ADMA Biologics, Inc. (ADMA) announced positive top-line results from a phase III study on its lead candidate, RI-002. The company is evaluating RI-002 for the treatment of patients suffering from primary immune deficiency disease (PIDD).
RI-002, which is a specialty plasma-derived, polyclonal, intravenous immune globulin (IGIV), met the primary endpoint of the phase III study – prevention of serious bacterial infections (SBI) in immune-compromised PIDD patients.
Preliminary results from the study showed that PIDD patients when treated with RI-002 suffered from no SBIs such as bacterial pneumonia, osteomyelitis and bacterial sepsis over a period of 12 months. Moreover, results were well under the FDA requirement of ≤1 SBI per patient-year. The candidate was also found to be well-tolerated with no adverse events being reported during the course of the study.
ADMA Biologics intends to present the full data from the study in the first quarter of 2015. Additionally, the company plans to file a Biologics License Application (BLA) with the FDA for RI-002 for the treatment of patients with primary humoral immune deficiency in the first half of 2015.
We are pleased with the encouraging results from the phase III study. As RI-002 is the lead candidate in ADMA Biologics’ pipeline, we expect investor focus to remain on updates pertaining to its development.
ADMA Biologics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN), ANI Pharmaceuticals, Inc. (ANIP) and Biogen Idec Inc. (BIIB). All three carry a Zacks Rank #1 (Strong Buy).
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