PRVL - Prevail Therapeutics' gene therapy fast track'd in U.S. neurological form of Gaucher disease

The FDA has designated Fast Track review for Prevail Therapeutics (PRVL) PR001 for the treatment of neuronopathic Gaucher disease ((nGD)). The Company expects to initiate enrollment of the PROVIDE Phase 1/2 trial of PR001 for Type 2 neuronopathic Gaucher disease patients in sometime during this year.The FDA previously granted PR001 Rare Pediatric Disease tag for the treatment of nGD, and Orphan Drug for the treatment of patients with Gaucher disease. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.The Fast Track tag expedites/facilitates the review of product candidates, and allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s marketing application.Gaucher disease is an inherited disorder caused by the accumulation of a type of lipid in tissues due to the dysfunction in

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Prevail Therapeutics' gene therapy fast track'd in U.S. neurological form of Gaucher disease