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Axsome Therapeutics Inc (AXSM.OQ)

AXSM.OQ on NASDAQ Stock Exchange Global Market

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17 Jul 2019
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Latest Key Developments (Source: Significant Developments)

Axsome Therapeutics Says Enrolling 2 Open-Label Studies To Build Safety Databases To Support Filing Of NDA For Axs-05 In Major Depressive Disorder Treatment
Thursday, 11 Jul 2019 

July 11 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS - ENROLLING 2 OPEN-LABEL STUDIES TO BUILD SAFETY DATABASES TO SUPPORT FILING OF NDA FOR AXS-05 IN MAJOR DEPRESSIVE DISORDER TREATMENT.AXSOME THERAPEUTICS - ENROLLING 2 OPEN-LABEL STUDIES TO BUILD SAFETY DATABASES OF PATIENTS TO SUPPORT FILING OF NDA FOR AXS-07 IN ACUTE TREATMENT OF MIGRAINE.AXSOME THERAPEUTICS - FOR EACH OF STUDIES, PLANS TO TREAT AT LEAST 300 PATIENTS FOR AT LEAST SIX MONTHS AND AT LEAST 100 PATIENTS FOR ONE YEAR.  Full Article

Axsome Therapeutics Reports Q1 2019 Results
Thursday, 9 May 2019 

May 9 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE.Q1 LOSS PER SHARE $0.32.Q1 EARNINGS PER SHARE ESTIMATE $-0.30 -- REFINITIV IBES DATA.  Full Article

Axsome Therapeutics Reports Q4 Loss Per Share $0.32
Thursday, 14 Mar 2019 

March 14 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE.Q4 LOSS PER SHARE $0.32.Q4 EARNINGS PER SHARE ESTIMATE $-0.30 -- REFINITIV IBES DATA.AXSOME THERAPEUTICS - SEES CURRENT CASH WILL BE SUFFICIENT TO FUND ANTICIPATED OPERATIONS, BASED ON CURRENT OPERATING PLANS, INTO AT LEAST Q4 2021.AT DECEMBER 31, 2018, AXSOME HAD $14.0 MILLION OF CASH.  Full Article

Axsome Therapeutics Receives FDA Agreement Under Special Protocol Assessment For Momentum Phase 3 Trial Of Axs-07 In Migraine
Wednesday, 6 Feb 2019 

Feb 6 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS RECEIVES FDA AGREEMENT UNDER SPECIAL PROTOCOL ASSESSMENT (SPA) FOR THE MOMENTUM PHASE 3 TRIAL OF AXS-07 IN MIGRAINE.AXSOME THERAPEUTICS INC - TRIAL INITIATION ANTICIPATED 1Q 2019.AXSOME THERAPEUTICS INC - FDA AGREEMENT ACHIEVED ON PHASE 3 TRIAL DESIGN, ENDPOINTS, AND STATISTICAL APPROACH.AXSOME THERAPEUTICS INC - TOPLINE RESULTS EXPECTED WITHIN APPROXIMATELY ONE YEAR OF TRIAL INITIATION..  Full Article

Axsome Therapeutics Provides Year End 2018 Clinical Update
Thursday, 27 Dec 2018 

Dec 27 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS PROVIDES YEAR END 2018 CLINICAL UPDATE.AXSOME THERAPEUTICS INC - PHASE 3 TRIAL OF AXS-07 IN ACUTE MIGRAINE ON TRACK TO START IN 1Q 2019.AXSOME THERAPEUTICS INC - PHASE 3 RESULTS OF AXS-05 IN TREATMENT RESISTANT DEPRESSION ON TRACK FOR 1Q 2019.AXSOME THERAPEUTICS INC - PHASE 2 RESULTS OF AXS-05 IN MAJOR DEPRESSIVE DISORDER ON TRACK FOR EARLY JANUARY 2019.  Full Article

Axsome Therapeutics Announces Positive Outcome Of Interim Analysis Of AXS-05
Monday, 10 Dec 2018 

