Puma Biotechnology, Inc. 's PBYI shares gained 10.5% after the company announced that its New Drug Application (NDA) for its lead candidate, neratinib (PB272), has been accepted for review by the FDA.
The company is looking to get neratinib approved as an extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, who have been previously treated with Roche Holding AG's RHHBY
Herceptin (trastuzumab)-based adjuvant therapy.
In Jul 2016, Puma Biotech submitted the regulatory application based on results from a phase III (ExteNET) study, which demonstrated a statistically significant reduction (33%) in the risk of invasive disease recurrence or death, in comparison to placebo.
We remind investors that last month, the company's Marketing Authorisation Application (MAA) for neratinib was validated by the European Medicines Agency (EMA).
PUMA BIOTECHNLG Price
PUMA BIOTECHNLG Price | PUMA BIOTECHNLG Quote
Currently, neratinib is in several breast cancer studies. Data from these studies are expected in the second half of 2016 and beyond. Although the company is exploring the possibility of developing an intravenous formulation of neratinib, it is currently focused on an oral formulation of the candidate.
Puma Biotech believes that neratinib can also be developed for the treatment of other types of cancers, including non-small cell lung cancer (NSCLC) and other tumor types that over-express or have a mutation in HER2.
We note that the breast cancer market is heavily crowded with drugs like Faslodex, Ibrance, Herceptin and Femara among others.
With no approved product in the company's portfolio and neratinib being its lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development. A potential approval will enable the company to generate product revenues for the first time.
Puma Biotech currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector are Anika Therapeutics, Inc. ANIK and ANI Pharmaceuticals, Inc. ANIP . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report ANIKA THERAPEUT (ANIK): Free Stock Analysis Report PUMA BIOTECHNLG (PBYI): Free Stock Analysis Report ANI PHARMACEUT (ANIP): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research