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PBYI expects 2026 total revenues of $222-$229M, with Nerlynx sales expected to be $202-$206M.
Shares of Puma Biotechnology (PBYI - Free Report) have witnessed a sharp increase in the past three months, driven by investor optimism surrounding the company's strong 2026 revenue outlook. The company's top line is primarily driven by sales of its sole marketed product, Nerlynx (neratinib).
Nerlynx is approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s (RHHBY - Free Report) 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.
Nerlynx sales fell 2.6% year over year to $42 million in the first quarter of 2026. However, the figure surpassed management's guidance range of $36-$39 million, reflecting growing demand for the drug.
Management expects Nerlynx sales to improve as 2026 progresses, supported by favorable demand trends. Building on this optimism, the company raised its financial outlook for 2026 last month.
Improving demand for Nerlynx and the company's raised revenue outlook for 2026 have been the primary drivers of the stock's strong performance over the past three months.
PBYI’s Price Performance
Shares of Puma Biotechnology have rallied 19.4% in the past three months against the industry’s decline of 6.9%.
Image Source: Zacks Investment Research
Strong 2026 Outlook and Pipeline Progress Support PBYI
Puma Biotechnology’s top line currently comprises net product sales of Nerlynx and royalty revenues.
For full-year 2026, total revenues are forecasted in the range of $222-$229 million, while net product revenues from Nerlynx sales are projected to be between $202 million and $206 million.
Previously, the company expected total revenues in the range of $214-$221 million, while net product revenues from Nerlynx were aniticipated to be in the band of $194-$198 million.
The raised guidance reflects management's confidence in Nerlynx's growth prospects and points to stronger demand trends for the product.
PBYI 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 (SCLC).
The company is conducting ALISCA-Lung1, a phase II study (PUMA-ALI-4201) evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. Interim efficacy data from this study are expected in the second half of 2026 or the first half of 2027.
Puma Biotechnology is also conducting a phase II ALISCA-Breast1 study on 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 is also expected to be presented in the second half of 2026.
If successfully developed, alisertib could diversify Puma Biotechnology's cancer portfolio beyond Nerlynx and provide an additional growth driver for the company.
PBYI’s Heavy Reliance on Nerlynx is a Concern
Puma Biotechnology has no approved product in its portfolio other than Nerlynx. As a result, the company remains heavily dependent on Nerlynx for revenues and overall growth.
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' Tykerb. A few other companies are also developing treatments targeting this disease.
Nevertheless, the company's raised 2026 outlook, rising demand for Nerlynx and progress with alisertib development should continue the upward momentum for PBYI stock in 2026.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 89.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 19.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
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Puma Biotechnology Stock Rises 19% in 3 Months: Here's Why
Key Takeaways
Shares of Puma Biotechnology (PBYI - Free Report) have witnessed a sharp increase in the past three months, driven by investor optimism surrounding the company's strong 2026 revenue outlook. The company's top line is primarily driven by sales of its sole marketed product, Nerlynx (neratinib).
Nerlynx is approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s (RHHBY - Free Report) 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.
Nerlynx sales fell 2.6% year over year to $42 million in the first quarter of 2026. However, the figure surpassed management's guidance range of $36-$39 million, reflecting growing demand for the drug.
Management expects Nerlynx sales to improve as 2026 progresses, supported by favorable demand trends. Building on this optimism, the company raised its financial outlook for 2026 last month.
Improving demand for Nerlynx and the company's raised revenue outlook for 2026 have been the primary drivers of the stock's strong performance over the past three months.
PBYI’s Price Performance
Shares of Puma Biotechnology have rallied 19.4% in the past three months against the industry’s decline of 6.9%.
Image Source: Zacks Investment Research
Strong 2026 Outlook and Pipeline Progress Support PBYI
Puma Biotechnology’s top line currently comprises net product sales of Nerlynx and royalty revenues.
For full-year 2026, total revenues are forecasted in the range of $222-$229 million, while net product revenues from Nerlynx sales are projected to be between $202 million and $206 million.
Previously, the company expected total revenues in the range of $214-$221 million, while net product revenues from Nerlynx were aniticipated to be in the band of $194-$198 million.
The raised guidance reflects management's confidence in Nerlynx's growth prospects and points to stronger demand trends for the product.
PBYI 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 (SCLC).
The company is conducting ALISCA-Lung1, a phase II study (PUMA-ALI-4201) evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. Interim efficacy data from this study are expected in the second half of 2026 or the first half of 2027.
Puma Biotechnology is also conducting a phase II ALISCA-Breast1 study on 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 is also expected to be presented in the second half of 2026.
If successfully developed, alisertib could diversify Puma Biotechnology's cancer portfolio beyond Nerlynx and provide an additional growth driver for the company.
PBYI’s Heavy Reliance on Nerlynx is a Concern
Puma Biotechnology has no approved product in its portfolio other than Nerlynx. As a result, the company remains heavily dependent on Nerlynx for revenues and overall growth.
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' Tykerb. A few other companies are also developing treatments targeting this disease.
Nevertheless, the company's raised 2026 outlook, rising demand for Nerlynx and progress with alisertib development should continue the upward momentum for PBYI stock in 2026.
Puma Biotechnology, Inc. Price
Puma Biotechnology, Inc. price | Puma Biotechnology, Inc. Quote
PBYI's Zacks Rank & Stocks to Consider
Puma Biotechnology currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 89.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 19.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.