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Sep 30, 2021
Sage Q3 2021 Earnings Report
Sage Therapeutics reported financial results for the third quarter of 2021 and highlighted pipeline and business progress.
Key Takeaways
Sage Therapeutics reported a net revenue of $1.4 million from sales of ZULRESSO in Q3 2021, compared to $1.6 million in the same period of 2020. The company's cash, cash equivalents, and marketable securities totaled $1.8 billion as of September 30, 2021. They are advancing their portfolio of clinical programs, notably zuranolone for MDD and PPD, and planning to file an NDA for zuranolone in the second half of 2022.
Sage and Biogen plan to submit an NDA to the FDA for zuranolone in the second half of 2022 for MDD, with an additional filing for PPD anticipated in the first half of 2023.
The primary endpoint for the CORAL Study (HAMD-17 change from baseline) will be measured at Day 3.
Sage plans to initiate an open-label study designed to demonstrate the safe-use administration of ZULRESSO in a patient’s home in the treatment of PPD.
Sage and Biogen advanced plans to initiate a Phase 2 dose-ranging study for SAGE-324 in ET in late 2021.
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