Sage and Biogen's NDA for Depression Drug Gets Priority Review
Sage Therapeutics, Inc. SAGE and partner, Biogen Inc. BIIB jointly announced that the FDA has accepted their new drug application (NDA) filing for zuranolone, a rapid-acting, once-daily, oral treatment in adults with major depressive disorder (MDD) and postpartum depression (PPD). Additionally, the FDA has granted priority review status to the NDA with a PDUFA date of Aug 5, 2023.
The NDA filing was based on results from the LANDSCAPE and NEST clinical development programs, along with a phase II study of zuranolone completed by Osaka-based Shionogi Pharmaceuticals in adults with MDD. The LANDSCAPE program includes five studies of zuranolone in adults with MDD, while the NEST program comprised two studies in adult women with PPD.
In the past year, shares of Sage Therapeutics have risen 3.5% against the industry’s decline of 13.8%.
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Per management, currently-approved therapies may take weeks or months to deliver results, but with zuranolone, Sage claims to be able to address depression symptoms quickly upon approval and provide physicians with a new treatment option.
Zuranolone is a neuroactive steroid that has a novel mechanism of action as a positive allosteric modulator of GABA-A receptors. Zuranolone is developed to target brain networks responsible for functions, such as mood, arousal, behavior and cognition.
MDD is a common, albeit serious mood disorder that causes a persistent feeling of sadness or loss of interest. Approximately 21 million adults have been estimated to be suffering from MDD in 2020 in the United States.
PDD is a common medical complication associated with pregnancy and can cause functional impairment, depression and loss of interest in the newborn with additional associated symptoms in women.
We note that Sage and Biogen entered into a global collaboration and license agreement for developing and commercializing potential breakthrough therapies in depression and movement disorders in November 2020. The agreement included the development of two candidates from Sage Therapeutics’ pipeline — zuranolone and SAGE-324. The mid-stage candidate, SAGE-324, is being developed for treating essential tremors.
Sage Therapeutics, Inc. Price and Consensus
Sage Therapeutics, Inc. price-consensus-chart | Sage Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Sage Therapeutics currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the medical drugs market are AlloVir, Inc. ALVR and ADMA Biologics, Inc. ADMA, both currently carrying a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AlloVir’s stock has fallen 21.3% this year so far. Loss estimates for AlloVir’s 2022 earnings have narrowed from $2.30 to $2.24 per share, while for 2023, the loss estimates have narrowed from $2.24 to $2.10 per share over the past 90 days. AlloVir reported an earnings surprise of 3.85% in the last reported quarter.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2022 loss per share has narrowed from 34 cents to 33 cents. During the same period, the loss estimate per share for 2023 has narrowed from 20 cents to 19 cents. In the past year, shares of ADMA Biologics have increased by 123.8%.
ADMA beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%.
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