Shares of Puma Biotechnology, Inc. (PBYI) were down in after-market hours trading following the company’s announcement that the New Drug Application (NDA) for its pipeline candidate neratinib (PB272) will be delayed till the first quarter of 2016.
We remind investors that Puma Biotechnology had earlier announced that the NDA will be filed in the first half of 2015 based on the feedback it had previously received from regulatory agencies. It had mainly focused on the proposed clinical indication of HER2-positive metastatic breast cancer.
However, the company’s initial NDA filing will now include the extended adjuvant HER2-positive early-stage breast cancer indication. Consequently, Puma Biotechnology will need to submit data from preclinical carcinogenicity studies with its NDA filing, as per the International Conference on Harmonization guidelines, pushing the deadline to 2016.
We note that Puma Biotechnology has a licensing agreement with Pfizer (PFE) for neratinib.
Our Take
Puma Biotechnology carries a Zacks Rank #4 (Sell). The delay in the NDA filing is quite disappointing as the company has no approved products and neratinib is its lead pipeline candidate. This will consequently delay the potential approval, thereby impacting Puma Biotechnology's growth prospects.
Last month, the company announced disappointing top-line results from a randomized, two-arm, phase II study (NEfERTT) on neratinib, wherein neratinib in combination with paclitaxel, failed to show significant improvement in progression-free survival in patients suffering from first-line HER2-positive locally recurrent or metastatic breast cancer when compared to paclitaxel plus Roche’s (RHHBY) Herceptin.
We remind investors that Roche is a dominating player in the breast cancer market with drugs like Herceptin, Perjeta and Kadcyla.
Meanwhile, Puma Biotechnology is also evaluating neratinib for the treatment of patients suffering from non small cell lung cancer and other solid tumors with HER2 mutation.
A better-ranked stock in the health care sector is Biogen Idec Inc (BIIB), carrying a Zacks Rank #1 (Strong Buy).
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