Sage Therapeutics, Inc. (SAGE Quick QuoteSAGE - Free Report) announced that the FDA has granted Breakthrough Therapy designation to its experimental drug SAGE-547, which is being developed for the treatment of postpartum depression (PPD) in women. Shares gained more than 12% in yesterday’s trading session.

Postpartum depression is a severe mental disorder, found to affect women more intensely after childbirth. There are no approved therapies for this disease.

According to information provided by the company in its press release, PPD affects almost 500,000 to 750,000 mothers in the U.S. each year. The status was based on positive top-line results from a placebo-controlled phase II trial (n=21) in women with severe PPD. Data showed that SAGE-547 led to a significant, rapid and durable reduction in depression scores compared with placebo.

The trial met the primary endpoint of a significant reduction in the Hamilton Rating Scale for Depression (HAM-D) score, compared with placebo at 60 hours. The candidate was well tolerated, without having caused any death or serious adverse event. Detailed results will be presented at the 2016 International Marcé Society Biennial Scientific Conference in Melbourne, Australia, on Sep 26–28.

Breakthrough Therapy designation helps expedite the development and review of drugs that are being evaluated for the treatment of serious conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).

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Zacks Rank & Key Picks

Sage Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in medical drugs sector include Acerus Pharmaceuticals Corporation , BioSpecifics Technologies Corp. and Corcept Therapeutics Incorporated (CORT Quick QuoteCORT - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).

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