Puma Biotechnology (PBYI) Abstract Data Helps Explain Need to Change Trial - RBC
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RBC Capital analyst Simos Simeonidis weighed in on Sector Perform-rated Puma Biotechnology (NYSE: PBYI) amid SABCS loperamide prophylaxis data show a higher than expected Grade 3 diarrhea rate. He said the data helps eplains the need to try new regimen.
commented, ". In an abstract released this morning, Puma disclosed data from the Phase II CONTROL trial in the extended adjuvant setting showing that treatment with loperamide helps lower the ~40% Grade 3 (G3) diarrhea seen in the ExteNET Phase III trial. However, the numbers released today show that the G3 rates went up compared to what was disclosed last year (see table on page 2). Specifically, in patients in the original loperamide protocol, the rate of G3 diarrhea increased to 21.4% from 18.5%. Furthermore, in the amended protocol arm, the amount of G3 diarrhea more than doubled from 13% to 28.6%. Overall, the blended rate between these two arms was 27.1% vs. 16% last year."
He added, "The company had recently disclosed they had added a new arm to the study, combining the corticosteroid budesonide to help with the prophylaxis regimen. Today's release of the worsening (vs. last year's data) diarrhea, helps explain the need for this change in the trial. While we view the 12.5% rate of G3 diarrhea as potentially promising, we point to the small n (16 patients) and to the fact that these data are still early (i.e. it is possible that they actually get worse over time, just as the data from arms 1 and 2 did). The update in San Antonio should have slightly more mature data; however, we view the fact that loperamide alone no longer appears sufficient to prophylaxe against severe diarrhea as a significant negative for neratinib and the stock."
Shares of Puma Biotechnology closed at $50.40 yesterday.
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