Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting
August 31, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Previously completed positive, pivotal ADVANCE-1 trial sufficient with single additional Phase 3 efficacy trial for NDA in Alzheimer’s disease agitation Initiation of Phase 3, placebo-controlled,...
Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update
August 10, 2020 07:05 ET
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Axsome Therapeutics, Inc.
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 trial in MDD, and for the AXS-07 Phase 3...
Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program
August 10, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Enrollment complete in the COMET Phase 3 long-term safety trial of AXS-05 in MDD; NDA filing on track for 4Q 2020 Results from three Phase 2 open-label efficacy trials of AXS-05 in TRD,...
Axsome Therapeutics to Report Second Quarter 2020 Financial Results on August 10, 2020
July 30, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Axsome to host conference call and webcast on Monday, August 10, 2020 at 8:00 AM Eastern Time NEW YORK, July 30, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a...
Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder
July 13, 2020 07:00 ET
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Axsome Therapeutics, Inc.
NDA submission on track for 4Q 2020 NEW YORK, July 13, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management...
Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
June 26, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Designation offers potential for expedited development and review Axsome now granted two Breakthrough Therapy designations for AXS-05 for separate CNS indications NEW YORK, June 26, 2020 (GLOBE...
Axsome Therapeutics to Present at Upcoming Investor Conferences
June 04, 2020 07:00 ET
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Axsome Therapeutics, Inc.
NEW YORK, June 04, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS)...
Axsome Therapeutics Presents Data from GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder at the 2020 American Society for Clinical Psychopharmacology Annual Meeting
May 29, 2020 07:00 ET
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Axsome Therapeutics, Inc.
NEW YORK, May 29, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS)...
Axsome Therapeutics to Host 2020 Annual Meeting of Stockholders Virtually
May 26, 2020 07:00 ET
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Axsome Therapeutics, Inc.
NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS)...
Axsome Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update
May 08, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company Positive pivotal Phase 2/3 results for AXS-05 in Alzheimer’s disease agitation further deepen innovative...