Analysts Weigh In On Puma Biotechnology Following Data Release

By Shira Gonen

Top Analyst Eric Schmidt of Cowen and Co. recently weighed in on Puma Biotechnology Inc PBYI after the company released Phase 2 data on the use of loperamide prophylaxis to treat diarrhea in breast cancer patients taking its treatment neratinib.

The data indicated that loperamide significantly reduced different grades of diarrhea. Of the patients enrolled in the study, only 43% experienced any grade diarrhea, and no patients experienced grade 4 diarrhea or required hospitalization. Schmidt is optimistic about this data, as the company plans on submitting a NDA for neratinib in Q1/2016. However, he believes the current  9-month time frame of evaluation is not enough to fully evaluate effectiveness. Rather, he believes data should be evaluated after 12 months.

He states, "High-dose loperamide prophylaxis appears to be working… Nonetheless, today's dataset is the first to demonstrate that loperamide is also capable of lowering diarrhea rates in the extended adjuvant setting, neratinib's first targeted indication… it appears that loperamide prophylaxis is having a very meaningful impact on reducing diarrhea rates."

He continued, "On the other hand, it must be remembered that today's data set is preliminary in that the first patients enrolled in February 2015 have completed just 9 months of therapy with neratinib (vs. 12 in ExteNET) and that many patients included in the analysis have only been dosed for a few months. While we would expect the majority of cases of diarrhea to occur early, it is likely that some additional cases will be reported as patients continue on therapy through 12 months… Hence it is possible that the filing will need to be amended at a later data with full information from this trial."

The analyst reiterated his market perform rating with no price target. According to TipRanks' statistics, analystEric Schmidt has a 51% success rate recommending stocks with an average return of 27.4% per recommendation.

Similarly, analyst Cory Kasimov of JP Morgan also commented on the study, expressing positive sentiment on the results. He states, "When utilizing the Imodium prophylaxis, the diarrhea rates show a similar decline after the first few cycles and rarely return afterwards… We believe this is a major impact in favor of the Imodium prophylaxis since it shortens the diarrhea event and stops it from becoming a chronic issue like we see with some other targeted therapies." He continues, "Bottom line, we continue to see neratinib as approvable, at least for the HR+ subgroup given the ExteNET update at SABCS, and believe that the data shared today support the benefit-risk profile for those patients."

According to the four analysts polled by TipRanks in the last 3 months, 3 are bullish on PUMA while one remains neutral. The average 12-month price target between these 4 analysts is $171.33, marking a 132% potential upside from where shares last closed.