Puma Biotechnology’s PBYI sole marketed product, Nerlynx (neratinib), is witnessing strong sales uptake owing to increasing demand in the United States. The company's top line is primarily driven by sales of Nerlynx as well as royalty revenues.
Nerlynx is approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s RHHBY Herceptin-based adjuvant therapy. The drug is also approved in combination with Xeloda (capecitabine) for treating advanced or metastatic HER2-positive breast cancer patients who have received two or more prior anti-HER2-based regimens in the metastatic setting.
In the first six months of 2026, Nerlynx sales increased 3.5% year over year to $95.5 million. Reflecting this, the company increased its Nerlynx sales outlook for 2026. Nerlynx sales are now expected to be in the range of $205-$209 million in 2026 versus the earlier expectation of $202-$206 million.
The raised guidance reflects management's confidence in Nerlynx's growth prospects and points to stronger demand trends for the product.
Building on this growing momentum, we expect investors to keep a close eye on Nerlynx’s sales performance when PBYI reports its third-quarter 2026 results next month.
Nerlynx sales are likely to have been aided by demand-driven growth in the third quarter of 2026. The company expects net product revenues from Nerlynx to be between $54 million and $56 million in the third quarter of 2026.
While the breast cancer market holds immense commercial potential, Nerlynx faces intense competition in the targeted space. Approved treatments include Roche's Herceptin and Novartis' NVS Tykerb. A few other companies are also developing treatments targeting this disease.
PBYI’s Ongoing Pipeline Progress
Puma Biotechnology is developing its pipeline candidate, alisertib, an aurora kinase A inhibitor, in separate mid-stage studies for treating hormone receptor-positive breast cancer and small-cell lung cancer.
Last month, the company initiated the phase II ALISCA-Lung2 study evaluating alisertib in combination with paclitaxel for the treatment of patients with advanced small-cell lung cancer.
Puma Biotechnology is also evaluating alisertib as a monotherapy in the ongoing ALISCA-Lung1 study for treating patients with extensive-stage small-cell lung cancer. The company expects both studies to advance the clinical development of alisertib in small-cell lung cancer.
Besides lung cancer, the company is also developing alisertib for hormone receptor-positive breast cancer.
The phase II ALISCA-Breast1 study is investigating alisertib in combination with endocrine treatment for treating patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Updated data from the study are expected in the fourth quarter of 2026.
Per management, alisertib has huge potential in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer and SCLC. If successfully developed for the given indications, alisertib has the potential to boost the company’s position in the anticancer drug market while creating long-term growth visibility.
Also, sustained sales of Nerlynx could help support the company’s top line and provide a relatively stable revenue base.
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