The U.S. Food and Drug Administration granted fast-track designation to Cerecor Inc.'s medicine CERC-802 to treat an ultrarare inherited metabolic disorder.
The Rockville, Md.-based pharmaceutical company's shares shot up 10.70% to $4.24 in premarket trading on Aug. 21 on the Nasdaq. The stock price had settled at $3.97 as of 9:39 a.m. ET, up 3.7%.
Cerecor is evaluating CERC-802 to treat Mannose-Phosphate Isomerase Deficiency, also known as MPI-CDG or CDG-1b.
MPI-CDG is a rare metabolic disorder in infants caused by deficient activity of the enzyme mannose phosphate isomerase. Symptoms include chronic diarrhea, failure to thrive, liver fibrosis and gastrointestinal complications.
Cerecor's Executive Chairman Simon Pedder said in an Aug. 21 press release that the company will continue to work closely with the FDA to advance the development program. The company is collecting data through a clinical trial called CDG First to support a new drug application for the rare disorder, the executive said.
Cerecor's other therapy, CERC-801, has also received FDA fast-track status to treat a rare inherited metabolic disorder called phosphoglucomutase 1 deficiency.
Fast-track designation speeds the development and expedited review of drugs for treating serious or life-threatening diseases or conditions.
