Medgenics (MDGN)

[mlkrborn]

Medgenics receives FDA clearance to commence Phase IIb trial of EPODURE for sustained anemia treatment in dialysis patients (MDGN) 5.65 +0.15 : The FDA cleared the Phase IIb study protocol based on results from the Company's prior Phase I/II anemia study of EPODURE in Israel, which reported safety and maintenance of hemoglobin for months from a single EPODURE treatment in pre-dialysis patients without requiring injections of EPO or ESAs, as well as on the complete preclinical package. The Company was particularly encouraged that clearance was received within the 30-day required regulatory response period from submission of the IND application and without major issues being raised. Medgenics views this as an early, second validation from an independent critical review in the U.S. of its Biopump platform.