Shares of Puma Biotechnology, Inc. (PBYI - Free Report) have significantly outperformed the industry in the year so far. The stock has skyrocketed 242.1% compared with the industry’s increase of 0.8% during this period.
The FDA approval of Puma’s cancer drug Nerlynx (neratinib) in the United States this year coupled with strategic collaborations have appreciated the company’s share price consistently.
Notably, Nerlynx received the FDA approval in July for the extended adjuvant treatment of patients with early-stage HER2 over expressed/amplified breast cancer, having been previously treated with Roche’s (RHHBY - Free Report) Herceptin-based adjuvant therapy. Significantly, Nerlynx is the first anti-HER2 treatment to be approved as an extended adjuvant therapy for the aforementioned indication.
The FDA approval of Nerlynx for breast cancer was a huge boost to Puma, given the immense commercial potential in the target market. The drug was made commercially available in the United States in August. It is also under review in the EU for the same indication with an opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA expected in the first quarter of 2018.
In the third-quarter, the company recorded revenues of $6.1 million from initial sales of Nerlynx. In October, Puma entered into a credit facility with Silicon Valley Bank and Oxford Finance to support Nerlynx commercial initiatives.
Several additional studies on Nerlynx targeting different types of breast cancer patient populations are also underway.
Puma believes that Nerlynx can also be developed for treating other cancers, including non-small cell lung cancer (NSCLC) and other tumor types that over-express or have a mutation in HER2.
Moreover, in November, Puma entered into an exclusive licensing agreement with Specialised Therapeutics Asia, a Singapore-based biopharmaceutical company to commercialize Nerlynx in Australia, New Zealand and South-East Asia. This agreement will provide the company with funds in the form of milestone payments and double-digit royalties on Nerlynx sales. Specialised Therapeutics will also seek to get the drug approved in other countries like Singapore, Malaysia, Brunei and New Zealand.
About 25% of HER2-positive early-stage breast cancer patients treated with Herceptin-based adjuvant treatment experience a recurrence. Hence, the consent for Nerlynx in additional countries will be a huge boost to Puma as the company is expected to address the hugely unmet medical need of patients experiencing the relapse of the disease worldwide.
Though HER2-positive breast cancer market provides immense commercial potential, Nerlynx is facing competition from established products which include Roche’s Herceptin, Perjeta and Kadcyla, GlaxoSmithKline plc's (GSK - Free Report) Tykerb and Novartis AG's (NVS - Free Report) Kisqali.
Additionally, quite a few companies are working to bring about cancer curative treatments to the table for the target market.
However, Nerlynx looks promising at this juncture with several other studies targeting other cancer forms.
Puma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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