Sage Therapeutics: Breakthrough Status For Depression Drug
Zacks Investment Research | Sep 06, 2016 10:50PM ET
Sage Therapeutics, Inc. (NASDAQ:SAGE) 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).
SAGE THERAPEUTC Price
Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.