Cerecor Inc. (NASDAQ: CERC) stock gains by 11.42% in the current market trading. Cerecor is a biopharmaceutical corporation dedicated to developing and commercializing drugs for genetic and orphan diseases. CERC is developing a portfolio of novel treatments to target unmet medical needs of rare and orphan disorders at the clinical level.
What is happening?
CERC-002 has been awarded Fast Track status by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized patients. CERC-002 is a truly human monoclonal antibody that targets LIGHT for the first time (tumor necrosis factor superfamily member 14, TNFSF14).
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Drugs that are being formulated for the treatment of dangerous or life-threatening disorders or illnesses with an unmet medical requirement are given Fast Track status. The provision’s goal is to speed up the production and approval of medications to cure dangerous or life-threatening disorders so that an approved medication can hit the market sooner. Drug sponsors that earn Fast Track status have the potential to meet with the FDA approval committee more often in the production process. A Biologic License Application (BLA) for CERC-002 that has been designated as Fast Track is suitable for both rolling submission and priority inspection.
About CERC-002
Kyowa Kirin has approved CERC-002 which is a totally human anti-LIGHT or tumor necrosis factor superfamily member 14 (TNFSF14) monoclonal antibody. It is the only anti-LIGHT treatment in clinical trials, and it has the ability to combat a variety of LIGHT-related immune diseases, including cytokine storm-induced COVID-19 ARDS. It’s now being tested for pediatric Crohn’s disease and COVID-19 ARDS caused by a cytokine storm. Cerecor has also collaborated with Myriad RBM to create a validated, high sensitivity serum/plasma-free LIGHT assay.