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ALKS Analysis & Videos »
ALKS: Bull or Bear?
FDA, Clinical Trial Calendar Updates: Acorda, Alkermes, GTx
ALKS
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+14.82%
in
218 days
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete r...
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A Calendar of Expected Clinical Trial Results
ALKS
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-24.07%
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102 days
(closed on 04/23/09)
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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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Updated FDA Calendar
ALKS
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+5.25%
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29 days
(closed on 01/11/09)
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week , the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diver...
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Alkermes (ALKS): Buyback boosts biotech
ALKS
-41.92%
in
489 days
Filed under: Newsletters, Stocks to Buy "Alkermes (NASDAQ: ALKS) recently produced a two-pronged positive surprise; an increase in the size of their already existing stock buyback program and a boost in their financial guidance," says John McCamant. In his Medical Technology Stock Letter, the biotech sector expert looks at this firm which focuses on treatments for central nervous system disorders, alcohol depenence, and schizophrenia. Here is his review. <>"Both of these moves were made possible by the announcement that ALKS has received a $40 million payment from Eli Lilly, their former partn...
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Alkermes (ALKS): Buyback boosts biotech bet
ALKS
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-27.91%
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514 days
 "Alkermes (NASDAQ: ALKS) recently produced a two-pronged positive surprise; an increase in the size of their already existing stock buyback program and a boost in their financial guidance," says John McCamant.
In his Medical Technology Stock Letter, the biotech sector expert looks at this firm which focuses on treatments for central nervous system disorders, alcohol depenence, and schizophrenia. Here is his review. <>"Both of these moves were made possible by the announcement that ALKS has received a $40 million payment from Eli Lilly, their former partner for the now defunct AIR Insulin progra...
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Pipeline Issues Keep ALKS a Hold
ALKS
-28.95%
in
526 days
We believe it is subject to heightened risks of additional pipeline failures that may hamper the companyÂ?s progress towards its stated goals.
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