Stifel Upgrades Puma Biotechnology (PBYI) to Buy After Neratinib NDA Accepted
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Stifel upgraded Puma Biotechnology (NYSE: PBYI) from Hold to Buy with a price target of $88.00 (from $61.00) after the FDA accepted for review the neratinib New Drug Application in the extended adjuvant treatment, which significantly de-risks the story.
Analyst Thomas Shrader commented, "Puma today announced that the FDA has accepted for review the neratinib New Drug Application in the extended adjuvant treatment. For some time, we have viewed this event as unusually important for this drug due the procedural irregularities in the ExteNet trial that might have caused it to no longer be considered as “registrational”. However, investors appear to have been less cautious and the stock has run up considerably prior to today’s news to levels, which we believe reflect a reasonable commercial scenario for neratinib. We expect an ODAC panel for neratinib in the extended adjuvant setting as there are no other drugs approved in this setting for Her2 amplified disease. We expect some discussion of the possibility of waiting for OS data before approval, but overall we believe physicians are warming to this drug whose efficacy matches the greatest area of unmet need (HR+ patients) with a safety profile that increasingly looks to be under reasonable control. Based on today’s news, we are raising our probability of approval from 75% to 90%. As a result we raise our price target from $61 to $88 and raise our rating from Hold to Buy."
Shares of Puma Biotechnology closed at $58.95 yesterday.
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