Momenta Pharmaceuticals (NASDAQ:MNTA) is up 3% premarket on light volume following its announcement that the FDA has designated lead candidate M281 for Fast Track review for the treatment of hemolytic disease of the fetus and newborn, a serious rare blood disorder that occurs when the red blood cells are incompatible between a mother and baby caused by the transfer of alloantibodies from the mother to the fetus during pregnancy.
Phase 2-stage M281 (nipocalimab) is a fully human monoclonal antibody designed to reduce the risk of fetal anemia by inducing the clearance of pathogenic IgG antibodies in the mother’s circulation by blocking a protein called the neonatal Fc receptor (FcRn) that plays a key role in IgG recycling.
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