Business
Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update
Two NDA submissions, for AXS-05 in MDD and for AXS-07 in migraine, on track for 4Q 2020 Enrollment completed for both the AXS-05 Phase 3 long-term safety
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"Two NDA submissions, for AXS-05 in MDD and for AXS-07 in migraine, on track for 4Q 2020\n Enrollment completed for both the AXS-05 Phase 3 long-term safety trial in MDD, and for the AXS-07 Phase 3 long-term safety trial in migraine Results from three Phase 2 open-label efficacy trials of AXS-05 in TRD, antidepressant unresponsive MDD, and suicidal ideation, expected in 4Q 2020 Phase 3 trials for AXS-05 in Alzheimer’s disease agitation and for AXS-12 in narcolepsy on track for 4Q 2020 Three FDA Breakthrough Therapy designations, in MDD, Alzheimer’s disease agitation, and narcolepsy, highlight Axsome’s broad, differentiated, late-stage CNS pipeline Company to host conference call today at 8:00 AM Eastern NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the second quarter ended June 30, 2020. “Axsome is committed to developing potentially life-changing medicines for patients living with difficult-to-treat CNS disorders. Over the past several months, we achieved a number of significant clinical and regulatory milestones including receipt of Breakthrough Therapy designations from the FDA for AXS-05 for the treatment of Alzheimer’s disease agitation, and for AXS-12 for the treatment of cataplexy in patients with narcolepsy. Our industry-leading, late-stage CNS pipeline has now been granted three FDA Breakthrough Therapy designations, highlighting the potential for significant advances in patient care,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We remain on track to submit two New Drug Applications to the FDA, for AXS-05 in depression and for AXS-07 in migraine, by year-end. We expect to launch the second pivotal trial of AXS-05 in Alzheimer’s disease agitation as well as pivotal trials of AXS-12 in narcolepsy by year end. We also unveiled three new Phase 2 open-label efficacy trials of AXS-05 in three different clinically pertinent depressed populations. These trials are designed to further characterize the novel antidepressant profile of AXS-05 across a broad spectrum of patients with major depressive disorder, with results expected in the fourth quarter. Having achieved a number of key milestones and with more on the horizon...