the UNC Perinatal Psychiatry Program of the UNC Center for Women's Mood Disorders and primary investigator for the PPD-202 Trial stated that, “This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date. The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date. The data show the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”

The SAGE-547 treatment was well tolerated by the group with no serious adverse effects reported during the treatment and follow-up periods. More adverse effects were reported from the placebo group in the treatment segment of the trial. There are currently no approved therapies specifically treating postpartum depression with limited options for therapy in cases of severe postpartum depression.

Other News About SAGE

Sage Reports Positive Top-line Results from Phase 1 Clinical Program of SAGE-217

The orally active compound is intended to enhance GABA receptor mediated inhibition in the brain.

Bulls see upside in Sage Therapeutics

Last month, 2,200 SAGE July 35 calls were purchased at a price of $1.25-$1.50.
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Published on Jul 12, 2016
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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