Sage Therapeutics Stock Up On SAGE-547 Regulatory Update

Shares of Sage Therapeutics, Inc. (NASDAQ:SAGE) gained 7.5% after the company announced its expedited development plan for SAGE-547 following the receipt of formal meeting minutes from a breakthrough therapy meeting with the FDA.

A look at the company’s year-to-day share price movement shows that the stock has outperformed the Zacks classified Medical Drug industry. The stock’s price declined 4.5% in the year-to-date period, which compared favorably to the 25.2% decline for the industry.

Coming back to the latest news, the program is intended to support a potential filing (anticipated in 2018) for SAGE-547 for the treatment of postpartum depression (PPD).

Note that Sage Therapeutics initiated an expansion of the phase III clinical program on SAGE-547, following positive top-line results from a phase II 202A study. The study will evaluate dose ranges of the candidate in severe PPD patients and evaluate its efficacy in patients with moderate PPD.

The company reported that it will modify the phase III study, including an increase in sample size, to facilitate global registration. Top-line data are anticipated in the second half 2017.

We remind investors that in Sep 2016, SAGE-547 was granted Breakthrough Therapy Designation in the U.S. for PPD. Moreover, in November, the candidate received PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).

PPD, an affective disorder impacting women after childbirth, is estimated to occur in 500,000 to 750,000 mothers in the U.S. each year.

Meanwhile, Sage Therapeutics is studying SAGE-547 for other indications as well. The company is currently enrolling patients in a phase III study – STATUS – to evaluate the safety and efficacy of SAGE-547 for the treatment of patients with super-refractory status epilepticus.

SAGE THERAPEUTC Price and Consensus

Zacks Rank & Key Picks

Sage Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) , Cambrex Corporation (NYSE:CBM) and Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) . Each stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%.

Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%.

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