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Puma Biotech's (PBYI) Nerlynx Gets Approval in Australia

Zacks Equity Research

Puma Biotechnology, Inc. PBYI announced that the regulatory body in Australia has granted a marketing approval to its kinase inhibitor, Nerlynx (neratinib). The drug is 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.

Notably, Puma’s Australian licensing partner Specialised Therapeutics Asia (STA) has received the marketing authorization from Australia’s Therapeutic Goods Administration (TGA).

Meanwhile, STA has submitted a regulatory application in Singapore to get Nerlynx approved for the same indication. The same also plans to file regulatory petitions in South East Asia including Malaysia, Brunei, Vietnam and Thailand for getting Nerlynx approved.

Shares of Puma were up 7.8% following this news on Monday. In fact, so far this year, the stock has skyrocketed 108.2%, significantly outperforming the industry’s increase of 15.6%.


The above approval was based on data from the phase III ExteNET study, which evaluated Nerlynx following Herceptin-based adjuvant treatment in women. Results from the evaluation demonstrated that patients treated with Nerlynx achieved a 34% reduction in the risk of invasive disease recurrence or death compared with placebo after patients completed a year of Nerlynx regimenfollowing a Hereceptin-based treatment.

Additional five-year data shows that Nerlynx lowers the risk of invasive disease relapse or death by 42% in women afflicted with early-stage HER2-positive breast cancer. Following the nod, Nerlynx became the first anti-HER2 treatment to be approved in Australia.

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

In a separate press release, Puma announced updated interim results from the ongoing phase II SUMMIT basket study on Nerlynx for treating patients, suffering HER2 mutated cervical cancer. The data was presented at the Society of Gynecologic Oncology (SGO) 2019 annual meeting in Honolulu, Hawaii.

The study evaluated the safety and efficacy of Nerlynx as a monotherapy in 11 patients with advanced/metastatic cervical cancer. The median progression free survival was 7 months.

Outcomes from the program showed that treatment with Nerlynx led to durable responses and disease control in metastatic patients, down with HER2-mutant cervical cancer.

Zacks Rank & Other Key Picks

Puma currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the biotech sector include Celgene Corp. CELG and Trevena, Inc. TRVN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings estimates have moved 3.8% north for 2019 and 3.9% for 2020 over the past 60 days. The stock has surged 37.3% so far this year.

Trevena’s loss per share estimates have been narrowed 40.3% for 2019 and 68.5% for 2020 in the last 60 days. The stock has skyrocketed 288.4% year to date.

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