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Achillion Pharma: Funding in Place to Advance HCV Pipeline
GSK
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<> Achillion Pharma (ACHN) is a promising micro-cap biotech, specializing in the development of new treatments for infectious diseases, such as the multi-billion dollar market for the chronic treatment of hepatitis C. As I recently wrote , several companies in this space have been bought out at huge premiums over the past year – including an astounding premium of over 400% for a $57M buyout by GlaxoSmithKline (GSK) of hepatitis C virus [HCV] developer Genelabs (GNLB).
Since completing a $41.5M private place...
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Updated FDA Calendar of 73 Decision Dates
GSK
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<> 
The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).
An FDA panel voted against Targanta's oritavancin, which has an upcomin...
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Updated FDA Calendar of Decision Dates
GSK
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<> 
The accompanying table of FDA decision dates is updated to include the following: 1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK); 2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09; 3) Genentech (DNA) filed for accelerated approval of Avastin as a s...
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A Backlog of Decisions is Building at the FDA
GSK
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<> 
The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices.
Disco...
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Full FDA Calendar of Decision Dates
GSK
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<> The accompanying table presents a full FDA calendar of decision dates updated through today, which I will maintain at the bottom of my blog in place of the previous Global Carbon Trading Index. Click on the calendar image above or on my blog to view or download the PDF version of the FDA calendar, which I will also maintain at: www.geocities.com/mikehavrx/fdac.pdf .
Several key decisions are pending through the end of this month for the group of 14 big pharma companies I outlined yesterday, including Eli Lilly (L...
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