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EX - 99.1 2 d390904dex991.htm EX - 99.1 Sage Therapeutics Announces First Quarter 2021 Financial Results and Highlights Pipeline and Business Progress Exhibit 99.1 Sage Therapeutics ™ Company on - track to initiate placebo - controlled Phase 2 trial with SAGE - 718 in Huntington's disease in late 2021 , as the target for the first indication for SAGE - 718 , following encouraging signals in Phase 1 data PARADIGM Study with SAGE - 718 showed improved performance from baseline on multiple tests of executive function over 14 days of treatment in patients with Parkinson's disease cognitive impairment , further supporting development in disorders associated with cognitive dysfunction Positive topline data from Phase 2 KINETIC Study showed statistically significant reduction in tremor score with SAGE - 324 compared to placebo at Day 29 in adults with essential tremor Continued positive data demonstrated for the 30 and 50 mg doses of zuranolone in open - label SHORELINE Study of zuranolone in patients with major depressive disorder Conference call today at 8:00 a.m. ET CAMBRIDGE , Mass . - May 4 , 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 first quarter ended March 31 , 2021 . " Sage started 2021 with significant advances across our depression , neurology and neuropsychiatry franchises , and the progress we've made so far this year sets us up for near- , medium- and long - term value creation opportunities as we further advance our deep organic pipeline , " said Barry Greene , chief executive officer at Sage Therapeutics . “ In the first quarter alone , we demonstrated the significant potential of our innovative development - stage therapeutics that modulate the GABA and NMDA pathways , through the positive clinical data demonstrated in studies of zuranolone , SAGE - 324 and now SAGE - 718 . We are making great progress toward our goal of becoming the leading brain health company and a top - tier biopharmaceutical company , with multiple upcoming catalysts that I believe represent important steps on our mission of delivering medicines that matter to address the ongoing crisis in brain health . " First 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 brain health 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 ) . Sage is jointly developing zuranolone in the U.S. with Biogen . 1