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FDA accepts ADMA Bio's Bivigam application amendment, action date October 25; shares up 18%

Jul. 26, 2018 10:08 AM ETADMA Biologics, Inc. (ADMA) StockBy: Douglas W. House, SA News Editor
  • 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)

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