Puma Biotechnology Inc (NASDAQ:PBYI) claims that its breast cancer drug, Neratinib, has stronger efficacy in high-risk breast cancer patients. Thus is it likely to be ahead of its rival Roche’s combination treatment. This conviction may have been resulted in its skyrocketing stock this to over $38.
The company’s shares were also upgraded from a hold rating to a buy rating by Zacks Investment Research having reported almost a loss in the first quarter of 2017.
But Puma’s Neratinib is still enlisted for further examination
According to Matthew Eckler, an RBC analyst, experts are of the opinion that Puma’s neratinib could still be the ideal in a subset of breast cancer patients given that it is an adjuvant treatment. Adjuvant therapies have a record of decreasing the risk of cancer returning.
However, the new drug’s application will still have to undergo an examination with the Oncologic Drugs Advisory Committee. Depending on the outcome of the evaluation, the panel can advise on whether or not it is worth approval by the FDA.
Meanwhile, Puma is aware of the many questions that may arise. The biotech will be required to make its case to the board about the effectiveness of neratinib. Eckler notes, “We expect (the focus to be) on lingering questions around (neratinib’s) benefit/risk profile, trial changes and the impact of Aphinity.”
But Roche’s trial results of Aphinity are not out yet
Aphinity consists if a combination of Herceptin and Perjeta, which have the approval of the FDA. However, Eckler argues that even if it’s approved, Aphinity’s benefit will not have much significance. Instead, Herceptin plus Perjeta will have a wider preference.
Puma’s new drug comes at a time when the market is struggling with dissatisfied patients over unmet needs. A majority of them cannot access proper health care for lack of treatment options.
Puma Biotechnology has been at the forefront of developing and commercializing products, which are primarily for the treatment of cancer. However, neratinib also happens to be the company’s only lead given that it is yet to embrace an approved product in its portfolio.
In the meantime, Puma’s stock closed at $38.50 witnessing an increase of $2.25 or 6.21%.