Sage Therapeutics Drops Two Zuranolone Depression Trials Deemed Unnecessary For Approval

Tucked in the Q2 earnings release, Sage Therapeutics Inc SAGE has terminated two long-suspended Phase 3 zuranolone trials in major depressive disorder (MDD).

What Happened: After talks with the FDA, the decision led the Company to believe it can seek approval without the data. 

Sage paused enrollment in its REDWOOD and RAINFOREST trials in Q4 of 2019 as part of the revision of its strategy in light of the failure of the Phase 3 MOUNTAIN Study in major depressive disorder. 

REDWOOD was designed to test a fixed schedule intermittent dosing of zuranolone 30mg, while the RAINFOREST trial involved the same dose but enrolled patients with MDD and co-morbid insomnia.

Why It Matters: In addition to two Phase 3 placebo-controlled studies (CORAL in MDD and SKYLARK in postpartum depression), Sage is still conducting an open-label Phase 3 in MDD known as SHORELINE.

Sage revealed a delay to the Phase 3 SKYLARK postpartum depression (PPD) study. It now expects to have top-line data from the study around mid-2022. 

The biotech attributed the delay to “a slower than anticipated pace of enrollment in the study, due to a lower number of women seeking care for PPD and a lower rate of childbirth during the pandemic.” 

Sage also said it had terminated the brexanolone Phase 3 trial in patients with COVID-19 related acute respiratory distress syndrome, as the trial did not meet enrollment expectations.

Q2 financials: Sales of $1.6 million missed the consensus of $2 million, up 51% Y/Y. EPS loss of $(1.83) was narrower than $(2.63) posted last year but missed the consensus of $(1.69). 

Cash, cash equivalents, and marketable securities stood at $1.9 billion.

Price Action: SAGE shares are down 2.47% at $42.22 during the market session on the last check Tuesday.

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