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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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...
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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 | 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...
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Kiniksa Announces Breakthrough Therapy Designation for Rilonacept for the Treatment of Recurrent Pericarditis
November 20, 2019 08:00 ET | Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, Nov. 20, 2019 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...