- Thinly traded micro cap ADMA Biologics (NASDAQ:ADMA +17.6%) is up almost double normal volume on the heels of its announcement that the FDA has accepted for review its BLA amendment seeking approval to relaunch BIVIGAM (intravenous immune globulin [human], 10%). The agency's action date is October 25.
- If all goes well, it will reintroduce the product in Q1 2019.
- The company acquired BIVIGAM from Biotest Pharmaceuticals in June 2017. Production was shut down to allow time to upgrade and renovate the production facility subsequent to a July 2016 Warning Letter from the FDA.
- Previously: ADMA Bio set for growth after acquisition of Biotest assets, relaunch of Bivigam imminent; shares ahead 14% (June 27, 2017)