Precision BioSciences, Inc. (DTIL) said its partner iECURE has received Fast Track designation from the FDA for ECUR-506. ECUR-506 is iECURE's in vivo gene insertion program designed to treat neonatal onset Ornithine Transcarbamylase deficiency utilizing a PCSK9-specific ARCUS nuclease, licensed from Precision, that enables insertion of a functional copy of the OTC gene.
ECUR-506 previously received Rare Pediatric Disease and Orphan Drug designations from the FDA, and Orphan designation from the European Commission for the treatment of OTC
deficiency.
Shares of Precision BioSciences are up 8% at $11.60 in pre-market trade on Tuesday.
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