Sage Therapeutics reported business highlights and financial results for the fourth quarter and full year ended December 31, 2021. The company ended the year with a cash balance of $1.7 billion and anticipates ending 2022 with approximately $1.3 billion. A rolling NDA submission for zuranolone in MDD is expected to begin in early 2022.
Positive topline data from WATERFALL and SHORELINE Studies supporting zuranolone efficacy and safety were announced in 2021.
Results from the Phase 3 CORAL Study in people with MDD met the trial objectives.
Sage and Biogen plan to submit an NDA to the U.S. Food and Drug Association (FDA) for zuranolone in the second half of 2022, with rolling submission planned to begin in early 2022.
SAGE-718 demonstrated improvements across multiple domains of cognition in Phase 1 and Phase 2a studies.
Sage anticipates cash, cash equivalents and marketable securities of approximately $1.3 billion at the end of 2022. The Company does not anticipate receipt of any milestone payments from collaborations in 2022. The Company believes its cash and cash equivalents, ongoing collaboration funding, and potential revenue, will support its operations into 2025.
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