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orexigen therapeutics inc (OREX) Key Developments

Orexigen Therapeutics, Inc. Presents at Bank of America Merrill Lynch Global Healthcare Conference, Sep-18-2014 04:10 PM

Orexigen Therapeutics, Inc. Presents at Bank of America Merrill Lynch Global Healthcare Conference, Sep-18-2014 04:10 PM. Venue: Bank of America Merrill Lynch Financial Centre, London, United Kingdom.

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen(R) Therapeutics, Inc. Announce FDA Approval of Contrave Extended-Release Tablets for Chronic Weight Management

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen(R) Therapeutics, Inc. jointly announced that the U.S. Food and Drug Administration (FDA) has approved Contrave(R) (naltrexone HCI and bupropion HCI) 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 (BMI) of 30 kg/m(2) or greater (obese), or 27 kg/m or greater (overweight) in the presence of at least one weight-related comorbid condition. Contrave is an important addition to Takeda's portfolio of cardiometabolic products. Takeda is committed to providing patients with obesity with treatment options that help address their needs, and the company is planning to commercially launch Contrave in the fall of 2014. The effect of Contrave on cardiovascular morbidity and mortality has not been established. In addition, the safety and effectiveness of Contrave in combination with other medications intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. The exact neurochemical effects of Contrave to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system). CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients. Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although CONTRAVE is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur. Contraindications: CONTRAVE is contraindicated in patients with uncontrolled hypertension, seizure disorder, or current or prior diagnosis of anorexia nervosa or bulimia; in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; with use of other bupropion-containing products; for use with chronic opioids or opiate agonists (eg, methadone) or partial agonists (eg, buprenorphine) or acute opiate withdrawal; during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); in patients with known allergy to any other component of CONTRAVE--anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; in pregnancy. Warnings and Precautions: Suicidal Behavior and Ideation: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy or at times of dose changes, either increases or decreases. Consider changing the therapeutic regimen or discontinuing in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, or mania, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Alert families and caregivers of patients being treated with antidepressants about the need to monitor patients for the emergence of above mentioned symptoms, as well as the emergence of suicidality, daily and to report such symptoms immediately. Prescriptions for CONTRAVE should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose. Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment: CONTRAVE is not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation, including changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur. Seizures: CONTRAVE can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution and consider the risk when prescribing CONTRAVE to patients with predisposing factors, clinical situations, and concomitant medications that may lower seizure threshold. Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding co-administration with a high-fat meal. Patients Receiving Opioid Analgesics: CONTRAVE should not be administered to patients receiving chronic opioids. Patients may be vulnerable to opioid overdose and/or precipitated opioid withdrawal. Increase in Blood Pressure (BP) and Heart Rate (HR): CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. Monitor BP and HR especially in patients with cardiac or cerebrovascular disease and/or with controlled hypertension.

Orexigen Therapeutics, Inc. - Special Call

Orexigen Therapeutics, Inc. - Special Call

Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited Enter into Manufacturing Services Agreement

In preparation for the potential launch of NB32, Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited (Takeda) entered into a Manufacturing Services Agreement, dated September 2, 2014, in accordance with the collaboration agreement between the company and Takeda, effective as of September 1, 2010, as amended by amendment number 1 to collaboration agreement effective as of September 26, 2013. Pursuant to the agreement, among other things, the company will supply to Takeda, and Takeda will, subject to certain exceptions as set in the agreement and collaboration agreement, exclusively purchase from the company, all of Takeda’s requirements of NB32 for commercialization in the United States, Canada and Mexico during the term of the collaboration agreement. The agreement will continue in full force and effect until the expiration or termination of the collaboration agreement. Notwithstanding the foregoing, the agreement will also terminate automatically (prior to the expiration or termination of the collaboration agreement) upon (1) the completion of the transfer of the right and responsibility to manufacture or have manufactured NB32 to Takeda pursuant to the collaboration agreement and (2) if elected by Takeda, the assignment to Takeda of all of the third party manufacturer agreements required for the manufacture of NB32 in the applicable territory.

Orexigen Therapeutics, Inc. Reports Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2014

Orexigen Therapeutics, Inc. reported unaudited earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported total revenues of $857,000 against $857,000 a year ago. Loss from operations was $22,802,000 against $18,263,000 a year ago. Net loss was $24,507,000 against $18,246,000 a year ago. Basic and diluted net loss per share was $0.21 against $0.19 a year ago. For the six months, the company reported total revenues of $1,714,000 against $1,714,000 a year ago. Loss from operations was $45,956,000 against $37,661,000 a year ago. Net loss was $49,405,000 against $37,614,000 a year ago. Basic and diluted net loss per share was $0.43 against $0.41 a year ago.

 

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