iECURE Secures Approval from U.K. Medicines & Healthcare Products Regulatory Agency to Expand the OTC-HOPE Study of ECUR-506
Precision BioSciences, Inc. (DTIL)
Last precision biosciences, inc. earnings: 11/12 07:15 am
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Source: Business Wire
ECUR-506 is an investigational gene editing-based therapy for the treatment of Ornithine Transcarbamylase (OTC) deficiency PHILADELPHIA--(BUSINESS WIRE)--iECURE, Inc., a gene editing company focused on the development of mutation-agnostic in vivo gene insertion, or knock-in, editing therapies for the treatment of liver disorders with significant unmet need, announced today approval from the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) of the company’s Clinical Trial Authorisation application (CTA) to expand the OTC-HOPE study into the U.K. The OTC-HOPE study is investigating ECUR-506, an investigational gene editing-based therapy, for the treatment of Ornithine Transcarbamylase (OTC) deficiency in infants. The CTA approval by the MHRA follows the previous approval to begin the OTC-HOPE study by the Australian Therapeutic Goods Administration (TGA).“ECUR-506 is the first ever clinical meganuclease-based in vivo gene insertion program, and as we continue progressing
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- Precision BioSciences (DTIL) Now Trades Above Golden Cross: Time to Buy? [Yahoo! Finance]Yahoo! Finance
- iECURE Announces FDA Clearance of Investigational New Drug Application for ECUR-506 to Initiate OTC-HOPE Trial for Treatment of Neonatal Onset Ornithine Transcarbamylase Deficiency in the U.S. [Yahoo! Finance]Yahoo! Finance
- iECURE Announces FDA Clearance of Investigational New Drug Application for ECUR-506 to Initiate OTC-HOPE Trial for Treatment of Neonatal Onset Ornithine Transcarbamylase Deficiency in the U.S.Business Wire
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