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Sage Therapeutics ™ Sage Therapeutics Announces Third Quarter 2021 Financial Results and Highlights Pipeline and Business Progress November 2 , 2021 NDA submission for zuranolone for the treatment of MDD expected to be filed in the second half of 2022 , with rolling submission planned to begin in early 2022 CORAL Study primary endpoint updated , in line with goal of study to demonstrate rapid reduction in depressive symptoms and benefits throughout treatment period when co - initiated with standard antidepressants Continued pipeline progress demonstrated across brain health franchises , with plans to initiate three Phase 2 studies across SAGE - 324 and SAGE - 718 programs Conference call today at 8:00 a.m. ET CAMBRIDGE , Mass .-- ( BUSINESS WIRE ) -- Nov . 2 , 2021-- Today , Sage Therapeutics , Inc. ( Nasdaq : SAGE ) , a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain , reported business highlights and financial results for the third quarter ended September 30 , 2021 . " I'm proud of the substantial progress we've made this quarter , including a successful pre - NDA meeting with the FDA for zuranolone . We're excited to have reached alignment with the Agency and to have what we believe is a clear , efficient path forward for zuranolone . We're now one step closer toward our goal of helping people living with MDD and PPD by bringing them a treatment that in clinical development to date has demonstrated rapid and sustained reductions in depressive symptoms with a well - tolerated safety profile , " said Barry Greene , chief executive officer at Sage Therapeutics . " It is an exciting time here at Sage , and I look forward to sharing additional updates as we progress with our work on the NDA filing for zuranolone , as well as expected initiation of three new Phase 2 studies for SAGE - 324 and SAGE - 718 . " Third Quarter 2021 and Recent Portfolio Updates Sage is advancing a portfolio of clinical programs featuring internally discovered novel chemical entities with the potential to become differentiated products designed to improve brain health by targeting the GABAA and NMDA receptor systems . Dysfunction in these systems is thought to be at the core of numerous neurological and neuropsychiatric disorders . Depression Franchise Sage's depression franchise features zuranolone , Sage's next - generation positive allosteric modulator ( PAM ) of GABA A receptors being evaluated in clinical development as a treatment for various affective disorders , and ZULRESSOⓇ ( brexanolone ) CIV injection , approved by the U.S. Food and Drug Administration ( FDA ) as the first treatment specifically indicated for postpartum depression ( PPD ) . Zuranolone has received breakthrough therapy designation from the FDA for the treatment of major depressive disorder ( MDD ) . Zuranolone is being evaluated as a potential rapid - acting , durable , once - daily , two - week treatment for MDD and PPD in the LANDSCAPE and NEST clinical development programs , respectively . Sage and Biogen recently announced their plan to submit a New Drug Application ( NDA ) to the FDA for zuranolone in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of MDD and an additional filing for PPD is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA , including a pre - NDA meeting held this fall . The meeting reinforced Sage's belief that data from the MDD - 201 , ROBIN , and WATERFALL Studies and the Shionogi Phase 2 study along with supportive data from the MOUNTAIN Study will be sufficient for Sage to file in MDD . The planned initial NDA will focus on MDD and will also include data from the ongoing pharmacology and clinical studies ( CORAL and SHORELINE Studies ) . An additional associated NDA for PPD is expected to be filed following the SKYLARK Study readout . If planned efforts are successful and zuranolone is approved , Sage and its collaboration partner , Biogen , plan to commence marketing for the approved indications as soon as possible . The review cycles may potentially allow commercialization of both indications simultaneously , if approved . Additionally , Sage today announced that the primary endpoint for the CORAL Study ( HAMD - 17 change from baseline ) will be measured at Day 3. The CORAL Study is an adjunctive use study in MDD designed to demonstrate the benefit of zuranolone when co - initiated with a new antidepressant therapy , including rapid reduction in depressive symptoms as well as benefits across the treatment period with a well - tolerated safety profile . The Company believes that , if successful , the Day 3 primary endpoint and key secondary endpoints , including other timepoints , will provide additional data that may be important to inform real world use in MDD if zuranolone is approved . In October , Sage and Biogen announced that data presented at the 34th European College of Neuropsychopharmacology ( ECNP ) Congress further support the differentiated profile seen to date with zuranolone in clinical development , including a rapid and sustained reduction in depressive symptoms and a unique and well - tolerated safety profile . Further , in a pooled analysis from the LANDSCAPE and NEST programs , zuranolone treatment led to rapid and sustained improvement in quality of life and overall health and well - being at Day 15 that continued to increase through Day 42 , as measured by SF - 36v2 , a patient self - reported measure of general health . Sage also presented data at the 34th Psych Congress showing that