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May 06, 2019 06:30 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting

Previously completed active-controlled ASCEND trial in MDD now considered as pivotal; sufficient with ongoing STRIDE-1 Phase 3 trial for NDA in MDD Target randomization for STRIDE-1 Phase 3 trial...
April 29, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics To Report First Quarter 2019 Financial Results On May 9, 2019

Axsome to host conference call and webcast on Thursday, May 9, 2019 at 8:00 AM Eastern Time NEW YORK, April 29, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage...
April 15, 2019 06:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Smoking Cessation

Demonstrated statistically significant reduction in daily smoking compared to active comparator (p=0.0016) Trial conducted in collaboration with Duke University NEW YORK, April 15, 2019 (GLOBE...
March 27, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Major Depressive Disorder

Designation offers potential for expedited development and review NEW YORK, March 27, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company...
March 14, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update

Company to host conference call today at 8:00 AM Eastern NEW YORK, March 14, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing...
March 06, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Secures $24 Million Growth Capital Loan Facility Led by Silicon Valley Bank

$46 million total raised in recent financings extends cash runway into at least 4Q 2021 Current financial position fully funds all five ongoing clinical trials NEW YORK, March 06, 2019 (GLOBE...
March 05, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics to Report Fourth Quarter and Full Year 2018 Financial Results on March 14, 2019

Axsome to host conference call and webcast on Thursday, March 14, 2019 at 8:00 AM Eastern Time NEW YORK, March 05, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a...
March 04, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Initiates MOMENTUM Phase 3 Trial of AXS-07 in Migraine

First patient enrolled in the MOMENTUM study Trial being conducted under FDA Special Protocol Assessment (SPA) Topline results anticipated in 1Q 2020 NEW YORK, March 04, 2019 (GLOBE NEWSWIRE) --...
February 06, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Receives FDA Agreement under Special Protocol Assessment (SPA) for the MOMENTUM Phase 3 Trial of AXS-07 in Migraine

FDA agreement achieved on Phase 3 trial design, endpoints, and statistical approach Trial to enroll patients with a history of inadequate response to prior migraine treatments Trial initiation...
January 30, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.

Axsome Therapeutics Initiates Phase 2 Trial of AXS-12 in Narcolepsy

Topline results anticipated in 2Q 2019 NEW YORK, Jan. 30, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies...