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Briefing docs out for Ad Comm review of Puma's neratinib; shares up 52%

Published 05/22/2017, 10:23 AM
© Reuters.  Briefing docs out for Ad Comm review of Puma's neratinib; shares up 52%
PBYI
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  • Puma Biotechnology (PBYI +51.5%) rockets on average volume after the release of the briefing materials for Wednesday's FDA advisory committee review of its New Drug Application (NDA) seeking approval of neratinib, branded as NERLYNX, for extended adjuvant treatment of patients with HER2+ breast cancer who have been previously treated with Roche's Herceptin (trastuzumab).
  • Longs are apparently giddy over the positive implications of the third bullet under Topics of Discussion: "The totality of evidence of neratinib's efficacy data in the context of other approvals in the adjuvant setting." The data show a similar rate of benefit, measured by disease-free survival, when compared to approvals of adjuvant hormonal therapies, but "with a different toxicity profile."
  • FDA briefing doc
  • Errata to FDA briefing doc
  • Puma briefing doc
  • Now read: Amicus Therapeutics (FOLD) Investor Presentation - Slideshow


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