iECURE Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ECUR-506 for Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency
Precision BioSciences, Inc. (DTIL)
Last precision biosciences, inc. earnings: 11/12 07:15 am
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Source: Business Wire
Reached alignment with FDA on endpoints, comparators and sample size for the ongoing OTC-HOPE study which could support Biologics License Application (BLA)Awarded Innovation Passport under the United Kingdom’s relaunched Innovative Licensing and Access Pathway (ILAP) PHILADELPHIA--(BUSINESS WIRE)--iECURE, Inc., a genome editing company focused on the development of variant-agnostic in vivo targeted gene insertion therapies for the treatment of liver disorders with significant unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ECUR-506, the company’s investigational in vivo targeted gene insertion therapy for the treatment of neonatal onset ornithine transcarbamylase (OTC) deficiency. RMAT designation will provide the added benefit of intensive FDA guidance and expedited review throughout the program’s development.Separately, the company met and aligned with the FDA on the primary and
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Earnings
- 11/3/25 - Miss
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- 1/13/26 - Form 8-K
- 1/8/26 - Form EFFECT
- 12/30/25 - Form S-3
- DTIL's page on the SEC website