Puma shares plummet as it delays NDA filing
Puma Biotechnology (NYSE: PBYI) will delay the filing of its New Drug Application (NDA) for the approval of PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. Its shares dropped 24% on the news yesterday.
Puma had intended to file an NDA for PB272 in the first half of 2015, based on feedback it had previously received from regulatory agencies, which had been focused on the proposed clinical indication of HER2-positive metastatic breast cancer.
The company said in a statement: “Since the company’s initial NDA filing will now be for the extended adjuvant HER2-positive early stage breast cancer indication, based on the company’s recent meetings with the US Food and Drug Administration, Puma will need to submit data from preclinical carcinogenicity studies with its NDA filing in accordance with International Conference on Harmonization (ICH) guidelines.”
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