Axsome Therapeutics Initiates ADVANCE-2 Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation
September 08, 2022 07:00 ET
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Axsome Therapeutics, Inc.
NEW YORK, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous...
Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma
August 12, 2021 08:01 ET
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Coherus BioSciences, Inc.; Junshi Biosciences
SHANGHAI, China, and REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc....
FDA Grants Alkeus Pharmaceuticals Breakthrough Therapy Designation for ALK-001 (C20-D3-vitamin A) for the Treatment of Stargardt Disease
July 14, 2021 07:00 ET
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Alkeus Pharmaceuticals
Only drug to receive Breakthrough Therapy Designation for Stargardt DiseaseAlkeus Pharmaceuticals to discuss next steps toward filing an NDA with the FDAOngoing clinical trial of ALK-001 in dry...
Axsome Therapeutics Initiates ACCORD Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation
December 31, 2020 06:15 ET
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Axsome Therapeutics, Inc.
ACCORD is the second pivotal trial of AXS-05 in Alzheimer’s disease agitation No treatments are currently approved for Alzheimer’s disease agitation NEW YORK, Dec. 31, 2020 (GLOBE...
Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression
December 02, 2020 06:00 ET
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Axsome Therapeutics, Inc.
Rapid and substantial improvement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment Rapid and substantial...
Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting
September 21, 2020 07:00 ET
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Axsome Therapeutics, Inc.
Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021 Extensive patient safety database, previously obtained...
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 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...
Aprea Therapeutics Receives FDA Breakthrough Therapy Designation for APR-246 in Combination with Azacitidine for the Treatment of Myelodysplastic Syndromes (MDS) with a TP53 Mutation
January 30, 2020 07:30 ET
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Aprea Therapeutics
BOSTON, Jan. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate...