On Jan. 11, 2021, Editas Medicine announced the FDA had cleared the initiation of the safety phase of the Companyﾒs EDIT-301 clinical trial, and the Company begin dosing patients. The Company was required to develop and submit to the FDA an improved potency assay prior to enrolling the efficacy phase of the RUBY trial.

EDIT-301 is an experimental, ex vivo gene editing cell medicine in development for the treatment of sickle cell disease. Previously, the Company received Rare Pediatric Disease designation from the FDA for EDIT-301. EDIT-301 is the first experimental medicine in development generated using CRISPR/Cas12a gene editing.