Tuesday, November 12, 2013 4:06:48 PM
The company has been developing tasimelteon, a potential treatment for a circadian rhythm disorder called Non-24-Hour Disorder that's most commonly found in blind individuals. Those affected don't have the ability to perceive any natural light, resulting in their internal clocks going out of sync with the outside world and causing disrupted nighttime sleep patterns and excessive daytime sleepiness and napping.
The drug has orphan-drug designation in the U.S. and Europe, which is given to novel drugs that treat rare diseases or conditions.
Ahead of an FDA advisory panel meeting on Thursday, an FDA clinical reviewer provided a positive briefing on the drug, stating the treatment had no major safety issues and was effective in treating the disorder.
There are currently no FDA-approved drugs available for the treatment of Non-24-Hour Disorder.
JMP Securities analyst Jason Butler said the briefing allayed many investo r fears on how Thursday's advisory meeting may go, noting it was rare for a medical reviewer to recommend drug approval in a briefing document.
"There's a high likelihood that Thursday is going to be a good day," he said.
After the advisory panel votes on the drug, the FDA will make a final decision on approving the drug in January, he said.
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