Investing.com -- Shares of Precision BioSciences, Inc. (NASDAQ:DTIL) climbed 9% as the company received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its gene editing therapy, PBGENE-HBV, aimed at treating chronic hepatitis B.
The Fast Track designation is a significant regulatory milestone for Precision BioSciences, highlighting the urgent need for new treatments for chronic hepatitis B, a condition affecting an estimated 300 million people globally. The designation is intended to speed up the development and review process for drugs that address serious or life-threatening conditions and fill an unmet medical need.
According to Michael Amoroso, President and CEO of Precision BioSciences, the FDA’s recognition through the Fast Track designation underscores the potential of PBGENE-HBV to improve treatment options for patients with chronic hepatitis B. The company’s optimism is supported by initial safety and antiviral activity observed in the ELIMINATE-B trial. Precision BioSciences is conducting this global Phase 1 trial across multiple countries, including the United States, Moldova, Hong Kong, New Zealand, and the United Kingdom.
The therapy, PBGENE-HBV, is a first-of-its-kind in vivo gene editing program designed to potentially cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes. The company anticipates providing updates on the full low-dose cohort and data from higher dose levels throughout 2025.
Fast Track designation allows for more frequent communication and meetings with the FDA and enables a rolling review of the marketing approval application. Additionally, drugs with this designation may qualify for Priority Review if they meet certain criteria.
Precision BioSciences’ collaboration with Acuitas Therapeutics Inc. has provided lipid nanoparticle technology for PBGENE-HBV, further supporting the development of this potentially curative treatment. The market’s positive response to the Fast Track designation reflects investor optimism regarding the expedited development pathway and the potential impact of PBGENE-HBV on chronic hepatitis B treatment.
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