Prevail’s Gene Therapy Candidate PR001 Granted FDA Fast Track Status

Prevail’s Gene Therapy Candidate PR001 Granted FDA Fast Track Status
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Prevail Therapeutics’ lead gene therapy candidate, PR001, for the treatment of people with Parkinson’s disease associated with GBA1 gene mutations. Fast Track status will support and expedite the clinical development, regulatory review, and potential marketing approval of PR001. The FDA’s decision follows its acceptance of Prevail’s Investigational New ... read more
Source: Parkinson’s News TodayPublished on 2019-07-10By Alice Melão