ADMA Biologics (ADMA)

ADMA Biologics is an advanced clinical stage biopharmaceutical company focusing on the development of plasma based biologics as a potential treatment for respiratory syncytial virus (RSV) infection in patients suffering from primary immune deficiency disease (PIDD) and also affords benefit for RSV infection management in patients undergoing stem cell and solid organ transplantation.

The company is conducting a Phase III study for potential approval of their lead product, RI-002 as an intravenous immune globulin (IVIG). Given the ongoing pivotal Phase III study design is based on a well-established IVIG clinical development guidance issued by the FDA, and the fact that multiple IVIG products have been successfully developed; we view the hurdle for achieving a positive Phase III study outcome leading to a potential approval is relatively modest.

In addition to the development of RI-002, ADMA Biologics also participated in operating plasma collection centers as second value driver for ADMA shareholders.  The company currently operates one plasma collection center and plans to build and operate two more plasma collection centers over the next few years.

Published Reports

ADMA-2018-12-20-CRL for PAS drug substance
ADMA-2018-11-09-3Q18
ADMA-2018-10-17-RI-002 PDUFA date on 4-2-2019
ADMA-2018-10-01-RI-002 BLA refiled
ADMA-2018-09-24-RI-002 BLA refiling shortly
ADMA-2018-09-05-RI-002 BLA refiling
ADMA-2018-08-13-2Q18
ADMA-2018-07-27-FDA compliance inspection close-out
ADMA-2018-05-15-1Q18
ADMA-2018-03-05-4Q17
ADMA-2017-08-14-2Q17 rev
ADMA-2017-06-27-Corporate update rev
ADMA-2017-05-16-1Q17 final (2)
ADMA-2017-02-27-4Q16 rev2
ADMA-2017-01-23-Acquired Biotest assets
adma-2016-11-11-3q16-rev
ADMA-2016-05-16-1Q16 rev
ADMA-2016-03-24-4Q15 re
ADMA-2015-11-05-IPI congress presentationv
ADMA-2015-11-11-3Q15 rev
ADMA-2015-06-30-Patent allowance issued
ADMA-2015-09-17-2nd center approved
ADMA-2015-09-21-BLA accepted rev
ADMA-2-15-08-12-2Q15 rev
ADMA-2015-07-31-BLA filed rev2
ADMA-2015-06-01-Mgnt update rev
ADMA-2015-05-13-1Q15 rev
ADMA-2015-03-10-4Q14
ADMA-2015-02-23-Compelling 2nd endpont results rev
ADMA-2014-12-03-P3 positive rev
ADMA-2014-11-18-TP to $18 rev2
ADMA-2014-11-10-3Q14 rev (2)
ADMA-2014-11-06-Nasdaq listing rev
ADMA-2014-08-12-2Q14 REVISED rev
ADMA-2014-05-14-1Q14 rev
ADMA-2014-03-31-4Q13
ADMA-2014-01-27-Mgnt Update
ADMA-initiation-2013-11-21-L-Final rev