Puma Biotechnology, Inc. PBYI announced the initiation of a phase II study (n=70) on its oncology candidate, neratinib (PB272). Neratinib is being developed for the treatment of breast cancer. Puma Biotechnology’s shares gained around 2.6% after the news.
The open label, single arm, phase II study will evaluate neratinib as monotherapy in patients suffering from HER2-positive early stage breast cancer who have previously received adjuvant treatment with Roche’s RHHBY Herceptin (trastuzumab). Patients enrolled in the study will be receiving extended adjuvant treatment with neratinib for one year. In addition, they will receive primary prophylaxis with high-dose loperamide to reduce neratinib-related diarrhea.
The primary endpoint of the study is the reduction in the incidence and severity of diarrhea. Puma Biotechnology expects initial results from the study by the end of 2015. The company also plans to include data from the study in the new drug application (NDA) filing of neratinib, which is currently expected in the first quarter of 2016.
We remind investors that toward the end of last year, Puma Biotechnology announced a delay in the NDA filing of neratinib which was previously expected in the first half of 2015. The company’s decision was based on feedback from regulatory agencies.
Puma Biotechnology has a licensing agreement with Pfizer PFE for neratinib.
Our Take
The study initiation is encouraging. However, positive outcomes from the study are important for the company. The company has no approved product and neratinib is its lead pipeline candidate. The delay in the NDA filing is already impacting Puma Biotechnology's growth prospects. We expect investor focus to stay on updates on neratinib going forward.
Presently, Roche has several breast cancer drugs on the market including Herceptin, Perjeta and Kadcyla.
Puma Biotechnology carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Cytokinetics, Inc. CYTK, carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment