Precision BioSciences Gets FDAT Fast Track Status For PBGENE-DMD
(RTTNews) - Precision BioSciences said the U.S. Food and Drug Administration has granted Fast Track designation to its investigational therapy PBGENE-DMD for the treatment of Duchenne muscular dystrophy.
The company said the designation is intended to facilitate development and speed the review of therapies that address serious conditions with significant unmet medical needs.
"Fast Track designation is an important regulatory milestone for PBGENE-DMD and reflects the significant unmet need in DMD," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "We believe this designation, together with our recent IND clearance, supports PBGENE-DMD's continued momentum towards clinical investigation in boys living with DMD."
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