Puma's (PBYI) Neratinib MAA is Likely in 1H16 - Stifel

Stifel analyst, Thomas Shrader, published an update on Puma Biotechnology (NYSE: PBYI) highlighting positive information from a from a company update call but not changing his Neutral rating. Notes follow:

Puma held a conference call to discuss its recent discussions with the EMA. Based on Positive feedback, the company expects to file an MAA based on the ExteNET 2 year PFS data in the extended adjuvant setting in 1H16. The company seemed to hint that the loperamide prophylaxis data from the ongoing Phase II trial are good and were received positively by the EMA.

A significant factor in the widespread use of neratinib in the extended adjuvant setting (after a year of Herceptin) has been the incidence of grade 3 diarrhea. Puma has an ongoing trial using high-dose loperamide to try to stop this issue and indicated on the call that interim data from 50-60 patients had been shared with the EMA. These data reflecting 2-8 months of loperamide use are probably pretty definitive as most of the grade 3 diarrhea is seen in the first two months or neratinib treatment. The fact that Puma volunteered these data to the agency in a meeting designed to get an OK for an MAA submission seems, to us, to suggest that these data are good.

One of the most interesting aspects of the call was the lack of discussion between the EMA and Puma management of the relative hazard ratios of patients taking neratinib that were HR+ versus those that were HR-. We assume the EMA was aware that essentially all the benefit of the drug was seen in the HR+ patients.

For an analyst ratings summary and ratings history on Puma Biotechnology click here. For more ratings news on Puma Biotechnology click here.

Shares of Puma Biotechnology closed at $75.30 yesterday.

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