Precision BioSciences Announces Clearance of Investigational New Drug Application by the U.S. FDA for First-in-Class PBGENE-HBV Designed to Eliminate Root Cause of Chronic Hepatitis B
Monday, March 17, 2025 BiopharmaWatch Research 1 min read
Key Takeaway: Precision BioSciences has received clearance from the U.S. FDA for its investigational gene editing therapy, PBGENE-HBV, aimed at treating chronic hepatitis B. This marks a significant regulatory achievement as it is the first in vivo gene editing therapy to enter clinical trials for this condition. The company plans to expand its Phase 1 clinical trials following this clearance.
Price reaction · baseline $5.04 (2025-03-14 close) · hit pre-market · 2 other DTIL headline(s) in the window, move may be shared
day 0 close
+0.2%
day 1
-1.2%
day 3
+6.3%
Market Sentiment Analysis
POSITIVE FACTORS
First-ever investigational gene editing therapy for hepatitis B.
IND clearance marks a significant regulatory milestone.
Company is expanding its Phase 1 clinical trials.
BiopharmaWatch Analysis
From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+24%
120-day peak, hindsight
Typical move
4.8%
average across 2 past catalysts
Cash runway
~19 mo
Low dilution risk
Lead asset
Targeted CEA CAR-T
Phase 1 · Advanced Lung Cancer
Full Press Release Details
– PBGENE-HBV is the first-ever investigational in vivo gene editing therapy cleared to enter clinical trials for the treatment of chronic hepatitis B in the United States ( U.S. ) – – IND clearance represents a significant regulatory milestone for PBGENE-HBV – – Company to expand its Phase 1
Frequently Asked Questions
What is PBGENE-HBV?
PBGENE-HBV is an investigational in vivo gene editing therapy for chronic hepatitis B.
What milestone did Precision BioSciences achieve?
The company received FDA clearance for PBGENE-HBV to enter clinical trials.
What phase is Precision BioSciences expanding?
The company is expanding its Phase 1 clinical trials for PBGENE-HBV.
Is PBGENE-HBV the first of its kind?
Yes, it is the first-ever gene editing therapy cleared for chronic hepatitis B.