Biotech Event – SAGE Therapeutics (SAGE)
SAGE Therapeutics (SAGE) with a key catalyst coming up in Q4 with Phase 3 data for the SHORELINE study of zuranolone in MDD. The study looks at the drug in both the 30mg and 50mg doses and they’ve started trials in higher doses as well. The drug is a once-daily NSA GABA receptor which looks to alter the signaling pathway of the brain and CNS. Zuranolone failed in December to meet its primary endpoint in the MOUNTAIN study of acute rapid response therapy for MDD but the difference with SHORELINE is expected to be the use of both retreatment and a higher dosage. MDD is a brain disorder often called simply depression which leads to impaired cognitive function and a slowdown/lack of interest. MDD is also a gateway to other high-risk ailments like heart disease. MDD impacts 17M people in the US. The current SoC is a chronic antidepressant use and SAGE sees advantages for zuranolone being a two-week treatment period. BAML has a buy rating and $68 PT for shares. They think zuranolone in MDD contributes $32/share with risk-adj. peak sales of $1.1bn in 2034. Wedbush upgrading to Outperform on 9/11 after preliminary safety data for SHORELINE showed strong safety and bodes well for the key Phase III depression data in 2021.