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Sage Therapeutics' Depression Drug Fails in Study, Stock Down

Zacks Equity Research

Shares of Sage Therapeutics Inc. SAGE plunged 59.7% after the biopharmaceutical company stated that a phase III study on SAGE-217 for the treatment of major depressive disorder (MDD) failed to meet the primary endpoint. The MOUNTAIN study evaluated the efficacy, safety and pharmacokinetics of SAGE-217 in adult patients diagnosed with MDD.

The phase III study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. SAGE-217 30 mg, given once-daily as an oral treatment, was associated with a mean reduction of 12.6 in HAM-D total score compared to 11.2 for placebo.

Patients in the SAGE-217 30 mg group achieved statistically significant reductions in the HAM-D total score at Days 3, 8 and 12. The SAGE-217 development program includes five other pivotal studies, two of which have reported positive data, one in MDD and another in postpartum depression (PPD), and three are ongoing.

SAGE-217 works by targeting receptors of a neurotransmitter known as GABA, helping restore the normal balance in the brain.

We note that last month another company, VistaGen Therapeutics VTGN, announced disappointing results from a mid-stage study, ELEVATE, on pipeline candidate, AV-101. The candidate is an NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, which is being evaluated as an adjunctive treatment of MDD.

The data showed that the AV-101 treatment arm did not differentiate from placebo on the primary endpoint (change in the Montgomery-Åsberg Depression Rating Scale [MADRS-10] total score compared to baseline).

Earlier this year, Alkermes ALKS received a Complete Response Letter from the FDA regarding its new drug application for ALKS 5461 for the adjunctive treatment of MDD. 

 

Sage Therapeutics, Inc. Price

 

Sage Therapeutics, Inc. Price

Sage Therapeutics, Inc. price | Sage Therapeutics, Inc. Quote

Zacks Rank & A Stock to Consider

SAGE currently has a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Anika Therapeutics Inc. ANIK, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.

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Anika Therapeutics Inc. (ANIK) : Free Stock Analysis Report
 
Alkermes plc (ALKS) : Free Stock Analysis Report
 
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