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1

iECURE Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ECUR-506 for Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

January 7, 2026/in news, press release/by David Anderson

January 7, 2026

2

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

March 17, 2026/in news, press release/by eallison

March 18, 2026

3

Robert Pietrusko, Pharm.D.

August 27, 2025/in Advisors, Team/by eallison

Regulatory Affairs Advisor

4

Tay Salimullah

August 27, 2025/in Advisors, Team/by eallison

Commercial Advisor

5

iECURE Receives FDA Fast Track Designation for ECUR-506 for the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

May 7, 2024/in news, press release/by David Anderson

May 7, 2024

6

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.

April 4, 2024/in news, press release/by David Anderson

April 4, 2024

7

iECURE Secures Approval from U.K. Medicines & Healthcare Products Regulatory Agency to Expand the OTC-HOPE Study of ECUR-506

March 5, 2024/in news, press release/by David Anderson

March 6, 2024

8

iECURE Secures Clearance from Australian Therapeutic Goods Administration for its Clinical Trial Approval for the OTC-HOPE Phase 1/2 Study of ECUR-506

December 12, 2023/in news, press release/by eallison

December 13, 2023

9

iECURE Appoints George Diaz, M.D., Ph.D., as VP, Therapeutic Area Lead for Urea Cycle Disorders

April 25, 2022/in news, press release/by David Anderson

April 25, 2022

10

iECURE Expands Leadership Team with the Appointment of Mark Semanick as VP and Head of Technical Operations and Brad Dickerson as VP of Project Management & Patient Advocacy

February 1, 2022/in news, press release/by David Anderson

February 1, 2022