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 ...
Precision BioSciences, Inc. (DTIL)
Last precision biosciences, inc. earnings: 11/12 07:15 am
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Source: Yahoo! Finance
ECUR-506 is the first in vivo gene insertion program authorized for clinical investigation in infants in the U.S. 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 clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for ECUR-506 in Ornithine Transcarbamylase (OTC) deficiency. ECUR-506 will be evaluated in the OTC-HOPE study in newborn males with genetically confirmed neonatal onset OTC deficiency. The OTC-HOPE study was previously cleared to begin in the United Kingdom by the Medicines & Healthcare Products Regulatory Agency (MHRA) and Australia by the Therapeutic Goods Administration (TGA). "With this IND clearance, we are now activating sites in three countries in distinct geographical areas – United States, United Kingdom and Australia
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News
- Precision BioSciences Announces Return of Programs and Conclusion of Collaboration with Prevail Therapeutics [Yahoo! Finance]Yahoo! Finance
- Precision BioSciences Announces Return of Programs and Conclusion of Collaboration with Prevail TherapeuticsBusiness Wire
- 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.Business Wire
- Wall Street Analysts Predict a 407.94% Upside in Precision BioSciences (DTIL): Here's What You Should Know [Yahoo! Finance]Yahoo! Finance
DTIL
Earnings
- 3/27/24 - Miss
DTIL
Sec Filings
- 4/25/24 - Form ARS
- 4/25/24 - Form DEFA14A
- 4/25/24 - Form DEF
- DTIL's page on the SEC website