- Neratinib is a tyrosine kinase inhibitor that was initially developed for treatment of women with HER2-positive metatstatic breast cancer. Neratinib, also known as PB272, was licensed from Pfizer in 2011 by Puma Biotechnology, which is responsible for clinical development and marketing for the drug.
- In phase III trials, neratinib increased disease-free survival in patients by 33% compared with a placebo.
- Puma has announced that it is delaying filing the NDA for neratinib until 2016, a significant delay from the original plan to file in early 2015.
In July, Biopharma Dive reported on neratinib's stellar phase III results. The 33% increase in disease-free survival in women with HER-2 positive metastatic breast cancer helped lead to a 300% increase in Puma's stock price.
In light of recent discussions with regulatory agencies, Puma is changing the proposed indication for neratinib from HER2-positive metatstatic breast cancer to extended adjuvant HER2-positive early stage breast cancer. This shift will cost a few months, but neratinib represents an opportunity to address an unmet medical need.
In July, Puma's stock rose to $227 per share. At the close of the market yesterday, Puma was still trading at $225 per share—but concern over the delayed NDA likely led to a plummet in after hours trading, when the stock fell to about $185 per share. What remains to be seen is just how long that slump will last.