With a big assist from the FDA, Sage plots a swift march through PhIII for oral depression drug -- market cap swells $1B-plus
The FDA is putting Sage Therapeutics’ oral depression drug SAGE-217 on their inside track, blessing a fast-paced late-stage strategy that includes designating their ongoing study for post-partum depression a pivotal effort.
According to Sage execs $SAGE, regulators will demand only one more late-stage study, which will now get underway in a matter of months. Sage plans to evaluate “two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo in 450 patients with MDD, with four weeks of additional follow-up.”
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