The trial has received Human Research Ethics Committee (HREC) approval and completed the Clinical Trial Notification (CTN) process with Australia’s Therapeutic Goods Administration (TGA) and has also been submitted for review in New Zealand. If approved in New Zealand, patients in both countries will be eligible to enroll in the Strive trial. The Company also announced that new preclinical data, demonstrating durability of LDL-C reduction with EDIT-401, will be released via an oral presentation at the American Heart Association (AHA) Scientific Sessions 2026, taking place November 6-9, 2026, in Chicago, Illinois.

EDIT-401 is an experimental, potentially best-in-class in vivo gene editing medicine for the treatment of hyperlipidemia. Utilizing Editas’ differentiated upregulation approach, EDIT-401 is designed to directly edit the LDLR gene to increase LDLR protein expression and reduce LDL-cholesterol (LDL-C) levels. In preclinical studies, EDIT-401 demonstrated ~90 percent or greater mean reduction in multiple atherogenic lipoproteins, including LDL-C, Lp(a), and ApoB in non-human primates. New preclinical data to be presented at AHA also demonstrated an LDL-C reduction of ~90 percent was maintained over 10 months in an ongoing study in non-human primates.