Puma Biotechnology, Inc.’s PBYI shares gained 10.5% after the company announced that its New Drug Application (NDA) for its lead candidate, neratinib (PB272), has been accepted for review by the FDA.
The company is looking to get neratinib approved as an extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, who have been previously treated with Roche Holding AG’s RHHBY Herceptin (trastuzumab)-based adjuvant therapy.
In Jul 2016, Puma Biotech submitted the regulatory application based on results from a phase III (ExteNET) study, which demonstrated a statistically significant reduction (33%) in the risk of invasive disease recurrence or death, in comparison to placebo.
We remind investors that last month, the company’s Marketing Authorisation Application (MAA) for neratinib was validated by the European Medicines Agency (EMA).
Currently, neratinib is in several breast cancer studies. Data from these studies are expected in the second half of 2016 and beyond. Although the company is exploring the possibility of developing an intravenous formulation of neratinib, it is currently focused on an oral formulation of the candidate.
Puma Biotech believes that neratinib can also be developed for the treatment of other types of cancers, including non-small cell lung cancer (NSCLC) and other tumor types that over-express or have a mutation in HER2.
We note that the breast cancer market is heavily crowded with drugs like Faslodex, Ibrance, Herceptin and Femara among others.
With no approved product in the company’s portfolio and neratinib being its lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development. A potential approval will enable the company to generate product revenues for the first time.
Puma Biotech currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector are Anika Therapeutics, Inc. ANIK and ANI Pharmaceuticals, Inc. ANIP. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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