iECURE Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of ECUR-506 Ahead of Planned BLA Submission
Precision BioSciences, Inc. (DTIL)
Last precision biosciences, inc. earnings: 11/12 07:15 am
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Source: Business Wire
FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports manufacturing readiness for therapies with expedited clinical development timelinesECUR-506 selected as one of up to nine programs annuallyParticipation enables additional FDA engagement on CMC strategy ahead of a potential BLA submission PHILADELPHIA--(BUSINESS WIRE)--iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo targeted gene insertion therapies for the treatment of severe, inherited, neurometabolic disorders, today announced that the U.S. Food and Drug Administration (FDA) has selected ECUR-506, the company’s investigational in vivo targeted gene insertion therapy for neonatal-onset ornithine transcarbamylase (OTC) deficiency, to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. iECURE was invited by the FDA to participate in the CDRP program, which selects up to nine dev
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DTIL
Earnings
- 3/12/26 - Beat
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Sec Filings
- 3/17/26 - Form 8-K
- 3/12/26 - Form 10-K
- 3/12/26 - Form 8-K
- DTIL's page on the SEC website