ADMA Biologicals soars on FDA approval

The US Food and Drug Administration has approved ASCENIV, formerly referred to as RI-002, from US bio pharma company ADMA Biologics (Nasdaq: ADMA), whose shares leapt 54% in heavy pre-market trading on Tuesday,

ASCENIV is an intravenous immune globulin (IVIG) drug product for the treatment of primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents (12 to 17 years of age). The company anticipates having the product available for commercial launch during the second half of 2019.

The license covers the Boca Raton, Florida, manufacturing facility which has demonstrated compliance with FDA requirements as well as authorizes ADMA to manufacture and enter into interstate commerce with ASCENIV.