Puma Biotechnology, Inc.’s (PBYI - Free Report) marketing authorization application (“MAA”) for neratinib is one step closer to approval. The company announced that the Committee for Medicinal Products for Human Use (“CHMP”) has adopted a positive trend vote recommending the approval of neratinib in Europe.
The MAA is seeking approval of neratinib as extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer. We remind investors that the CHMP had adopted a negative opinion for the same MAA in February. However, upon re-examination, it adopted a positive trend vote this time.
The CHMP will hold a final vote on the approval in its next meeting, following which the European Medicines Agency will take its decision.
Shares of Puma Biotechnology rallied 24% on Jun 26 following the news. However, Puma’s shares have underperformed the industry so far this year. The stock has declined 35.7% compared with the industry’s 7.5% decrease.
We note that neratinib was approved in the United States in July last year in a similar indication in patients who were previously treated with Roche’s (RHHBY - Free Report) Herceptin (trastuzumab)-based adjuvant therapy. The drug is marketed under the brand, Nerlynx.
Nerlynx has shown impressive growth since approval and registered sales of $36 million in the first quarter of 2018, up sequentially. Moreover, the number of prescribers for Nerlynx increased by more than half in that period. A potential approval in Europe will further boost growth.
Meanwhile, Puma Biotechnology is busy signing marketing agreements with several companies for commercialization of the drug in various geographies. These agreements will make availability faster following approval in these geographies.
Breast cancer is the most common form of cancer diagnosed in women, with 20 to 25% of the patients with HER2-positive. Although Herceptin reduces the risk of recurrence of early stage HER2-positive breast cancer after surgery, a quarter of patients experience recurrence. Nerlynx can be a treatment option for these patients.
The company is also developing neratinib in several studies as monotherapy or in combination targeting different types of breast cancer patient populations and in other settings.
Zacks Rank & Stock to Consider
Puma Biotechnology currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A couple of better-ranked stocks from the same space are Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy).
Aeglea’s loss per share estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 101.3% so far this year.
ANI Pharmaceuticals’ earnings per share estimates moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 3.9% so far this year.
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