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Puma (PBYI) Stock Surges as Neratinib Nears FDA Approval

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Puma Biotechnology, Inc. (PBYI - Free Report) is a Los Angeles, CA-based biopharmaceutical company, focused on the development and commercialization of innovative treatments that enhance cancer care.

Puma’s stock has significantly outperformed the Zacks classified Medical-Biomed/Genetics industry in the year so far. To be precise, the stock has jumped 159.2% during this period compared with the industry’s increase of 3.1%.



Puma has made some significant progress with the lead candidate, neratinib. While neratinib is under review in the EU for an extended adjuvant treatment of HER2-positive early-stage breast cancer, it is under FDA review for the extended adjuvant treatment of patients with early-stage HER2 over expressed/amplified breast cancer. In the latter case, the pateints have been also previously treated with Roche Holding AG’s (RHHBY - Free Report) cancer drug Herceptin-based adjuvant therapy.

Importantly, an FDA advisory committee recommended approval for neratinib in May this year, which has significantly increased the candidate’s chance to get an FDA approval. Shares have drastically soared after the panel win.

The positive recommendation was based on data from a clinical development program which included 11 trials in breast cancer and showed that the risk-benefit profile of neratinib is favorable. Particularly, the phase III two year ExteNET study was the focus of the meeting.

In the study, patients who had been previously treated with Herceptin-based adjuvant therapy for a year were administered continuous therapy with neratinib for another year.

Data from the study showed that within two years after treatment with neratinib, the patients demonstrated a statistically significant relative reduction of 33% in the risk related to invasive disease recurrence.

An approval of neratinib would be a huge boost for Puma, given the immense commercial potential in the target market. Breast cancer is the second leading cause of cancer-related deaths in women across the world. Approximately one in five women diagnosed with breast cancer worldwide is expected to have HER2-positive breast cancer, a particularly aggressive form of the disease.

The estimated total market opportunity for neo-adjuvant HER2-positive breast cancer is $1- $2 billion. Several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway.

Puma believes that neratinib can also be developed for treating other cancers, including non-small cell lung cancer (NSCLC) and other tumor types that over-express or have a mutation in HER2.

NSCLC is a difficult-to-treat disease, accounting for about 85% of lung cancer cases. The NSCLC market also has a significant commercial potential.

Conclusion

Though HER2-positive breast cancer market provides immense commercial potential, neratinib is notably set to face intense competition, upon approval. Approved treatments include Roche’s Herceptin, Perjeta and Kadcyla, GlaxoSmithKline plc’s (GSK - Free Report) Tykerb and Novartis AG’s (NVS - Free Report) Kisqali.

In addition, quite a few companies are working to bring about cancer curative treatments to the table, targeting this particular disease in the market. However, neratinib looks promising at this juncture and the impending approval will be a huge boost to the company.

Zacks Rank

Puma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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