J.P. Morgan analyst Cory Kasimov weighed in today on shares of Puma Biotechnology Inc (NYSE:PBYI), following the news that the FDA has accepted the company’s new drug application (NDA) for its lead asset, neratinib, in the extended adjuvant setting of HER2+ breast cancer. Puma Biotechnology shares reacted to the news, rising over 10%.
Kasimov commented, “We saw the acceptance as an important step for Puma and neratinib given the back and forth that has occurred between the company and the agency on the filing package over the past ~2 years. Anecdotal observation from our trading desk noted quite a bit of put buying on concerns that FDA would delay the process another time, which is consistent with our investor conversations and current Bloomberg short interest ~19%.”
“Although acceptance is now in the rearview mirror, we still have a few outstanding questions regarding the time for review and whether an ODAC will be convened. With nothing specified in the press release, we assume that neratinib will be under a standard, rather than priority, review (placing a decision in ~10 months) and that an advisory committee will be convened during the review period,” the analyst added.
Kasimov maintained an Overweight rating on PBYI stock, with a price target of $89, which represents a potential upside of 35% from where the stock is currently trading.
As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Cory Kasimov has a yearly average return of -11.2% and a 32% success rate. Kasimov has a 13.4% average return when recommending PBYI, and is ranked #4029 out of 4166 analysts.
Out of the 5 analysts polled by TipRanks (in the past 3 months), 4 rate PBYI stock a Buy, while 1 rates the stock a Hold. With a return potential of nearly 14%, the stock’s consensus target price stands at $74.25.