Shares of Puma Biotechnology, Inc. PBYI have rallied 24% in the past three months against the industry’s decline of 9.7%.

The company’s sole marketed product, Nerlynx (neratinib), is approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s RHHBY Herceptin-based adjuvant therapy.

In the first nine months of 2024, Nerlynx generated sales worth $140.8 million. Sales of the drug improved in the third quarter of 2024 and came ahead of management’s expectations.

Owing to the better-than-expected sales, PBYI updated its financial guidance for 2024 during the third quarter of 2024. The company now expects Nerlynx’s product sales to be in the range of $187-$190 million in 2024, compared with the earlier projection of $183-$190 million.

The improved sales of Nerlynx have been the primary reason for the stock’s increase during the said time.

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PBYI's Recent Developments With Alisertib

Puma Biotechnology in-licensed global development and commercialization rights for alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022. The company is currently focusing on developing alisertib for the treatment of various cancer indications.

Last month, PBYI initiated the phase II ALISCA-Breast1 study evaluating alisertib for the treatment of patients with metastatic breast cancer.

The ALISCA-Breast1 study is investigating alisertib in combination with endocrine therapy for treating HR+, HER2-negative recurrent or metastatic breast cancer in patients who have been previously treated with CDK 4/6 inhibitors and have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.

Based on the outcomes of the ALISCA-Breast1 study, the company plans to meet the FDA for a potential approval pathway for alisertib in HER2-negative, HR+ metastatic breast cancer.

PBYI is also conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from this study is expected to be presented in 2025.

If successfully developed, alisertib, has the potential to boost the company’s position in the anticancer drug market and lower its heavy dependence on Nerlynx for revenues.

PBYI Solely Dependent on Nerlynx for Revenues

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.

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. Though Nerlynx improved in the third quarter, sales of the drug have declined in previous quarters.

PBYI expects Nerlynx product sales to be in the band of $46-$48 million in the fourth quarter of 2024. It remains to be seen whether the same exceeds management’s expectations again.

The improving sales of Nerlynx and the successful development of alisertib should continue the upward momentum for PBYI stock in 2025.

PBYI's Zacks Rank & Other Key Picks

Puma Biotechnology currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR and Spero Therapeutics, Inc. SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.80 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.33 to $1.57 during the same time. Year to date, shares of IMCR have declined 55.7%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Loss per share estimates for 2025 have narrowed from $1.54 to 79 cents during the same time. Year to date, shares of SPRO have declined 35.8%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

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