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Sage shares rise after postpartum depression drug meets main goal

(Reuters) - Sage Therapeutics on Thursday said its drug to treat moderate and severe postpartum depression succeeded in reducing symptoms in patients enrolled in two late-stage trials, sending its shares up 50 percent in pre-market trade.

Sage said it plans to submit an application for marketing approval of the injectable drug, brexanolone, to the U.S. Food and Drug Administration in 2018.

Shares of the Cambridge Massachusetts-based company rose to $94 in pre-market trading, positioning the stock to open at an all-time high. The stock closed at $62.66 on Wednesday.

Postpartum depression, a more severe form of “baby blues”, is a common complication of childbirth that affects 1 in 9 women, according to the Centers for Disease Control and Prevention.

The company said brexanolone met the main goal of both trials, as women treated with the drug had less severe symptoms of depression, compared with those given a placebo.

Patients were assessed by a scale that rated the severity of their depression symptoms such as mood, feelings of guilt, suicide thoughts and insomnia.

An intravenous brexanolone drug could hit peak sales of $400 million in 2026, according to Edward Nash, an analyst at SunTrust Robinson Humphrey.

The success of Sage’s follow-on program, which is testing an oral version of the drug, could generate another $668 million, making it “a potential blockbuster”, Nash added.

There are currently no FDA-approved therapies for postpartum depression, which affects about 10 percent to 20 percent of women giving birth in the United States, the company said.

Earlier this year, brexanolone failed a late-stage trial testing it as a treatment for a life-threatening seizure disorder.


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