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SAGE Therapeutics Inc (NASDAQ:SAGE) will come into next week with things tipping in the right direction after being halted for regular trading hours action on Friday. The after-hours action suggests a rip coming with the stock indicated at nearly $147 after closing around $137 on Thursday.

That likely is all related to the news this afternoon that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes, 1 no) that data support the favorable benefit-risk profile of ZULRESSO (brexanolone) injection for the treatment of postpartum depression (PPD) when administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies (REMS) program. According to the release, the committees based their joint recommendation on the safety and efficacy data from three placebo-controlled clinical studies.

SAGE Therapeutics Inc (NASDAQ:SAGE) bills itself as a clinical-stage biopharmaceutical company, develops and commercializes novel medicines to treat central nervous system disorders.

Its lead product candidate comprises brexanolone, a proprietary intravenous formulation of allopregnanolone that has completed III clinical trials for the treatment of post-partum depression (PPD).

The company’s product pipeline also includes SAGE-217, a novel neuroactive steroid, which has completed Phase II clinical trials for the treatment of PPD, major depressive disorders, bipolar depression, Parkinson’s disease, and sleep disorders; and SAGE-718, an oxysterol-based positive allosteric modulator of NMDA receptors for the treatment of depression, Alzheimer’s disease, attention deficit hyperactivity disorder, schizophrenia, Huntington’s disease, and neuropathic pain.

In addition, its product pipeline comprises SAGE-324, a novel neuroactive steroid for the treatment of GABA hypofunction; and product pipeline that are in preclinical stage includes SAGE-689 and SAGE-105 novel GABAA receptor modulators.

Sage Therapeutics, Inc. has a strategic collaboration with Shionogi & Co., Ltd. The company was formerly known as Sterogen Biopharma, Inc. and changed its name to Sage Therapeutics, Inc. in September 2011. Sage Therapeutics, Inc. was founded in 2010 and is headquartered in Cambridge, Massachusetts.

In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($1.1B against $47.9M).

 

Fresh Start

As noted above, SAGE just announced that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes, 1 no) that data support the favorable benefit-risk profile of ZULRESSO (brexanolone) injection for the treatment of postpartum depression (PPD) when administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies (REMS) program.

This announcement has popped the stock higher, which certainly isn’t surprising. SAGE shareholders are now sitting on about 15% in gains over the past week. SAGE shares have been relatively flat over the past month of action, with very little net movement during that period.

“We are pleased the FDA Advisory Committee agreed that the benefit/risk profile of ZULRESSO supports this novel approach to treating PPD, reflecting the need for an innovative treatment option that may rapidly alleviate suffering for women with PPD and their families,” said Jeff Jonas, M.D., chief executive officer of Sage. “This is another step forward in Sage’s effort to maximize patient benefit by bringing game-changing new treatments to the market.”

SAGE Therapeutics Inc (NASDAQ:SAGE) generated sales of $90M, according to information released in the company’s most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate that has been flat on the top line.

But this news could help to push that trend back in the right direction.