Vivus: Consensus Calls For FDA Approval, But Watch For Label Restrictions

PREVIEW: The Prescription Drug User Fee Act (PDUFA) or FDA ‘Action’ date for Vivus’ (NASDAQ:VVUS) obesity drug, Qnexa, is July 17th – an event that’s been widely anticipated by Wall Street and Main Street alike. While the consensus among analysts is that the drug will be approved next week, Vivus shares are likely to trade higher on approval if prescribing restrictions for use are not too onerous. Assuming that, post-approval, Qnexa can be prescribed to patients similarly to Arena’s recently approved obesity drug ‘Belviq’, investors will shift focus to the question of ‘who might acquire Vivus’. Hence, shares could edge higher on speculation of a buy-out. However, IPQ Analytics, an independent research firm, warns that there are “risks that exist which are not currently being factored into expectations” and that the drug may not do as well as analysts are modelling if the drug’s label (prescribing instructions) is more strict than Belviq.