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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