Tag archive for ‘Orexigen Therapeutics’
Contrave Is Given New Life as FDA Reverses its Position on Design of Cardiovacular Outcomes Trial (OREX, $2.45)
Investment Opinion Orexigen’s (OREX) anti-obesity drug Contrave has been given new life as the FDA reversed a previous position that would have required a cardiovascular outcomes trial involving 60,000 to 100,000 patients and which might have taken four to six years to complete in order to gain US approval for Contrave. In a press release […]
Orexigen Revisited: Chances for Contrave Approval Seem Slim (OREX, $1.37)
Orexigen reported second quarter results on August 8, 2011 in a press release, but did not hold a conference call. The CEO of the company, Mike Narachi, stated that the company is continuing the dispute resolution process with the FDA to try to reach an agreement on identifying a patient population for its anti-obesity drug […]
Orexigen Therapeutics (OREX)
The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s Contrave, Vivus Qnexa and Arena’s Lorques. All three drugs received complete response letters following their NDA submissions and the companies are in the process of addressing the FDA’s concerns before refilling their NDAs.The potential for Contrave approval in the US is […]
Orexigen Receives Crushing News That FDA Will Require Extremely Large Cardiovascular Outcomes Study In Order for Contrave To Gain Approval (OREX, $1.83)
Stock Opinion The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17, VVUS) Qnexa and Arena’s ($1.38, ARNA) Lorques. All three drugs received complete response letters following their NDA submissions and the companies are in the process of addressing the FDA’s concerns before refilling their NDAs. […]
Company Reports Success in Four Phase III Trials (OREX, $4.23)
Orexigen has just reported success in four phase III trials for Contrave in obesity. Contrave Overview The key efficacy measure in these trials was that ≥ 35% of patients on the drug lose at least 5% of body weight and that the proportion is double placebo or that mean weight loss is ≥ 5% difference […]
Going Over the Outlook with the New CEO, Mike Narachi (OREX, $5.32)
I have met numerous times with CFO, Graham Cooper. This was an opportunity to meet with the new CEO, Michael Narachi, who comes from Amgen. I am extremely impressed by his operational expertise and strategy. He should be an excellent CEO to lead the company into its commercial phase. Overview I am of the opinion […]
Thoughts on Upcoming Advisory Meeting on Contrave (OREX, $5.40)
On December 3, 2010, an FDA advisory panel will review the NDA submitted by Orexigen Therapeutics for its new anti-obesity agent Contrave. This note previews and discusses possible issues that the panel will address. Introduction Their recommendation to the FDA as to whether Contrave should be approved obviously will have dramatic consequences for Orexigen’s stock. […]