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Puma Biotechnology, Inc. (PBYI) is a biopharmaceutical company.
The firm 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.
Shares have formed a bullish "flag" ahead of FDA's meeting on the company's brast cancer drug. The FDA has scheduled a May 24 Advisory Committee meeting for Puma’s neratinib in extended adjuvant treatment of “HER2” early stage breast cancer. In its Q1 earnings report last night, the company confirmed that “we look forward to presenting” at the May 24 meeting.
In a post-earnings research note, Citi’s analyst highlights that Puma accelerated plans for final five-year data from the ” #ExteNET ” neratinib trial to Q2 from the second half, as it will be used during the drug’s May 24 #AdComm. The analyst confirmed with Puma that additional data from the “CONTROL” prophylactic trial will also be presented at the meeting.
Notably, the analyst says he “noticed” that Puma appears to be actively hiring for commercial operations, with the company’s website now showing 18 job listings for roles within outreach, commercial supply chain, market access, reimbursement, and other areas. Though critics may interpret the news as signaling that Puma doesn’t expect to be acquired, the analyst counters that such an argument “doesn’t work too well tactically,” as the stock should gain at least 100% on what he calls an “expected positive” AdComm. Higher share prices are expected for this stock.
52-Weeks Trading Range: $27.64 - $73.27
Entry Point: $37.80
Stop Loss: $35.90
Target Price: $41.58
PBYI closed at $69.35
