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EX - 99.1 2 d183419dex991.htm EX - 99.1 Sage Therapeutics Announces Second Quarter 2021 Financial Results and Highlights Pipeline and Business Progress Exhibit 99.1 Sage Therapeutics Announced positive topline data from pivotal WATERFALL Study of zuranolone in patients with MDD showing statistically significant and clinically meaningful reduction in depressive symptoms at Day 15 , primary endpoint Continued pipeline expansion and acceleration advancing all three brain health franchises , including first patient dosed in SAGE - 718 PARADIGM Parkinson's disease Study Part B and initiation of Phase 1 program for SAGE - 689 Updated enrollment guidance for Phase 3 SKYLARK Study of zuranolone in women with PPD with topline data now expected mid - 2022 Company announces REDWOOD and RAINFOREST Studies not expected to be required for a potential zuranolone NDA submission Conference call today at 8:00 a.m. ET CAMBRIDGE , Mass . – August 3 , 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 second quarter ended June 30 , 2021 . " Sage has made incredible progress on our mission to become the leader in brain health in the first half of 2021 , setting us up for multiple near - mid and long - term catalysts . " said Barry Greene , chief executive officer , Sage Therapeutics . " Our goal of making medicines that matter for people with brain health disorders is more important than ever , and we are committed to delivering innovative therapies . The LANDSCAPE and NEST programs for zuranolone are examples of Sage's unique approach to designing integrated clinical development strategies that we believe will enable us to bring paradigm shifting treatments to market and address the greatest unmet needs for patients . I look forward to providing further updates on zuranolone and the rest of Sage's robust pipeline in the second half of the year . " Second 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 GABAA 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 evaluating as a potential rapid - acting , durable , two - week treatment for PPD and MDD in the NEST and LANDSCAPE clinical trial programs . 1 Sage and Biogen , its collaborator on zuranolone and SAGE - 324 , recently announced that the WATERFALL Study , a pivotal , Phase 3 , double - blind , randomized , placebo - controlled study evaluating the efficacy and safety of zuranolone 50 mg in adults 18 to 64 years with MDD , met its primary endpoint demonstrating statistically significant and clinically meaningful improvement in depressive symptoms compared with placebo at Day 15 as assessed by the 17 - item Hamilton Rating Scale for Depression ( HAMD - 17 ) total score .