Axsome Therapeutics
221 articles about Axsome Therapeutics
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Axsome Therapeutics to Host Sunosi® Investor Update Virtual Event
6/22/2022
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will host a virtual event on Tuesday, June 28, 2022 at 9:00 AM EDT/
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The Phase II/III Aria Study was unsuccessful in achieving statistical significance on the primary endpoint or any secondary objectives, according to Praxis.
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It was a busy, busy week for clinical trial news and updates, largely driven by the annual ASCO meeting taking place June 3-7 in Chicago.
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Axsome Therapeutics Announces Results of the SUPPORT Survey of Patients with Major Depressive Disorder Presented at the American Society of Clinical Psychopharmacology Association (ASCP) 2022 Annual Meeting
6/6/2022
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the results of the SUPPORT (Studying the Impact of Patient Treatment Experiences on Patient Hope for Future Major Depressive Disorder Pharmacotherapies).
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Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder
6/2/2022
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that treatment with AXS-05 (dextromethorphan-bupropion) rapidly and significantly reduced anhedonic symptoms in the GEMINI Phase 3 trial in major depressive disorder (MDD).
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Axsome Therapeutics published results of its Phase III trial of AXS-05 that demonstrated rapid, substantial and statistically significant improvement in depressive symptoms.
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Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacology 2022 Annual Meeting
6/1/2022
Axsome Therapeutics, Inc. announced positive results from the long-term, open-label EVOLVE trial of AXS-05 in major depressive disorder.
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Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry
5/31/2022
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the publication on May 30, 2022 of the results from the pivotal GEMINI Phase 3 clinical trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD).
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Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical PsychiatryAXS-05
5/31/2022
Axsome Therapeutics, Inc. today announced the publication on May 30, 2022 of the results from the pivotal GEMINI Phase 3 clinical trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD).
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Closing out the month of May, plenty of companies presented or announced clinical trial updates and news. Here’s a look.
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Axsome Therapeutics announced that it published the results of its Ascend Phase-II clinical trial of AXS-05 to treat Major Depressive Disorder in The American Journal of Psychiatry.
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Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry
5/18/2022
Axsome Therapeutics, Inc. today announced the publication of the results from the pivotal ASCEND Phase 2 clinical trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD).
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Jazz Pharmaceuticals Completes U.S. Divestiture of Sunosi® (solriamfetol) to Axsome Therapeutics
5/9/2022
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it has completed the divestiture of Sunosi ® (solriamfetol) in the U.S. to Axsome Therapeutics, Inc. (Nasdaq: AXSM).
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Axsome Therapeutics Completes U.S. Acquisition of Sunosi® (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
5/9/2022
Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced the completion of its U.S. acquisition of Sunosi® from Jazz Pharmaceuticals.
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The FDA is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and Monday morning held bad news for Coherus, Junshi and Axsome.
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Axsome Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update
5/2/2022
Axsome Therapeutics, Inc. today reported financial results for the first quarter ended March 31, 2022.
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Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine
5/2/2022
Axsome Therapeutics, Inc. today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.
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Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.
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Axsome Therapeutics to Report First Quarter 2022 Financial Results on May 2, 2022
4/25/2022
Axsome to host conference call and webcast on Monday, May 2, 2022 at 8:00 AM Eastern Time.
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Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.