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BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinsons Disease

Posted July 19th, 2021 for Bayer CAMBRIDGE, Mass., July 19, 2021 - BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly owned subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DA01 for advanced Parkinson’s disease (PD). DA01, BlueRock’s pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase 1 study. The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate’s development plan as well as eligibility for accelerated approval and priority review.

Global Cell Therapy Markets, 2015-2020, 2020-2025F, 2030F: Stem Cell Therapy, Cell Vaccine, Adoptive Cell Transfer (ACT), Fibroblast Cell Therapy, Chondrocyte Cell Therapy

Global Cell Therapy Markets, 2015-2020, 2020-2025F, 2030F: Stem Cell Therapy, Cell Vaccine, Adoptive Cell Transfer (ACT), Fibroblast Cell Therapy, Chondrocyte Cell Therapy
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