Puma Biotechnology | $PBYI Stock | Shares Climb Up as Company Announced FDA Approval for NERLYNX

Puma Biotechnology

Puma Biotechnology, Inc. (NASDAQ: PBYI)


Puma Biotechnology, Inc. (PBYI),  a biopharmaceutical company yesterday announced that the U.S Food and Drug Administration approved NERLYNX (neratinib). Neratinib is the company’s inhibitor used to treat adult patients in early stages of breast cancer.

The treatment showed a statistically significant reduction in invasive disease recurrence versus the placebo. Neratinib will be the first anti-HER2 treatment to be approved by the FDA.  

Puma expects neratinib to hit the market by September 2017.


Puma Biotechnology, Inc. CEO’s  Comments

“Despite advances in the treatment of early stage HER2-positive breast cancer, there remains a need for further therapeutic improvements in order to attempt to further reduce the risk of disease recurrence,” said Puma Biotechnology CEO and President Alan H. Auerbach. “We are pleased to be able to bring this new medicine to patients with breast cancer. We would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial.”  Business Wire


PBYI Technical Analysis

Puma Biotechnology

PBYI opened trading yesterday at $89.50 which was down from the previous day’s trading close of $89.55. PBYI closed trading yesterday at $86.10 and spiked up after market to $94.00, equivalent to a 9% increase from the closing price. Taking a look at the daily chart we can see the last time PBYI traded above these levels we have to go back to July 13th when it traded at $94.70.

Taking a closer look at the daily chart we can see that before the spike up PBYI had already been in an overall upward trend dating back to May 8th when it traded at $29.00. PBYI has a float of 23.08 million shares and traded below the normal daily trading volume on Monday.

For day trading purposes, I would like to see PBYI open trading on Tuesday above $91.50 or the VWAP and if it does I would be looking to take a long position at the bell. My stop loss would be $0.50 from my entry position fearing anything more than that and the stock would start to fill in the gap up.


Company Profile

Puma Biotechnology, Inc., a biopharmaceutical company, focuses on the development and commercialization of products to improve cancer care.

Its drug candidates include PB272 (neratinib (oral)) for the treatment of early stage breast cancer, metastatic breast cancer, non-small cell lung cancer, HER2 mutation-positive solid tumors, and HER2-mutated non-amplified breast cancer; and PB272 (neratinib (intravenous)).

The company also develops PB357, an orally administered agent that is an irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4.

It has a license agreement with Pfizer, Inc. for the development, manufacture, and commercialization of PB272 neratinib (oral), PB272 neratinib (intravenous), PB357, and certain related compounds. Puma Biotechnology, Inc. was founded in 2010 and is headquartered in Los Angeles, California. Yahoo Finance