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Home » FDA adcom gears up for Puma, Emmaus votes
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FDA adcom gears up for Puma, Emmaus votes

May 23, 2017
By Michael Fitzhugh
FDA briefing documents framing a Wednesday Oncologic Drugs Advisory Committee (ODAC) review of Puma Biotechnology Inc.'s lead candidate, neratinib, highlight tolerability and trial amendment issues, but still appear supportive of the drug's efficacy as an extended adjuvant treatment for HER2-positive early stage breast cancer, analysts said. The news sent Los Angeles-based Puma's shares (NASDAQ:PBYI) up 39.2 percent in heavy trading Monday, to close at $52.60.
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