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DYAX Analysis & Videos »
DYAX: Bull or Bear?
BioMed News Bytes: Aldagen, Dyax, HGSI
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+13.00%
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25 days
The <font> BioMedReports.com FDA Calendar service </font> includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. <> On 6/8/09, Dyax Corp. (NASDAQ: DYAX) announced today that the FDA accepted the Co...
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FDA Calendar Updates: KG, PTIE, DRRX, ALTH, TRIB, CBST, DYAX
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+9.21%
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113 days
(closed on 10/28/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 243 entries as of 7/7/09. 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 pending...
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BioMedReports FDA Calendar: Seven Laggard Trades
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+2.49%
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4 days
(closed on 06/21/09)
Below are seven companies from the <font> BioMedReports.com FDA Calendar </font> database of over 200 entries, which have pending new drug decision(s) at the FDA combined with a stock price that is below its 200-day moving average (200-DMA). The list includes a balanced mix of two large-caps, two mid-caps, and three small-cap stocks which have been laggards in the overall market rally with looming regulatory catalysts in the form of FDA new drug decisions serving as potential upside catalysts. Data Source: Yahoo! Finance on 6/17/09 during late day trading. <> <font> <>http...
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FDA Calendar Updates: MITI, KERX, GSK, DYAX, ARNA, PGNX
DYAX
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-5.63%
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9 days
(closed on 06/17/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of about 200 entries. 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 pending late-s...
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FDA and Clinical Trial Calendar Updates
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-20.88%
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73 days
(closed on 06/08/09)
<> 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 106 entries through 3/27/09. The FDA Calendar includes the following information: company name...
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FDA and Clinical Trial Calendar Updates
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+7.11%
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2 days
(closed on 03/27/09)
FDA and Clinical Trial Calendar Updates <> 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 106 entries through 3/25/09. The FDA Calendar includes the fo...
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Trading FDA Decisions: 14 Extreme Trades
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+16.39%
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14 days
(closed on 03/25/09)
Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent. http://biomedreports.com/blog/Trading-FDA-Decisions-14-Extrem... <> <> Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary a...
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FDA Calendar: New Entries, One-Week Outlook
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-7.09%
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33 days
(closed on 03/11/09)
FDA Calendar: New Entries, One-Week Outlook The table at my website link below includes 84 pending FDA new product decision dates. Click here for a link to my previous calendars and here for 16 extreme FDA trades of companies with market caps below $150M with pending decisions. New Entries on the FDA Calendar: <> 1.) Acorda Therapeutics (ACOR): ACOR filed a NDA for Fampridine-SR Oral Tablet to improve the walking ability of people with multiple scleros...
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FDA Calendar: Two Advisory Panel Meetings
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-21.18%
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3 days
(closed on 02/06/09)
FDA Calendar: Two Advisory Panel Meetings By Mike Havrilla on 2/3/09 ETF Innovators The tables at my website link below feature an updated calendar of 79 expected FDA new product decisions and 91 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars. <> 1.) Eli Lilly (LLY) and Daiichi Sanky (DSKYY) have a FDA advisory panel meeting today to review their potent...
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Emerging Biotech & Pharma Index: 36 More Companies
DYAX
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+37.10%
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71 days
(closed on 02/03/09)
<> 
The accompanying table [click to enlarge or download] includes the 36 remaining companies in the ETF Innovators [ETFI] Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff.
However, several of the companies included in the remaining group of 36 have been in the news recently due to FDA related news . Late last week, Ligand Phar...
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