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Cardiome not quite there on resubmission of Brinavess NDA; shares down 5% premarket

Published 08/21/2017, 09:12 AM
© Reuters.  Cardiome not quite there on resubmission of Brinavess NDA; shares down 5% premarket
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  • Thinly traded micro cap Cardiome (NASDAQ:CRME) is down 5% premarket on light volume in response to its announcement that the FDA has informed it that its proposed data package is not sufficient to support a resubmission of the BRINAVESS (vernakalant hydrochloride IV) New Drug Application (NDA) for the treatment of atrial fibrillation.
  • The company wanted to refile the NDA using the original dataset, six years of real-world safety data based on sales of BRINAVESS in 33 countries, interim data from the SPECTRUM study and preclinical data from studies performed at the agency's request.
  • It says it will continue working with the FDA as it considers its regulatory options.
  • Previously: Cardiome cleared to commercialize Brinavess in Canada; shares ahead 2% (March 14)
  • Now read: Endo International plc 2017 Q2 - Results - Earnings Call Slides


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