Shares of Sage Therapeutics Inc. (SAGE - Free Report) 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 - Free Report) , 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 - Free Report) received a Complete Response Letter from the FDA regarding its new drug application for ALKS 5461 for the adjunctive treatment of MDD.
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 - Free Report) , 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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Shares of Sage Therapeutics Inc. (SAGE - Free Report) 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 - Free Report) , 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 - Free Report) received a Complete Response Letter from the FDA regarding its new drug application for ALKS 5461 for the adjunctive treatment of MDD.
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 - Free Report) , 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.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year. These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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