FDA Clears Precision’s IND for PBGENE-DMD - BioTuesdays

FDA clears Precision’s IND for PBGENE-DMD - BioTuesdays

Precision BioSciences (NASDAQ: DTIL) has announced that the FDA has granted a Study May Proceed notification, allowing initiation of clinical trial site activation for the Phase 1/2 FUNCTION-DMD trial of PBGENE-DMD in ambulatory Duchenne muscular dystrophy (DMD) patients at specialized clinical sites. The objective of the study is to evaluate safety, tolerability and efficacy, including dystrophin protein expression and functional outcomes in pa…

Trial testing gene-editing therapy for DMD gets FDA green light

The U.S. Food and Drug Administration (FDA) has cleared Precision Biosciences to launch a clinical trial testing its gene-editing therapy candidate PBGENE-DMD in people with Duchenne muscular dystrophy (DMD) caused by certain mutations. Precision announced it had received a “Study May Proceed notification” from the U.S. regulatory agency that will allow clinical testing of the therapy’s safety, tolerability, and effectiveness. “We’re excited to …