Precision BioSciences Receives U.S. FDA Fast Track Designation for PBGENE-HBV, a First-In-Class Gene Editing Therapy Designed to Eliminate the Root Cause of Chronic Hepatitis B
Precision BioSciences, Inc. (DTIL)
Last precision biosciences, inc. earnings: 11/12 07:15 am
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Source: Business Wire
DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PBGENE-HBV, the Company’s lead wholly owned in vivo gene editing program designed to cure chronic hepatitis B by eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in hepatocytes.“We are pleased to receive Fast Track designation from the FDA for PBGENE-HBV and believe this classification underscores the urgent need for improved treatment options for patients living with chronic hepatitis B,” said Michael Amoroso, President and Chief Executive Officer at Precision BioSciences. “We’ve been encouraged by the initial safety and antiviral activity we have observed in the ELIMINATE-B trial an
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- Precision BioSciences Announces Presentation of Clinical Data from the ELIMINATE-B Trial at HEP-DART 2025 [Yahoo! Finance]Yahoo! Finance
- Precision BioSciences Announces Presentation of Clinical Data from the ELIMINATE-B Trial at HEP-DART 2025Business Wire
- Precision BioSciences, Inc. (DTIL) Discusses ARCUS Platform Progress and ELIMINATE-B Clinical Trial Update for Chronic Hepatitis B Transcript [Seeking Alpha]Seeking Alpha
DTIL
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- 11/3/25 - Miss
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Sec Filings
- 11/14/25 - Form SCHEDULE
- 11/12/25 - Form 8-K
- 11/12/25 - Form 424B5
- DTIL's page on the SEC website