Precision BioSciences (DTIL) said Tuesday the US Food and Drug Administration granted Fast Track designation for PBGENE-HBV
gene editing therapy to cure chronic hepatitis B infection.
Precision said it is evaluating PBGENE-HBV in a global phase 1 trial, with data expected throughout 2025.
A drug granted the designation may be eligible for more frequent meetings with the FDA and rolling review for marketing approval, according to the company.
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