On Jan 20, we issued an updated research report on Puma Biotechnology, Inc. (PBYI - Free Report) . The company’s top line mainly comprises sales of its sole marketed product Nerlynx.
Shares of Puma Biotech have plunged 59% in the past year compared with the industry’s decrease of 1.5%.
Nerlynx is approved in several countries including the United States and Europe as an extended adjuvant treatment of HER2-positive early stage breast cancer in adult patients, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy. The drug was launched in the United States in July 2017 and in other countries thereafter.
Nerlynx generated sales of $152.9 million in the first nine months of 2019, reflecting an increase of 9.7% year over year.
Several studies on Nerlynx targeting different types of breast cancer patient populations and in earlier-line settings are currently underway. In September 2019, the FDA accepted Puma Biotech’s supplemental new drug application (sNDA) seeking approval of Nerlynx in combination with Roche’s Xeloda to treat third-line HER2-positive metastatic breast cancer and set an action date of April 2020 for the same.
The sNDA was based on data from the phase III NALA study, which evaluated the combo of Nerlynx + Xeloda compared to Xeloda plus Novartis’ (NVS - Free Report) Tykerb (lapatinib) for treating patients with HER2-positive metastatic breast cancer, who failed two or more prior lines of treatments.
If the company gets an approval to include the NALA study data on Nerlynx’s label, it will be eligible to treat a broader breast cancer population, which can drive the product’s sales higher.
Apart from the HER2-positive breast cancer indication, the company believes that Nerlynx holds potential to treat several other cancers including NSCLC and other tumor types that over-express or have a mutation in HER2.
A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4mutated cancers.
In October 2019, the FDA approved a labeling supplement for Nerlynx to include safety information based on interim results from the phase II CONTROL study, which evaluated the antidiarrheal prophylaxis or dose escalation in the reduction of Nerlynx-associated diarrhea that had a primary endpoint of the incidence of grade III or higher diarrhea.
However, Puma Biotech has no approved product in its portfolio other than Nerlynx at the moment. Hence, due to lack of a strong pipeline, the company is totally dependent on Nerlynx for growth. As a result, any kind of negative development or a regulatory setback could affect the company’s prospects in the long run.
Puma Biotechnology, Inc. Price and Consensus
Zacks Rank & Key Pick
Puma Biotech currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Epizyme, Inc. (EPZM - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Epizyme’s loss per share estimates have narrowed 2.5% for 2020 over the past 60 days. The stock has skyrocketed 192% in the past year.
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