|Celsion HEAT Study Receives Fast Track, Shares Halted; Isis Surges on FDA Approval of KYNAMRO|
|By Staff and Wire Reports|
|Wednesday, 30 January 2013 19:54|
Shares of Celsion (NASDAQ: CLSN) were halted in after-hours trading on Wednesday. The company said it would hold a conference call Thursday morning at 8 am to discuss the top-line results from its Phase III HEAT Study with ThermoDox.
The HEAT Study had received a Fast Track designation from the FDA and Orphan Drug status.
Isis Pharmaceuticals (NASDAQ: ISIS) is up big on Wednesday on the approval of KYNAMRO by the FDA.
On Tuesday, the Carlsbad, California firm announced FDA approval of this cholesterol-fighting drug. Specifically, the drug is used to treat homozygous familial hypercholesterolemia (HoFH), a rare condition that prevents patients from being able to remove LDL or “bad” cholesterol from the blood. And “rare” is not an overstatement, as literally one in a million Americans develops this condition, which often results in heart attacks and death before the age of 30.
One-in-a-Million Drug Earns Isis $25 million--Investors may wonder why the approval of a drug that will only benefit one-millionth of the population has caused this stock to spike. The answer lies in the company's partnership with Genzyme, a Sanofi company (NYSE: SNY).
With the approval of KYNAMRO, Genzyme will pay ISIS $25 million. That's more than double ISIS's total third quarter revenues. Accordingly, the stock has risen substantially in trading on Wednesday.
Market Reaction--The FDA approval of KYNAMRO has sent Isis skyward in trading on Wednesday.
After bottoming out below $8 in November, Isis gradually climbed back into double-digits by late December. It continued to increase into January, as well.
Now, after hovering in the $13-14 range over the past three weeks, Isis is above $15 as of this writing. It currently rests at its highest point since mid-September of 2012.
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