Lead Product Candidate
Specialty High-Titer Immune Globulin
Our lead product candidate (RI-002) targets the unmet needs of immune deficient patients, of which, a Biologics License Application (BLA) was submitted to the FDA in July 2015, which was accepted by the FDA on September 18, 2015. RI-002 demonstrated positive Phase III results and successfully achieved its primary endpoint of preventing serious bacterial infections such as bacterial pneumonia, osteomyelitis and bacterial sepsis in immune compromised Primary Immunodeficiency Diseases (PIDD) patients.
ADMA Biologics is a late stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases. Our targeted patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disorder or who may be immune-suppressed for medical reasons. Our product candidates are intended to be used by physician specialists focused on caring for immune-compromised patients with infectious diseases.
ADMA also operates two, FDA-licensed, GHA, MFDS-certified source plasma collection facilities, at our ADMA BioCenters located in Georgia, which provide a portion of blood plasma for the manufacturing of our lead product candidate RI-002.
FDA Approved Plasma Procurement
Plasma Collection Center
Our FDA-licensed, GHA, MFDS-certified source plasma collection facilities provide safe, self-sourced raw material plasma for our lead product candidate as well as serve the needs of our customers with a reliable supply of source plasma. Click here for more information. Learn how to become a life-saving plasma donor today!
- Aug 12, 2016 ADMA Biologics Reports Second Quarter 2016 Results
- Jul 29, 2016 ADMA Biologics Receives Complete Response Letter from FDA for Pending Biologics License Application
- Jun 16, 2016 ADMA Biologics to Present at the 2016 JMP Securities Life Sciences Conference
- May 13, 2016 ADMA Biologics Reports First Quarter 2016 Results