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EMA's oncology advisory group to render opinion on Puma Bio's neratinib next month; shares slip 2% after hours

Published 12/13/2017, 04:49 PM
© Reuters.  EMA's oncology advisory group to render opinion on Puma Bio's neratinib next month; shares slip 2% after hours
  • Puma Biotechnology (NYSE:PBYI) eases 2% after hours on light volume in response to its announcement that the European Medicines Agency (EMA) has asked the Scientific Advisory Group on Oncology to provide an opinion on the clinical data supporting the company's marketing application seeking approval for neratinib for the extended adjuvant treatment of early-stage HER2-positive breast cancer in patients previously treated with a regimen containing Roche's Herceptin (trastuzumab). The group will meet on January 11, 2018.
  • The EMA accepted the application for review on August 22. The company says it will respond to the Day-180 List of Outstanding Issues by December 22.
  • The normal EMA review period is 210 days so an opinion by the Committee for Medicinal Products for Human Use (CHMP) should be issued on or about March 20, 2018.
  • Now read: Don't Buy LendingClub - Cramer's Lightning Round (12/12/17)


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