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Precision Says its Investigational New Drug Application for Hepatitis B Treatment Gets US FDA's Clearance
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Precision Says its Investigational New Drug Application for Hepatitis B Treatment Gets US FDA's Clearance
Mar 17, 2025 5:43 AM

08:22 AM EDT, 03/17/2025 (MT Newswires) -- Precision BioSciences ( DTIL ) said Monday its investigational new drug application for PBGENE-HBV in vivo gene editing program has received the US Food and Drug Administration's clearance to treat chronic hepatitis B.

The company is in final stages of US site activation to start enrolling participants in its Eliminate-B study in the country and will soon initiate phase 1 clinical activities at the Liver Center at Massachusetts General Hospital, Precision added.

The trial is already enrolling patients in Moldova, Hong Kong, and New Zealand, the company said, adding that it intends to expand the trial in the UK.

Shares of the company were up more than 7% in recent Monday premarket activity.

Price: 5.40, Change: +0.36, Percent Change: +7.14

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