iECURE Receives FDA Fast Track Designation for ECUR-506 for the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency [Yahoo! Finance]
Precision BioSciences, Inc. (DTIL)
Last precision biosciences, inc. earnings: 11/12 07:15 am
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Source: Yahoo! Finance
therapies for the treatment of liver disorders with significant unmet need, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ECUR-506, the company's in vivo gene insertion program designed to treat neonatal onset Ornithine Transcarbamylase (OTC) deficiency. The Fast Track designation is designed to facilitate the development and expedite the review of therapeutics to treat serious conditions that fill an unmet medical need. Therapeutics that receive Fast Track designation are eligible for more frequent meetings with and written communication from FDA to discuss the therapeutic's development plan and ensure collection of appropriate data to support potential approval of the therapeutic. Provided relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review as well. "Receipt of Fast Track designation from the FDA is a validation of the severe unmet need for pat
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- Precision BioSciences Reports First Quarter 2024 Financial Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
- Precision BioSciences Reports First Quarter 2024 Financial Results and Provides Business UpdateBusiness Wire
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Earnings
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- 5/13/24 - Form 10-Q
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- 5/8/24 - Form 4
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