Puma Biotechnology Inc: A European Approval for Neratinib Seems Unlikely

A European approval seems unlikely.

Puma Biotechnology Inc (NASDAQ:PBYI) is down 27% in early trading Wednesday after announcing a disappointing outcome from a meeting with European regulators over its breast cancer drug neratinib.

Read more: Insult to Injury: Puma Biotechnology Gets Analyst Downgrade After EMA Kicked Back Its Breast Cancer Drug

The biotech met with regulators at the European Medicines Agency (EMA) to go over outstanding issues with the marketing application for neratinib, but failed to convince them that the drug is approvable. The “trend” vote that the group of regulators take at the end of the meeting was negative, so it seems unlikely that neratinib will get a positive Committee for Medicinal Products for Human Use (CHMP) opinion when the official decision is made next month.

CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival (iDFS) benefits observed to-date may lack sufficient clinical relevance. As such, additional steps would need to be taken to gain marketing approval in Europe.

On the ratings front, Puma stock has been the subject of a number of recent research reports. In a report released today, Cowen analyst Chris Shibutani downgraded PBYI to Hold, with a price target of $68, which represents a slight upside potential from current levels. Additionally, J.P. Morgan’s Cory Kasimov maintained a Buy rating on the stock and has a price target of $91.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Chris Shibutani and Cory Kasimov have a yearly average return of 26% and 7.1% respectively. Shibutani has a success rate of 61% and is ranked #363 out of 4757 analysts, while Kasimov has a success rate of 46% and is ranked #823.

Overall, 2 healthcare analysts have assigned a Hold rating on PBYI, while 5 have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $113.00 which is 69% above where the stock opened today.

Puma Biotechnology is a development stage biopharmaceutical company. It acquires and develops innovative products for the treatment of various forms of cancer. The company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use.


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