- 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.
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Posted In: BiotechNewsPenny StocksFDAGeneralImmunodeficiencyLeukocyte Adhesion DeficiencyOrphan Drug Designation
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