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Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting
May 06, 2019 06:30 ET | Axsome Therapeutics, Inc.
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...
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Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Major Depressive Disorder
March 27, 2019 07:00 ET | Axsome Therapeutics, Inc.
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...
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BeiGene Receives U.S. FDA Breakthrough Therapy Designation for Zanubrutinib in Mantle Cell Lymphoma
January 14, 2019 16:15 ET | BeiGene, LTD.
CAMBRIDGE, Mass. and BEIJING, China, Jan. 14, 2019 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and...