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June 11, 2014
06:31 EDTOREXOrexigen receives three month extension of FDA NB32 review
Orexigen announced that the FDA has extended its review of the resubmitted New Drug Application for NB32, the company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act action date has been set for September 11. The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.
News For OREX From The Last 14 Days
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September 18, 2014
10:03 EDTOREXOrexigen management to meet with Leerink
Meetings to be held in New York on September 23 and in Boston on September 24 hosted by Leerink.
September 17, 2014
07:43 EDTOREXBofA/Merrill to hold a conference
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05:51 EDTOREXStocks with implied volatility movement; OREX MNKD
Stocks with implied volatility movement; Orexigen (OREX) 91, MannKind (MNKD) 60 according to iVolatility.
September 12, 2014
16:44 EDTOREXMarket ends week lower as investors fret over Fed statement
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10:35 EDTOREXOptions with decreasing implied volatility
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September 11, 2014
16:21 EDTOREXOn The Fly: Closing Wrap
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12:42 EDTOREXOrexigen falls after FDA requires warnings on Contrave label
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11:07 EDTOREXOptions with decreasing implied volatility
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10:59 EDTOREXArena competition picks up after Contrave approval, says Piper Jaffray
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10:49 EDTOREXHigh option volume stocks
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10:29 EDTOREXOrexigen falls, levels to watch
Trading is volatile on very heavy volume nearing three times the daily average. At the current price of $5.41, next support is at $5.30, the low of the day, and then at $4.60 which is the 52-week low. Resistance is at $5.90, the prior session closing price.
08:01 EDTOREXOrexigen Contrave could have stronger launch than peers, says Wells Fargo
After the FDA approved Orexigen's (OREX) Contrave as a treatment option for chronic weight management, Wells Fargo does not believe the label included any significant surprises. The firm thinks multiple factors increase the chances that Contrave's launch will be stronger than two other weight loss drugs that were launched in recent years by VIVUS and Arena Pharmaceuticals (ARNA). The firm keeps an Outperform rating on Orexigen.
07:06 EDTOREXOrexigen's Contrave weight management tablets approved by FDA
Orexigen Therapeutics and Takeda Pharmaceuticals U.S.A. jointly announced that the FDA has approved Contrave extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index indicating obese or overweight, in the presence of at least one weight-related comorbid condition. Takeda is planning to commercially launch Contrave in the fall.
06:49 EDTOREXFDA approves weight management drug Contrave
The U.S. Food and Drug Administration yesterday approved Contrave as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index of 30 or greater or adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, in an extended-release formulation. The effectiveness of Contrave was evaluated in multiple clinical trials that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. Contrave is distributed by Takeda Pharmaceuticals America (TKPYY) for Orexigen Therapeutics (OREX).
September 10, 2014
18:27 EDTOREXOrexigen trading halted, pending news
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September 9, 2014
15:27 EDTOREXOrexigen volatility elevated
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12:46 EDTOREXNovo Nordisk weight loss drug helped people get thinner, Bloomberg reports
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