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SAGE

Sage Therapeutics

$91.90

2.11 (2.35%)

06:03
12/07/17
12/07
06:03
12/07/17
06:03

Sage Therapeutics reports 'positive' results from Phase 2 trial of SAGE-217

Sage Therapeutics announced positive top-line results from the Phase 2, double-blind, placebo-controlled clinical trial of SAGE-217 in the treatment of 89 adult patients with moderate to severe major depressive disorder. In the trial, treatment for 14 days with SAGE-217 was associated with a statistically significant mean reduction in the Hamilton Rating Scale for Depression 17-Item total score from baseline to Day 15 (the time of the primary endpoint) of 17.6 points for SAGE-217, compared to 10.7 for placebo (pless than0.0001). Statistically significant improvements were observed in the HAM-D compared to placebo by the morning following the first dose through Week 4 and the effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at Week 6. At Day 15, 64 percent of patients who received SAGE-217 achieved remission, defined as a score of 7 or less on the HAM-D scale, compared with 23 percent of patients who received placebo (p=0.0005). Other secondary endpoints were all similarly highly significant at Day 15 (pless than or equal to0.002). SAGE-217 was generally well-tolerated with no serious or severe adverse events; the most common adverse events in the SAGE-217 group were headache, dizziness, nausea, and somnolence. A low rate of discontinuations due to AEs was reported; overall reports of AEs were similar between drug (53%) and placebo (46%), with a safety profile consistent with that seen in earlier trials. SAGE-217 was granted Fast Track Designation by the U.S. FDA in May 2017.

SAGE Sage Therapeutics
$91.90

2.11 (2.35%)

11/10/17
NEED
11/10/17
NO CHANGE
Target $100
NEED
Buy
Sage Therapeutics price target raised to $100 from $86 at Needham
Needham analyst Danielle Brill raised her price target on Sage Therapeutics to $100 and kept her Buy rating. Brill cites the company's IV brexanolone Phase 3 trials in moderate and severe postpartum depression achieving primary efficacy endpoints, saying that while she had modest expectations for overall commercial opportunity w/ brexanolone, the drug does highlight an unmed need as the first treatment approved for PPD. The analyst adds that there is also significant upside opportunity for Sage shares w/ Phase 2 MDD data reporting expected out by year-end.
11/15/17
RHCO
11/15/17
NO CHANGE
Target $116
RHCO
Buy
Sage Therapeutics price target raised to $116 from $82 at SunTrust
SunTrust analyst Edward Nash raised his price target on Sage Therapeutics to $116 based on the recent positive top-line data from both Phase III trials for brexanolone in post-partum depression. Nash says he has increased his probability of success estimate for the treatment to 80% from 70%, with the remaining 20% based on regulatory risk. The analyst also adjusted his projections for the drug efficacy in Major Depressive Disorder, keeping his Buy rating on Sage Therapeutics.
11/17/17
BMOC
11/17/17
NO CHANGE
Target $112
BMOC
Outperform
Sage Therapeutics price target raised to $112 from $80 at BMO Capital
BMO Capital analyst Gary Nachman raised his price target for Sage Therapeutics to $112 saying he received "very positive" feedback from two leading psychiatrists on the brexanolone Phase 3 data in both severe and moderate postpartum depression. The shares closed yesterday up 20c to $85.67. The physicians are "very impressed" by the rapid onset and good safety profile for brexanolone and expect to use the drug a lot, Nachman tells investors in a research note. The psychiatrists also expressed their belief in a high probability of success for the upcoming SAGE-217 data in postpartum depression and major depressive disorder, the analyst adds. He sees a good risk/reward into those catalysts at current share levels. Nachman reiterates an Outperform rating on Sage.
11/27/17
RBCM
11/27/17
NO CHANGE
Target $137
RBCM
Outperform
Sage Therapeutics price target lowered to $137 from $145 at RBC Capital
RBC Capital analyst Brian Abrahams lowered his price target on Sage Therapeutics to $137 from $145, modelling a 40% probability of success and the possibility of more non-responders in the Phase 2B SAGE-217 for major depressive disorder - MDD - treatment. Abrahams keeps Outperform rating, saying the risk-reward profile is still attractive given the likelihood of "many additional shots on goal even if MDD fails", as negative outcome would not necessarily impact the overall prospects of the oral program in post-partum depression.

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