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.
Cambridge
Cambridgeshire
United-kingdom
United-states
Canada
Bluerock
Nova-scotia
America
Joachim-fruebis
Bayer-pharmaceuticals
Development-officer
Bayer-ag