Puma Biotech Sinks On Drug Data; Analyst Upbeat

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Puma Biotechnology Inc PBYI plunged more than 13 percent on Tuesday after disappointing drug trial results, even as an analyst called the data "clearly positive."

The development-stage biopharmaceutical company traded recently at $146.83, off $23.14, on more than three times the average volume.

On Monday Puma said the two-year, disease free survival rate for breast cancer victims taking its neratinib drug was 93.9 percent, versus 91.6 percent for patients treated with a placebo.

About 40 percent of the neratinib patients experienced diarrhea.

The trial included 2,840 patients treated with either neratinib or placebo for one year. Patients were then followed for recurrent disease for an additional year.

Although Puma shares are off nearly 25 percent since Friday, "the argument that the trial had a low absolute benefit is weak," RBC's Simos Simeonidis said.

Simeonidis, who reiterated an Outperform rating on Puma, said several currently approved breast cancer drugs "had similar levels of absolute benefit" when approval applications were filed.

As examples, Simeonidis cited Novartis AG's NVS letrozole, AstraZeneca plc's AZN Arimidex and Pfizer Inc.'s PFE Aromasin.

Certain subpopulations of patients within the Puma study saw about double the average anti-cancer benefit, while Simeonidis said diarrhea was reduced to about 12 percent of patients who received preventative treatments.

"It was clearly a positive trial," according to Simeonidis, who expects Puma will submit the drug for marketing approval in the first quarter of 2016.

"We continue to view neratinib as an approvable drug," Simeonidis said.

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Posted In: Analyst ColorBiotechHealth CareReiterationFDAAnalyst RatingsGeneralRBCSimos Simeonidis
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