Key Developments: Orexigen Therapeutics Inc (OREX.OQ)
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Latest Key Developments (Source: Significant Developments)
The Law Firm of Levi & Korsinsky, LLP Launches An Investigation Into Possible Breaches Of Fiduciary Duty By The Board Of Directors Of Orexigen Therapeutics Inc
Levi & Korsinsky, LLP announced that it is investigating Orexigen Therapeutics Inc and its Board of Directors, in connection with possible claims of breaches of fiduciary duty. Full Article
Orexigen Therapeutics Inc Prices Public Offering Of Common Stock
Orexigen Therapeutics Inc announced that it has priced an underwritten public offering of 11,000,000 shares of its common stock at a price of $5.50 per share. Net proceeds, after underwriting discounts and commissions and estimated expenses, will be approximately $56.5 million. Orexigen has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock. The offering is expected to close on or about October 30, 2012, subject to satisfaction of customary closing conditions. Credit Suisse Securities (USA) LLC, BofA Merrill Lynch and Leerink Swann LLC are acting as joint book-running managers for the offering. Full Article
Orexigen Therapeutics Inc Announces Proposed Public Offering Of Common Stock
Orexigen Therapeutics Inc announced that it intends to offer shares of its common stock in an underwritten public offering. In connection with this offering, Orexigen expects to grant to the underwriters a 30-day option to purchase additional shares of common stock. All of the shares are being offered by Orexigen. Credit Suisse Securities (USA) LLC, BofA Merrill Lynch and Leerink Swann LLC are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
Orexigen Therapeutics, Inc. Reports Enrollment Trend In Contrave Study-DJ
Dow Jones reported that Orexigen Therapeutics, Inc. expects to complete enrollment in an interim study of cardiovascular risks associated with its weight loss treatment Contrave in the first quarter next year, potentially reducing its initial estimates by half. Orexigen had suspended U.S. development of Contrave last year after regulators asked it to conduct additional clinical tests that the company said were unnecessary. But the company renewed its development when the Food and Drug Administration in September said it could approve Contrave if an interim analysis meets specified criteria on cardiovascular risk. The company said since early June that more than 1,500 patients with the targeted risk profile had been enrolled at about 100 clinical trial sites. Orexigen said it plans to have an additional 200 test sites on line by the end of next month. The company said as a result of the revised enrollment projections, it could potentially be ready to conduct its interim analysis in the second half of next year. Orexigen plans submit its application for FDA approval if interim analysis allows the company to exclude a doubling of risk of cardiovascular events in patients receiving Contrave compared with a placebo. Full Article
Orexigen Therapeutics, Inc. Completes Public Offering Of Common Stock And Warrants To Purchase Common Stock
Orexigen Therapeutics, Inc. announced the completion of its public offering of 5,646,173 units. Each unit consisted of one share of common stock and a warrant to purchase ten shares of common stock, at a price to the public of $1.45 per share of common stock and $1.449 per warrant to purchase each share of common stock, which together comprised the purchase price of $15.94 per unit. Net proceeds, after underwriting discounts and commissions and estimated expenses, were approximately $86.9 million. The underwriter does not have an option to purchase any additional units in this offering. Leerink Swann LLC acted as sole manager for the offering. Full Article
Orexigen Therapeutics, Inc. Prices Public Offering Of Common Stock And Warrants To Purchase Common Stock
Orexigen Therapeutics, Inc. announced that it has priced an underwritten public offering of 5,646,173 units. Each unit consists of one share of common stock and a warrant to purchase ten shares of common stock, at a price to the public of $1.45 per share of common stock and $1.449 per warrant to purchase each share of common stock, which together comprise the purchase price of $15.94 per unit. Net proceeds, after underwriting discounts and commissions and estimated expenses, will be approximately $86.9 million, excluding the proceeds, if any, from the exercise of the warrants issued pursuant to this offering. The underwriter will not have an option to purchase any additional units in this offering. The offering is expected to close on or about December 22, 2011, subject to satisfaction of customary closing conditions. Leerink Swann LLC is acting as sole manager for the offering. Full Article
Orexigen Therapeutics, Inc. Announces Proposed Public Offering Of Common Stock
Orexigen Therapeutics, Inc. announced that it intends to offer units in an underwritten public offering, with each unit consisting of one share of Orexigen's common stock and a warrant to purchase a certain number of shares of Orexigen's common stock. In connection with this offering, Orexigen expects to grant to the underwriter a 30-day option to purchase additional units to cover overallotments, if any. All of the units are being offered by Orexigen. Leerink Swann LLC is acting as sole book-running manager for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
Orexigen Therapeutics, Inc. Presents Multiple Contrave Data Presentations At The 29th Annual Scientific Meeting of The Obesity Society
Orexigen Therapeutics, Inc. announced that Contrave (naltrexone SR/bupropion SR) data will be presented in one oral and multiple poster presentations at the 29th Annual Scientific Meeting of The Obesity Society on October 3, 2011 in Orlando, FL. The Company will present results from evaluations of the COR (Contrave Obesity Research) program data for predicted long-term outcomes as well as responder analyses of Contrave treatment. Additionally, Orexigen will present results of a recently completed clinical trial assessing the impact of Contrave on certain neurobiological mechanisms that control the brain's response to food cues. A presentation led by Robert Chilton, DO, FACC, Professor of Medicine at the University of Texas Health Science Center at San Antonio, will discuss the impact of Contrave treatment on predicted 10-year cardiovascular (CV) outcomes as estimated using 1-year data from the Phase 3 COR program. Multiple validated models utilizing different methodologies for evaluating CV risk were used to predict the long-term risk of CV disease, CV mortality, myocardial infarction and stroke with Contrave or placebo treatment. A statistically significant three-fold reduction in predicted 10-year overall CV risk was observed with Contrave treatment compared to placebo. These results are useful in predicting the potential impact of long-term treatment with Contrave and provide the Company with confidence in proceeding with the planned CV outcomes clinical trial. Full Article
Orexigen Therapeutics, Inc. And FDA Identify Clear And Feasible Path to Approval for Contrave
Orexigen Therapeutics, Inc. announced that following a recent meeting with senior officials in FDA's Office of New Drugs (OND), the Company received written correspondence detailing OND's design requirements for a cardiovascular outcomes trial (CVOT) for Contrave that would address the Complete Response Letter (CRL) received in January 2011 . Orexigen believes that these design requirements are reasonable and feasible and provide the certainty required to reinitiate development of Contrave. Importantly, FDA stated that "if the interim analysis meets the specified criteria to exclude an unacceptable increased cardiovascular (CV) risk, the drug could be approved. Full Article

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