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Wednesday, August 21, 2019

Cerecor’s CERC-802 Fast Track’d for rare metabolic disorder

The FDA grants Fast Track status for Cerecor’s (NASDAQ:CERC) CERC-802 for the treatment of a rare inherited inborn error of metabolism called Mannose-Phosphate Isomerase Deficiency (MPI-CDG).
CERC-802 is a ultra-pure oral formulation of a naturally occurring simple sugar (monosaccharide) called D-mannose. Dietary monosaccharide formulations have shown to lessen the clinical symptoms of the disorder.
MPI-CDG is characterized by the inability to metabolize glycoprotein which results in high infant morbidity and mortality.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Update: Shares are up 16% premarket on light volume.

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