Sage Therapeutics Inc. (NASDAQ: SAGE) blew out expectations early on Tuesday morning after the company released results from its mid-stage depression trial. The company announced positive top-line results from its Phase 2 clinical trial of SAGE-547 for the treatment of severe postpartum depression (PPD).

SAGE-547 achieved the primary endpoint of a significant reduction in the HAM-D score compared to a placebo. The statistically significant difference in treatment effect began at 24 hours, with an effect that was maintained at similar magnitude through to the 30-day follow-up. Remission from depression, measured at 60 hours, and was seen in seven of 10 of the SAGE-547 group compared with one of 11 in the placebo group.

The drug candidate was found to be generally well-tolerated, with no serious adverse events reported during the treatment and follow-up periods. A greater number of adverse events were reported in the placebo arm than in the treatment arm of the trial. Currently, there are no approved therapies specifically for PPD and therapeutic options in severe PPD are limited.

At this time, Sage has initiated an expansion of this Phase 2 clinical program to determine optimal dosing of SAGE-547 in PPD. This expanded trial involves dose exploration in moderate as well as severe patients, in a multicenter, placebo-controlled trial of SAGE-547 with enrollment to begin before the end of the year.

Samantha Meltzer-Brody, M.D., MPH, 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, commented on the results:

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.

Excluding Tuesday’s move, Sage has underperformed the broad markets, with the stock down about 42% year to date. Over the past 52 weeks, the stock was actually down about 54%.

Shares of Sage closed Monday down about 1% at $33.65, with a consensus analyst price target of $65.50 and a 52-week trading range of $26.28 to $77.48. Following the announcement, the stock was up over 40% at $47.30 in early trading indications on Tuesday.

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