Shares of
Sage Therapeutics, Inc.
SAGE
were up 9.5% on Jun 1 after management announced that the phase III SKYLARK study, which evaluated its investigational oral drug zuranolone in women with postpartum depression (PPD), achieved its primary and key secondary endpoints. The drug is being developed in collaboration with
Biogen Inc.
BIIB
.
The SKYLARK study achieved its primary endpoint of zuranolone achieving a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15 over placebo. This was measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score.
This study also met its secondary endpoint of improvement in depression symptoms, as measured by CFB in HAMD-17 total score, at days 3, 28 and 45. Moreover, the study demonstrated a statistically significant improvement in another key secondary endpoint of CFB in the Clinical Global Impression Severity (CGI-S) scale at Day 15. The CGI-S scale rates the severity of a person’s disease at the time of assessment.
Shares of Sage Therapeutics have declined 19.8% in the year so far compared with the
industry
’s 24.6% decrease.
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The SKYLARK study is part of the broader NEST clinical program, which is evaluating zuranolone for PPD indication. Sage Therapeutics along with Biogen already conducted the phase III ROBIN study, which evaluated the efficacy, safety and pharmacokinetics of zuranolone for treating PPD in women. Like the SKYLARK study, the ROBIN study met is primary endpoint.
If approved, zuranolone will be the first oral medication for PPD indication.
PDD is one of the most common medical complications seen in women during and after pregnancy. Per management, an estimated one of eight women who give birth in the United States or nearly 500,000 women, annually, are affected by PDD.
Apart from PDD, zuranolone is being evaluated in the LANDSCAPE clinical program for treating major depressive disorder (MDD). Both Sage Therapeutics and Biogen already initiated a rolling submission in second-half 2022 with the FDA for a new drug application, which seeks approval for zuranolone to treat MDD. A regulatory filing for the drug to address PDD is expected by early 2023.
Sage Therapeutics’ partnership with Biogen is part of a global collaboration agreement reached between both companies in 2020. Per the terms of the agreement, both SAGE and BIIB will jointly develop and commercialize zuranolone (for MDD and PDD) as well as SAGE-324 (for essential tremor and other neurological disorders).
Zacks Rank & Stocks to Consider
Sage Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are
Aeglea BioTherapeutics
AGLE
and
Sesen Bio
SESN
. While Sesen Bio currently sports a Zacks Rank #1 (Strong Buy), Aeglea BioTherapeutics carries a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here
.
Sesen Bio’sloss per share estimates for 2022 have declined from 33 cents to 32 cents in the past 30 days. Shares of SESN have dropped 28.4% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.9%. In the last reported quarter, SESN delivered an earnings surprise of 100%.
Aeglea BioTherapeutics’ loss per share estimates for 2022 have narrowed from $1.44 to $1.16 in the past 30 days. The same for 2023 has narrowed from $1.49 to $1.04 in the same period. Shares of AGLE have plunged 68.4% year to date.
Earnings of Aeglea BioTherapeutics beat estimates in two of the last four quarters and missed the mark on the remaining two occasions, the average surprise being 9.5%. In the last reported quarter, AGLE witnessed a negative earnings surprise of 5.7%.
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