The FDA has accepted Shield Therapeutics‘ IND for a Phase III pivotal trial of ST10, Shield’s novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD). The company plans to initiate the study in the U.S. in 1H14; positive data would be the cornerstone of a subsequent NDA submission. The 16-week prospective, multicenter, randomized, double-blind, placebo-controlled study will enroll approximatel...