Key Takeaway: Precision BioSciences has received pre-IND feedback from the U.S. FDA for its PBGENE-HBV program, indicating alignment with regulatory expectations. The company is currently conducting IND/CTA enabling studies and expects to file for IND and/or CTA in 2024. This program aims to be the first and only of its kind.
Price reaction · baseline $11.172 (2024-02-13 close) · hit pre-market · 1 other DTIL headline(s) in the window, move may be shared
day 0 close
+7.3%
day 1
+3.8%
day 3 · peak
+15.9%
Market Sentiment Analysis
POSITIVE FACTORS
Regulatory feedback supports clinical development path.
Final clinical candidate for PBGENE-HBV is underway.
IND/CTA filing expected in 2024.
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
– Regulatory feedback and alignment from both U.S. and ex- U.S. regulators supports clinical development path for PBGENE-HBV – IND/CTA enabling studies with final clinical candidate underway for PBGENE-HBV program; expect to file IND and/or CTA in 2024 – Expected to be the first and only
Frequently Asked Questions
What feedback did Precision BioSciences receive from the FDA?
The FDA provided pre-IND feedback that supports the clinical development path for PBGENE-HBV.
When does Precision BioSciences expect to file for IND?
The company expects to file for IND and/or CTA in 2024.
What is the status of the PBGENE-HBV program?
Final clinical candidate studies for the PBGENE-HBV program are currently underway.
What is unique about PBGENE-HBV?
PBGENE-HBV is expected to be the first and only of its kind in its therapeutic area.