Posts Tagged ‘orex’

Orexigen Therapeutics, Inc. (OREX) surges on news of obesity drug revival

Wednesday, September 21st, 2011

Shares of Orexigen Therapeutics, Inc. (Nasdaq: OREX) surged more than 80 percent from Tuesday’s closing price in morning trading on Wednesday after the company, along with the U.S. Food and Drug  Administration identified “a clear and feasible path to approval for Contrave,” Orexigen’s experimental obesity drug that was shelved  earlier this year because of health risks.

“We have been working with clinical experts, advocacy groups, and our partner, Takeda, throughout this process and are pleased with the feedback provided by FDA that identified a very clear and feasible path forward for this important therapy,” said Michael Narachi, President and CEO of Orexigen in a September 21 press release.

Shares of Orexigen touched a high of $2.68, up from Tuesday’s closing price of $1.47, according to Yahoo Finance.

Contrave, an investigational combination therapy of naltrexone HCl and bupropion HCl, was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year. Contrave was submitted for U.S. regulatory approval in March 2010. The original submission was based on multiple clinical trials that evaluated Contrave in more than 4500 patients.

Orexigen Therapeutics and its Japanese partner Takeda will need to run a  patient safety study of approximately 10,000-patients to assess the heart-safety risk of Contrave.

Orexigen estimates that the entire study would require less than 10,000 patients and less than two years from study start to the interim analysis, according to the September 21 press release. Orexigen plans to meet with the review division to finalize a protocol with the objective of initiating the CVOT in the first half of 2012, with potential approval in 2014.

Orexigen Therapeutics Inc. (OREX) stock price balloons for diet pill maker

Wednesday, June 1st, 2011

Orexigen Therapeutics Inc. (Nasdaq: OREX) shares jumped 17.7% to $3.33 Wednesday, after the diet-pill developer said it would make a regulatory announcement about its obesity treatment in two days. Volume for the stock was 8.2 million shares, or more than six times its daily average.

The San Diego-based Orexigen has announced a regulatory update on Friday, June 3, before the markets open. The announcement will be followed by a live webcast and conference call at 8:00 a.m. Eastern time. No one from Orexigen management was immediately available for comment.

The company’s lead product, Contrave®, has completed Phase 3 clinical trials and has received a Complete Response Letter from the FDA for its New Drug Application. The Company is in the process of determining the next steps for Contrave.

The Company’s second product, Empatic™, has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches.

OREX jumps, MU popular, FFBH falters

Monday, January 31st, 2011

Orexigen Therapeutics Inc. (Nasdaq: OREX) shares were up 8.4 percent to $9.02, on volume of 4.9 million, towering over a daily average of 2.8 million, as a regulatory decision was expected Monday on its diet pill.

Micron Technology Inc. (Nasdaq: MU) traded in 26.9 million shares, trailing its daily volume of 35.8 million. Prices for the stock increased 1.5 percent to $10.53, after Sterne Agee & Leach raised its price target to $17 from $12. Sterne continues to rate MU at Buy.

First Federal Bancshares of Ark (Nasdaq: FFBH) shares fell 12.2 percent to $2.15, on volume of 123,318 shares, eight times its daily average. The small southwestern bank announced a recapitalization plan that will allow an investment group to buy up to $55 million of common stock, diluting shareholders.

DNN gains ground, MOT sells widely, OREX falters

Wednesday, December 1st, 2010

Denison Mines Corp. (AMEX: DNN) climbed in price 7.42 percent to $3.33 early Wednesday afternoon. Volume was 4,929,037 shares, twice-and-a-half its normal daily volume.

Motorola Corp. (NYSE: MOT) proved quite the popular stock early Wednesday, trading in 33,997,244 shares, its normal share average around 25,960,500 for a full day. Shares in the electronics maker improved 5.55 percent to $8.09. Motorola said late Tuesday that it will split into two entities in January; Motorola Mobility Holdings, including the mobile phone and television set-top box operations, and Motorola Solutions, which will include other communications devices used in government and industry, like bar-code scanners and walkie-talkies.

Orexigen Therapeutics Inc. (NasdaqGM: OREX) fell in price 9.25 percent to $4.71. Volume of 1,798,407 shares nipped ahead the stock’s full-day average. The San Diego-based company brings its weight-loss drug Contrave to an FDA panel next week

Arena Pharmaceuticals, Inc. (ARNA) – Buzz Stock of the Day

Friday, July 16th, 2010

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We first featured Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) on July 1, after the company announced a U.S. marketing deal for its obesity treatment, lorcaserin. Since then, shares have continued their climb, surging almost 20 percent in pre-market trading on Friday after it was announced that an FDA panel voted 9-7 against clearing a competing experimental weight loss drug developed by Vivus, Inc. for marketing in the U.S.

Panelists unanimously agreed the drug helps patients lose pounds, with most reporting more than 10 percent weight loss. But those benefits were outweighed by a slew of safety concerns that cropped up in company trials, including memory lapses, suicidal thoughts, heart palpitations and birth defects.

In contrast, Arena’s weight loss drug, lorcaserin is much safer, but hasn’t shown to shed pounds as much as Vivus’ drug, Qnexa. Lorcaserin is the most advanced candidate in Arena Pharmaceuticals’ pipeline. It is a member of a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor, the company said, is strongly associated with feeding behavior and satiety. The FDA is expected to act on Arena’s application to begin marketing lorcaserin by October 22.

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Shares of Orexigen Therapeutics (Nasdaq: OREX), whose diet drug Contrave is also up for approval, plummeted 12.6 percent to $4.37. Many industry experts believe that while Contrave is safer than Qnexa, its safety profile may not be as strong as Arena’s lorcaserin. Contrave combines the antidepressant Wellbutrin with a sustained-release version of an opioid blocker used to treat alcohol, drug, and other addictions. The company said a late-stage trial of Contrave in patients with type 2 diabetes showed that after 56 weeks of treatment, overweight or obese patients with the disease lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo. Orexigen is up for review in January.

ARNA was recently upgraded to Overweight from Neutral by JP Morgan, with a price objective increasing to $6 from $5. Arena Pharmaceuticals, was also downgraded to Market Underperform from Market Perform by Rodman & Renshaw on Friday morning. The R&R analyst put a paltry $1 price target on the stock, citing efficacy and safety concerns that could present “regulatory challenges” for the firm’s Lorcaserin diet drug.

The market research firm Datamonitor referred to obesity in a 2009 report as the “$11 billion market that never was” as it forecast drug sales in the category to reach just $560 million in 2018, far less that the $12.2 billion market opportunity it says is there. The problem, says Datamonitor, is that “current approaches just aren’t good enough to capitalize on this opportunity.”