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OREX Analysis & Videos »
OREX: Bull or Bear?
FDA Calendar: Five Weight Loss Trades
OREX
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-6.12%
in
110 days
<> 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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FDA Calendar Updates: DDSS, HGSI, OREX, SPPI, TRIB
OREX
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+16.06%
in
1 day
(closed on 07/21/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 263 entries as of 7/20/09. 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-submissions to the FDA, and pendin>...
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Extreme FDA Calendar Trades: 18 Stocks Under $5
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-14.28%
in
17 days
(closed on 07/20/09)
<> 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
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-44.64%
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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 summarized and tracked >...
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FDA, Clinical Trial Calendar Updates: Weight Loss, Diabetes, and More
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-13.20%
in
43 days
(closed on 05/14/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 110 entries through 4/1/09. The FDA Calendar includes the following information: company name, ticker, decision d>...
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A Calendar of Expected Clinical Trial Results
OREX
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-50.40%
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80 days
(closed on 04/01/09)
<> The accompanying table [click to enlarge] includes 58 entries of expected clinical trial results in addition to pending FDA applications for new product approvals + a list of companies which will be required to re-submit their applications due to complete response letters from the agency. See my recent article on 20 emerging healthcare stocks to watch in 2009 for more details on some of the companies included in the accompanying calendar, in addition to the following companies with near-term catalysts in>...
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