In a report published Thursday, Canaccord Genuity analysts maintained a Buy rating on SAGE Therapeutics Inc SAGE, while raising the price target from $58 to $85, to reflect a higher probability of success for SAGE-547.
The analysts believe SAGE-547 is poised to hit the primary endpoint in the upcoming Phase 3 STATUS trial, "which is successful weaning off of anesthesia and all AE drugs without recurrence of SE within 24 hours, due to continued positive data in its Phase 1/2 trials."
The Phase 3 trial is scheduled to enroll 126 patients to either SAGE-547 versus standard of care third-line anti-seizure agents. The trial would continue for six days and the top-line data can be expected in mid-2016. "Importantly, the study will include a crossover and retreatment with a higher dose if no initial response, which we believe may provide a more definitive demonstration of efficacy," the analysts said.
Phase 2 data for SAGE-547 in Essential Tremor (ET) and severe PostPartum Depression (PPD) by mid-215 could be a near-term catalyst, provided they exhibit early efficacy.
In the report Canaccord Genuity noted, "Although data are ~12 months away, we believe that finalization of the Phase 3 design and enrollment will increase investor diligence near term. We believe the Phase 3 trial design of a placebo-controlled study vs. an open-label historical control will provide unambiguous evidence of efficacy for SAGE-547 vs. placebo, especially due to the high level of confounding variables that may occur in this complicated patient population if an open-label study was run."
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