Precision BioSciences Receives Pre-IND Feedback From FDA For PBGENE-HBV As It Advances Towards Clinical Readiness
Portfolio Pulse from Benzinga Newsdesk
Precision BioSciences has received positive pre-IND feedback from the FDA for its PBGENE-HBV program, supporting its clinical development path. The company is conducting IND/CTA enabling studies and plans to file for IND and/or CTA in 2024. PBGENE-HBV aims to be the first potentially curative gene editing program for eliminating cccDNA and inactivating integrated HBV DNA.
February 14, 2024 | 12:15 pm
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Precision BioSciences has received encouraging pre-IND feedback from the FDA for its PBGENE-HBV program, indicating a strong regulatory path forward. The company plans to file for IND and/or CTA in 2024, aiming to pioneer a potentially curative gene editing treatment for HBV.
The positive pre-IND feedback from the FDA is a significant milestone for Precision BioSciences, indicating regulatory support for the PBGENE-HBV program. This development enhances the company's credibility and potential market leadership in gene editing therapies for HBV, likely leading to increased investor confidence and a positive impact on the stock price in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100