Puma Biotechnology, Inc. (PBYI) Falls on Delay of New Drug Application

Shares of Los Angeles, California, based Puma Biotechnology, Inc. (PBYI) fell sharply on Tuesday, against the backdrop of a generally higher day in stocks overall. Puma's stock was down 21.06%, falling $7.45 per share, to close at $27.92, on volume of 4,184,129 shares. The company's stock fell as a result of an announcement late Monday that the company wants to move a critical new drug application (NDA) with the Food and Drug Administration (FDA) out to a later date this year.

Founded in 2010, Puma Biotechnology, Inc. is a development stage biopharmaceutical company.
It acquires and develops innovative products for the treatment of various forms of cancer. The company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. The company's stock trades on the NYSE.

Puma's stock plummeted on Tuesday, following the announcement Monday evening that the company will delay submission of the NDA for Neratinib, a drug used in the treatment of extended adjuvant breast cancer that has previously been treated with a trastuzumab-containing regimen. The company now plans to submit the drug for FDA approval sometime in the middle of 2016. The market reacted to the news by selling off sharply.

The company has recently conducted several meetings and communications with the FDA, the purpose of which was to provide the regulatory agency data from nertinib's nonclinical and clinical development programs that will form the basis of the NDA for the drug. The discussions with the FDA have included preclinical data and clinical trial date, including the data from certain Phase III and Phase II trials of neratinib in the extended adjuvant treatment of HER2-positive early stage breast cancer.

Following its review of this material, the FDA requested that Puma amend the current statistical analysis plan for the ExteNET trial to incorporate the FDA’s recommendations with regard to rules for censoring the data for recurrent disease events or death. The FDA’s requested approach was a sensitivity analysis used in the ExteNET trial’s original statistical analysis plan but will now be the primary analysis approach used in the trial’s updated statistical analysis plan. Accommodating this change is what has lead Puma to delay filing its NDA.

In addition to the NDA delay, an analyst at Credit Suisse lowered the target price on the stock. Analyst K. MacKay lower the target price of Puma's stock from $69 down to $50. The downgrade was the result of the delay in submitting the NDA. Said MacKay, "We are disappointed by the timeline delay, and our conversations with management suggest this was following a 'Type A' FDA meeting last week, which we see as adding regulatory risk. Despite this, we continue to see neratinib as approvable in the extended-adjuvant setting."

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Puma Reports In Line Q4 Loss, Neratinib in Focus
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Published on Mar 30, 2016
By Kevin Mercadante

Copyrighted 2016. Content published with author's permission.

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