Puma Biotechnology, Inc.( PBYI Quick Quote PBYI - Free Report) is a biotechnology company focused on research in cancer. The company’s only marketed product, Nerlynx (neratinib), is approved for the treatment of early-stage HER2-positive breast cancer in patients who have been previously treated with Roche’s ( RHHBY Quick Quote RHHBY - Free Report) Herceptin-based adjuvant therapy.
Puma Biotechnology markets Nerlynx in the United States and has several sub-licenses in various regions outside the United States to commercialize the product in certain international markets.
Here are some reasons why investors should consider betting on Puma Biotechnology stock.
Good Rank, Rising Share Price and Estimates: Puma Biotechnology currently has a Zacks Rank #1 (Strong Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents.
The stock has increased 26.2% in the past six months against the
industry’s decline of 17.3%. Image Source: Zacks Investment Research Nerlynx Driving Sales: Nerlynx is witnessing improving demand trends. The majority of the company’s revenues are derived from the sales of Nerlynx. In the first nine months of 2023, the drug generated sales of $149.9 million, up 2.5% year over year.
Notably, in February 2020, the FDA approved Nerlynx in combination with Roche’s Xeloda to treat third-line HER2-positive metastatic breast cancer based on data from the phase III NALA study. The approval to include the NALA study outcome in Nerlynx’s label has helped address a broader breast cancer population, thereby driving higher sales. Puma Biotechnology has also received additional approvals for using Nerlynx in the extended adjuvant population.
Acquisition of Alisertib Holds Promise: In September 2022, Puma Biotechnology in-licensed global development and commercialization rights for alisertib, an aurora kinase A inhibitor, from Japan’s Takeda.
In August 2023, the FDA cleared the investigational new drug application to begin clinical development of alisertib to treat patients with small cell lung cancer (SCLC). PBYI plans to initiate a phase II PUMA-ALI-4201 study later in the fourth quarter of 2023. In September 2023, the FDA
granted Orphan Drug designation to alisertib for patients with SCLC.
Strong performance of Nerlynx and encouraging pipeline progress are some of the reasons for the stock’s rise during the above mentioned period.
Puma Biotechnology believes that alisertib has the potential in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer and SCLC, based on the results of the already completed studies on the candidate.
Huge Potential in HER2+ Breast Cancer Market: Breast cancer is the most common malignancy and is the leading cause of cancer-related death in women across the world. More than 2 million new cases of breast cancer are reported every year, with more than 500,000 deaths per year globally. Some breast cancer tumors show an over-expression of the HER2 protein, which increases the risk of disease recurrence, progression and death. Though the outcomes associated with this disease have improved significantly with the use of targeted therapies, resistance to these approaches remains an unmet medical need. Other Stocks to Consider
Some other top-ranked stocks in the biotech sector are
CytomX Therapeutics, Inc. ( CTMX Quick Quote CTMX - Free Report) and Ligand Pharmaceuticals Incorporated ( LGND Quick Quote LGND - Free Report) , sporting a Zacks Rank #1 each.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 17.5%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 13.4%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.