Precision BioSciences Receives First Approval of Clinical Trial Application to Initiate PBGENE-HBV First-In-Human Study for the Treatment of Chronic Hepatitis B
Friday, November 22, 2024 BiopharmaWatch Research 1 min read
Key Takeaway: Precision BioSciences has received its first approval for a clinical trial application for PBGENE-HBV in Moldova, marking a significant step for its in vivo gene editing program targeting chronic hepatitis B. Additional regulatory applications are still pending. The company will also host an investor event to highlight the safety of its clinical candidate.
Price reaction · baseline $6.5 (2024-11-21 close) · hit pre-market · 6 other DTIL headline(s) in the window, move may be shared
day 0 close · peak
+11.7%
day 1
+11.4%
day 3
+9.4%
Market Sentiment Analysis
POSITIVE FACTORS
First approval for clinical trial application received in Moldova.
PBGENE-HBV is pioneering in vivo gene editing for chronic hepatitis B.
Company plans to host an investor event to discuss safety.
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
– Clinical Trial Application accepted in Moldova with additional regulatory applications pending approval – PBGENE-HBV is the first in vivo gene editing program for chronic hepatitis B virus to move into global clinical trials – Company to host investor event highlighting clinical candidate safety
Frequently Asked Questions
What is PBGENE-HBV?
PBGENE-HBV is the first in vivo gene editing program targeting chronic hepatitis B.
Where was the clinical trial application approved?
The clinical trial application was approved in Moldova.
What will Precision BioSciences highlight at the investor event?
The company will highlight the safety of its clinical candidate at the investor event.
Are there other regulatory applications pending?
Yes, additional regulatory applications are pending approval.