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Puma Biotech Adds Two Cohorts to Nerlynx Label Expansion Study

Zacks Equity Research

Puma Biotechnology, Inc. PBYI announced that it has added two cohorts to the phase II SUMMIT basket study on Nerlynx (neratinib), which is currently being conducted for treating solid tumors in patients with activating EGFR, HER2 or HER4mutations.

Nerlynx is already approved as an extended adjuvant treatment of HER2-positive early stage breast cancer in adult patients, previously treated with Roche’s RHHBY Herceptin-based adjuvant therapy.

The phase II SUMMIT basket study is designed to evaluate the safety and efficacy of Nerlynx for solid tumors with activating EGFR, HER2 or HER4 mutations. The couple of new cohorts will enroll 18 patients each, who are afflicted with HER2-positive metastatic salivary gland cancer and EGFR exon 18 mutation-positive lung cancer.

Notably, last month, Puma Biotech posted updated interim results from the same study on a different cohort, evaluating patients with HER2 mutated cervical cancer. Outcomes from the study showed that treatment with Nerlynx led to durable responses and disease control in metastatic patients suffering HER2-mutant cervical cancer.

We would like to remind investors that Nerlynx was approved in the United States in July 2017 and in Europe last September. Sales of the drug have improved steadily since its launch and were above the management’s expectations last year. For 2018, Nerlynx generated sales of $200.5 million, slightly higher than the company’s guided range of $175-$200 million.

Meanwhile, several label expansion programs on Nerlynx targeting different types of breast cancer patient populations and earlier-line settings are currently underway.

Apart from the HER2-positive breast cancer indication, Puma Biotech believes that Nerlynx holds great prospects for addressing various other cancer types. The drug’s label extension will thus allow treatment and access to a wider subject base, thereby boosting its sales in the future.

Shares of Puma Biotech have soared 68.9% so far this year, outperforming the industry’s rally of 14.4%.

Zacks Rank & Other Stocks to Consider

Puma Biotech currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the healthcare sector include Kamada Ltd. KMDA and PDL BioPharma, Inc. PDLI, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Kamada’s earnings estimates have been revised 34.3% upward for 2019 and 5% for 2020 over the past 60 days. The stock has risen 15.2% so far this year.

PDL BioPharma’s earnings estimates have moved 100% north for 2019 and 30% for 2020 over the past 60 days. The stock has gained 27.6% year to date.

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