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Puma Biotech's (PBYI) Nerlynx Aids Top Line, Overdependence a Woe
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Puma Biotech’s (PBYI - Free Report) lead drug Nerlynx, an oral version of neratinib, is a potent irreversible tyrosine kinase inhibitor ("TKI”) used to treat positive HER-2 breast cancer. Nerlynx is the only marketed drug in the company’s portfolio.
Nerlynx has been approved by the FDA for the extended adjuvant treatment of adults with early HER-2 positive breast cancer, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy. The drug is also approved for use in the European Union for the same indication.
Additionally, Nerlynx has been FDA-approved to be used in combination with Roche’s Xeloda (capecitabine) for HER-2 positive patients who have received two or more lines of anti-HER2 therapy.
In order to commercialize Nerlynx outside U.S. markets, the company entered into exclusive license agreements with various partners like Pierre Fabre in Europe outside of the country.
In the last reported quarter, Nerlynx revenues were up 4.9% year over year, at $51.3 million. In the same time period, Nerlynx sales increased sequentially by almost 26% due to inventory built at specialty pharmacies/distributors.
Shares of Puma Biotech have returned 3.2% in the year-to-date period against the industry’s decline of 20.7%.
Image Source: Zacks Investment Research
Additionally, Puma is evaluating neratinib in several additional studies targeting different types of breast cancers and other types of cancers.
A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutated cancers.
In June, Puma announced a 35.3% objective response rate at a median progression-free survival of 8.2 months from a cohort of the SUMMIT study. The study assessed the efficacy of neratinib in combination with fulvestrant and trastuzumab in patients with HR-positive, HER2-negative and HER2-mutant metastatic breast cancer. Puma Biotech intends to hold a pre-NDA meeting with the FDA to discuss these results and seek approval for the aforementioned indication under the accelerated pathway.
The company intends to release data from another cohort of the SUMMIT study evaluating neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations by the end of 2022.
A potential label expansion of Nerlynx, if approved, in the above-mentioned indications, should improve its sales in the near term.
Puma’s overdependence on Nerlynx and the lack of any potential pipeline candidate in its portfolio might be a major concern. If Nerlynx witnesses a regulatory setback in any of the indications it is currently being evaluated for, it will hurt the stock price significantly
Moreover, Nerlynx faces stiff competition in HER2-positive breast cancer market from Roche’s Herceptin, Perjeta and Kadcyla, Novartis’ (NVS - Free Report) Kisqali and AstraZeneca’s (AZN - Free Report) Enhertu
AZN’s Enhertu is currently approved in more than 40 countries for HER-2 positive breast cancer. It is also approved for HER-2 positive gastric cancer in several countries. Earlier this month, Enhertu was also approved for its third indication, HER2-mutant metastatic non-small cell lung cancer.
Novartis’ Kisqali is also FDA-approved for the first-line treatment of postmenopausal women with HR+/HER2 advanced or metastatic breast cancer. Kisqali has become an important growth driver for Novartis.
Image: Bigstock
Puma Biotech's (PBYI) Nerlynx Aids Top Line, Overdependence a Woe
Puma Biotech’s (PBYI - Free Report) lead drug Nerlynx, an oral version of neratinib, is a potent irreversible tyrosine kinase inhibitor ("TKI”) used to treat positive HER-2 breast cancer. Nerlynx is the only marketed drug in the company’s portfolio.
Nerlynx has been approved by the FDA for the extended adjuvant treatment of adults with early HER-2 positive breast cancer, previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy. The drug is also approved for use in the European Union for the same indication.
Additionally, Nerlynx has been FDA-approved to be used in combination with Roche’s Xeloda (capecitabine) for HER-2 positive patients who have received two or more lines of anti-HER2 therapy.
In order to commercialize Nerlynx outside U.S. markets, the company entered into exclusive license agreements with various partners like Pierre Fabre in Europe outside of the country.
In the last reported quarter, Nerlynx revenues were up 4.9% year over year, at $51.3 million. In the same time period, Nerlynx sales increased sequentially by almost 26% due to inventory built at specialty pharmacies/distributors.
Shares of Puma Biotech have returned 3.2% in the year-to-date period against the industry’s decline of 20.7%.
Image Source: Zacks Investment Research
Additionally, Puma is evaluating neratinib in several additional studies targeting different types of breast cancers and other types of cancers.
A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutated cancers.
In June, Puma announced a 35.3% objective response rate at a median progression-free survival of 8.2 months from a cohort of the SUMMIT study. The study assessed the efficacy of neratinib in combination with fulvestrant and trastuzumab in patients with HR-positive, HER2-negative and HER2-mutant metastatic breast cancer. Puma Biotech intends to hold a pre-NDA meeting with the FDA to discuss these results and seek approval for the aforementioned indication under the accelerated pathway.
The company intends to release data from another cohort of the SUMMIT study evaluating neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations by the end of 2022.
A potential label expansion of Nerlynx, if approved, in the above-mentioned indications, should improve its sales in the near term.
Puma Biotechnology, Inc. Price
Puma Biotechnology, Inc. price | Puma Biotechnology, Inc. Quote
Puma’s overdependence on Nerlynx and the lack of any potential pipeline candidate in its portfolio might be a major concern. If Nerlynx witnesses a regulatory setback in any of the indications it is currently being evaluated for, it will hurt the stock price significantly
Moreover, Nerlynx faces stiff competition in HER2-positive breast cancer market from Roche’s Herceptin, Perjeta and Kadcyla, Novartis’ (NVS - Free Report) Kisqali and AstraZeneca’s (AZN - Free Report) Enhertu
AZN’s Enhertu is currently approved in more than 40 countries for HER-2 positive breast cancer. It is also approved for HER-2 positive gastric cancer in several countries. Earlier this month, Enhertu was also approved for its third indication, HER2-mutant metastatic non-small cell lung cancer.
Novartis’ Kisqali is also FDA-approved for the first-line treatment of postmenopausal women with HR+/HER2 advanced or metastatic breast cancer. Kisqali has become an important growth driver for Novartis.
Puma Biotechnology currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.