Timeframes Moved Forward as OREX Light Study Continues Enrollment Faster Than Anticipated
Orexigen Therapeutics (NASDAQ:OREX) continues this week’s gains in early trading on Thursday, up roughly 20% to $5.35 since Tuesday. The strength comes from Orexigen’s announcement that its Phase III safety trial of the weight-loss drug Contrave is enrolling much faster than anticipated. Orexigen expects to close enrollment in the fourth quarter of this year; the company announced similar news in July and bumped guidance for enrollment closure to early 2013. The trial is measuring Contrave patients for major adverse cardiovascular events (MACE) but management is unsure when interim data will be available; rapid enrollment should speed up the process. Contrave’s New Drug Application (NDA) was met with a Complete Response Letter from the FDA in 2011, but Orexigen may resubmit the NDA after interim data from the Light Study. The trial has 4,500 patients enrolled and is expected to have a total of 10,000 patients. Contrave is the third weight-loss drug under recent consideration since the approval of Vivus’ (NASDAQ:VVUS) Qsymia, and Arena’s (NASDAQ:ARNA) Belviq. Some of PropThink’s previous articles on these weight-loss drugs are available here and here
Expect the company to continue updates into the end of the year, which should in turn drive shares higher and may offer a swing trade opportunity, as evidenced by stock movement after the July 11 update. The news this week is the second announcement in three months pertaining to faster enrollment in the Light Study.