ADMA Biologics' Lead Product Candidate RI-002 Achieves Primary Endpoint

(RTTNews) - ADMA Biologics Inc. (ADMA) announced its lead product candidate RI-002 has demonstrated positive Phase III results and successfully achieved its primary endpoint. While final data from the study will be reported during the first quarter of 2015, preliminary analysis indicates that treatment with RI-002 resulted in no serious bacterial infections observed in study subjects during the trial. The company said this is well under the FDA requirement. Data on the secondary endpoints is expected to be provided during the first quarter of 2015.

The company is currently assembling its BLA for planned submission to FDA during the first half of 2015.