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BioMed News Bytes: Arena (NASDAQ: ARNA), Momenta (NASDAQ:MNTA), Vivus (NASDAQ: VVUS)
VVUS
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-24.51%
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79 days
<> On 9/18/09, Arena Pharma (NASDAQ: ARNA) ($5.32, +9%) (heavy, above-average volume) announced lorcaserin met all primary endpoints and FDA benchmark with 63% of patients who complied with the protocol losing at least 5% of their weight. ARNA plans to file a NDA with the FDA in December. However, patients who took lorcaserin 10 mg twice daily achieved an average weight loss of 5.9% of their body weight, compared to 2.8% for placebo, causing shares of ARNA to initially decline on the news (with a recent turnaround and uptick) based on concerns for the commercial prospects of lorcaserin compar...
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FDA Calendar: Five Weight Loss Trades
VVUS
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+72.81%
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59 days
(closed on 09/18/09)
<> Below are five small/micro-cap companies from the <font> BioMedReports.com FDA Calendar </font> with late-stage drugs or medical devices in development for prescription weight loss. Nearly two-thirds or 65% of U.S. population is classified as obese or overweight with a three-fold increase in adolescent obesity rates over the past three decades. Obesity is the second leading cause of preventable deaths behind smoking and weight loss is proven to decrease mortality while also improving blood sugar control in diabetics. Over one-third (35%) of people in the U.S. have a lifetime of devel...
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Extreme FDA Calendar Trades: 18 Stocks Under $5
VVUS
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+14.07%
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18 days
(closed on 07/21/09)
<> Below are extreme trades among companies with stock prices under $5 from the <font> BioMedReports.com FDA Calendar </font> , which includes 232 entries as of 7/3/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissio...
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NeuroSearch Experimental Obesity Drug to Begin Phase 3 Trials
VVUS
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+5.17%
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24 days
(closed on 07/03/09)
<> As a trio of U.S. small-cap drug makers await crucial Phase 3 results later this year; NeuroSearch (CPH:NEUR) (PINK:NEUSF) is preparing to advance its own experimental weight loss drug to the final stage of clinical development following a successful End of Phase 2 meeting with the FDA which was announced earlier this week. Arena Pharma (NASDAQ:ARNA), Vivus (NASDAQ:VVUS), and Orexigen Therapeutics (NASDAQ:OREX) are all awaiting Phase 3 clinical trial data expected during 3Q09 for their experimental weight loss drugs to support NDA filings for FDA approval, which are summarize...
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FDA, Clinical Trial Calendars: Nine Cash Plus Catalyst Trades
VVUS
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+26.07%
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31 days
(closed on 06/09/09)
Below are nine 'Cash Plus Catalyst' trades which include companies that are currently trading for around 2X net cash/equivalents or less (the ratio of market cap to cash/equivalents less debt) with pending FDA decisions, clinical trial results, or pending FDA submissions. <font> Click here for a link </font> to the BioMedReports FDA and Clinical Trial Calendars page. <> 1.) BioForm Medical (NASDAQ:BFRM) : Market Cap = $59.8M, Net Cash = $41.4M. In March 2009, BioForm Medical announced the results of a clinical trial evaluating the mixing of lidocaine with RADIESSE derma...
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From the Blogosphere
Zacks Analyst Blog Highlights: Clorox Company, Arena Pharmaceuticals, Vivus Inc., Orexigen Therapeutics and Amylin Pharmaceuticals – Press Releases
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For Immediate Release Chicago, IL – November 3, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Clorox Company (CLX), Arena Pharmaceuticals (ARNA), Vivus Inc. (VVUS), Orexigen Therapeutics (OREX) and Amylin Pharmaceuticals (AMLN). Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513 <><>Here are highlights from Monday’s An<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>< />< />< />< /><><><><>< /><><>< /><>< /><>< />< />...
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Amylin Strikes First on Obesity – Analyst Blog
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Almost all of the news in the obesity race has been made recently by three small biotech companies -- Arena Pharmaceuticals (ARNA), Vivus Inc. (VVUS) and Orexigen Therapeutics (OREX), but yesterday it was mid-cap Amylin Pharmaceuticals (AMLN) that signed the first partnership in what was originally perceived to be a three-horse race.
Amylin and Takeda Pharmaceutical Company Limited entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pramlintide/metreleptin and davalintide, two phase II compounds for the treatment of obesi...
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Google Venture Capital Fund Invests In Biotech
Google's (GOOG) venture capital fund, Google Ventures, is investing an amount rumored to be around $10 million in Adimab, a biotech firm, Andrew Pollack reports for the New York Times.
Adimab has developed a new method for generating protein-based drugs, and has already struck deals with drug-makers Merck (MRK) and Roche (RHHBY) to use the process.
Read the rest of this story » See Also:
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Vivus: A One Trick Pony
Well, Vivus's (VVUS) long-awaited one-year pivotal data for weight-loss drug Qnexa, released September 9, was great, all agree. There is a PowerPoint presentation on their web site and a slew of new articles anywhere you care to look. Placebo-adjusted, patients reached on average 11% weight loss on the higher dose of Qnexa and 5.1% on the low dose. In fact, even the low dose was so efficacious not only in terms of weight loss, but also in terms of secondary endpoints (metabolic and cardiovascular improvement) that VVUS plans to submit all three doses for approval to the FDA. <>Obviously, ...
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Vivus's Qnexa Drug Approval Makes It a Nice Trade
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Here are Wednesday's articles concerning Vivus Inc's (VVUS) FDA approval for Qnexa. I see this as a blockbuster drug candidate and good news for the nearly 40M Obese Americans. My only caution is later health problems as it uses some form of the fen-phen medication. This is a nice trade right now and in the future. Watch out Alli, Glaxo (GSK) Consumer Health's obesity drug, here Vivus comes. Glaxo's alli just received health concerns recently over liver failure. In addition to Qnexa, Vivus also has various Phase III clinical trials for the ED medication Avanafil due Oct 2009, with a long te...
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