As #PumaBiotechnology $PBYI nears an FDA advisory panel meeting for its breast cancer treatment candidate #neratinib, #Citi argues that a recent hiring push by Puma signals its confidence in securing approval, an event which the research firm says could send shares soaring by 100% or more.
BACKGROUND: The FDA has scheduled a May 24 Advisory Committee meeting for Puma’s neratinib in extended adjuvant treatment of “HER2” early stage breast cancer. In its Q1 earnings report last night, the company confirmed that “we look forward to presenting” at the May 24 meeting. #HER2
CITI SEES POTENTIAL DOUBLE: In a post-earnings research note, Citi’s analyst highlights that Puma accelerated plans for final five-year data from the ” #ExteNET ” neratinib trial to Q2 from the second half, as it will be used during the drug’s May 24 #AdComm. The analyst confirmed with Puma that additional data from the “CONTROL” prophylactic trial will also be presented at the meeting.
Notably, the analyst says he “noticed” that Puma appears to be actively hiring for commercial operations, with the company’s website now showing 18 job listings for roles within outreach, commercial supply chain, market access, reimbursement, and other areas. Though critics may interpret the news as signaling that Puma doesn’t expect to be acquired, the analyst counters that such an argument “doesn’t work too well tactically,” as the stock should gain at least 100% on what he calls an “expected positive” AdComm.
Indeed, the analyst views the hiring push as “obviously reflecting confidence” in approval while both maximizing future sales potential and remaining open to future strategic options, with the analyst reminding investors that Puma CEO Alan Auerbach successfully sold his last company to big pharma.
PRICE ACTION: Shares of Puma Biotechnology are up fractionally to $30.75 in afternoon trading.
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