Dec 10 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS ANNOUNCES POSITIVE OUTCOME OF INTERIM ANALYSIS OF ADVANCE-1 PHASE 2/3 TRIAL OF AXS-05 IN ALZHEIMER’S DISEASE AGITATION.AXSOME THERAPEUTICS INC - IDMC RECOMMENDS CONTINUATION OF TRIAL EVALUATING AXS-05 VERSUS PLACEBO IN ALZHEIMER'S DISEASE AGITATION.AXSOME THERAPEUTICS INC - IDMC RECOMMENDS NO FURTHER ENROLLMENT TO SINGLE-AGENT BUPROPION ARM.AXSOME THERAPEUTICS INC - IDMC RECOMMENDS NO FURTHER ENROLLMENT TO SINGLE-AGENT BUPROPION ARM.AXSOME THERAPEUTICS INC - AXSOME INTENDS TO FOLLOW IDMC'S RECOMMENDATIONS..AXSOME THERAPEUTICS INC - IDMC DID NOT INDICATE THAT THERE WERE ANY SAFETY CONCERNS IN STUDY.AXSOME THERAPEUTICS INC - AXS-05 HAS BEEN GRANTED FDA FAST TRACK DESIGNATION FOR TREATMENT OF AD AGITATION.  Full Article

U.S. FDA Says Approved Jazz Pharmaceutical's Narcolepsy Drug, Xyrem, For Pediatric Patients
Friday, 26 Oct 2018 

Oct 26 (Reuters) - U.S. Food and Drug Administration::U.S. FDA - APPROVED XYREM FOR TREATMENT OF CATAPLEXY AND EXCESSIVE DAYTIME SLEEPINESS IN PEDIATRIC PATIENTS WITH NARCOLEPSY.  Full Article

Axsome Therapeutics Receives FDA Orphan Drug Designation For Axs-12 For The Treatment Of Narcolepsy
Wednesday, 17 Oct 2018 

Oct 17 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AXS-12 FOR THE TREATMENT OF NARCOLEPSY.AXSOME THERAPEUTICS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AXS-12 FOR THE TREATMENT OF NARCOLEPSY.AXSOME THERAPEUTICS INC - TOP-LINE RESULTS ANTICIPATED IN FIRST HALF OF 2019.AXSOME THERAPEUTICS INC - PLANS TO INITIATE A PHASE 2 TRIAL OF AXS-12 FOR TREATMENT OF SYMPTOMS OF NARCOLEPSY IN Q4 OF THIS YEAR.  Full Article

Axsome Therapeutics Q2 Loss Per Share $0.32
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE.Q2 LOSS PER SHARE $0.32.INTERIM ANALYSIS RESULTS FROM TWO PHASE 3 TRIALS AND TOPLINE RESULTS FROM ONE PHASE 2 TRIAL OF AXS-05 ANTICIPATED IN 4Q 2018.AT JUNE 30, 2018, AXSOME HAD $20.4 MILLION OF CASH COMPARED TO $26.6 MILLION OF CASH AT MARCH 31, 2018.BELIEVES CASH AT JUNE 30, TO BE SUFFICIENT TO FUND ANTICIPATED OPERATIONS INTO Q3 OF 2019.  Full Article

Axsome Therapeutics Appoints Nick Pizzie, Cpa, Mba, As Chief Financial Officer
Thursday, 19 Apr 2018 

April 19 (Reuters) - Axsome Therapeutics Inc ::AXSOME THERAPEUTICS APPOINTS NICK PIZZIE, CPA, MBA, AS CHIEF FINANCIAL OFFICER.AXSOME THERAPEUTICS INC - PIZZIE WILL REPLACE JOHN GOLUBIESKI, CFO, WHO SUBMITTED HIS RESIGNATION ON APRIL 13, 2018.AXSOME THERAPEUTICS INC - PIZZIE WILL REPLACE JOHN GOLUBIESKI, CFO, WHO SUBMITTED HIS RESIGNATION ON APRIL 13, 2018, EFFECTIVE MAY 9, 2018.  Full Article