Benzinga | Feb 2, 2021 09:14AM EST

Cerecor's CERC-803 Nabs US Orphan Drug Tag In Rare Immunodeficiency Disorder

* The FDA has designated Fast Track status to Cerecor Inc's (NASDAQ: CERC) CERC-803 for the treatment of Leukocyte Adhesion Deficiency Type 2 (LAD-II), a rare congenital disorder due to mutations in the SLC35C1 gene, and characterized by frequent infections, persistent leukocytosis (abnormally high level of white blood cells), and mental & growth retardation.

* Fast Track tag provides more frequent interaction with the FDA and a rolling review of the marketing application.

* The company expects to initiate a pivotal trial of CERC-803 in LAD-II in the first half of 2021, with topline data anticipated in the second half of 2021.

* Price Action: CERC is higher by 1.27% at $3.19 in the pre-market session on the last check Tuesday.