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Stock impact report

FDA Grants Cerecor’s Three Substrate Replacement Therapies Orphan Drug Designation

Cerecor, Inc (CERC) 
Last cerecor, inc earnings: 11/14 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: ir.cerecor.com
Company Research Source: GlobeNewswire
BALTIMORE, Jan. 16, 2019 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of therapies for rare and orphan diseases in pediatrics and neurology, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designations (ODD) to Cerecor’s three substrate replacement therapies for Congenital Disorders of Glycosylation (CDGs). The FDA granted ODD to:  CERC-801, D-galactose for the treatment of Phosphoglucomutase 1 (PGM1) Deficiency; CERC-802, D-mannose for the treatment of Mannose Phosphate Isomerase (MPI) Deficiency; and CERC-803, L-fucose for the treatment of Congenital Disorder of Glycosylation IIc (CDG-IIc). Each indication is an ultra-rare CDG estimated to have fewer than 1,000 patients in the United States. All three programs have previously been granted Rare Pediatric Disease Designation (RPDD) by the FDA. Cerecor completed pre-IND meetings with the FDA and see Show less Read more
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