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May 6, 2014
07:21 EDTINSYInsys Therapeutics to advance development of CBD to treat epilepsy
Insys Therapeutics announced plans to advance development of its pharmaceutical Cannabidiol, or CBD, a synthetically produced and over 99% pure form of cannabidiol, to treat epilepsy in children and adults. Insys has engaged a large international Clinical Research Organization to provide development and regulatory services and has hired Mark Davis as Senior Clinical Director to oversee this program. Insys plans to file an Investigational New Drug application with the FDA in the second half of 2014 for CBD for the treatment of epilepsy. In pediatrics, Insys plans to pursue development of treatments for Lennox-Gastaut Syndrome and Dravet Syndrome, which are orphan indications.
News For INSY From The Last 14 Days
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December 15, 2014
07:12 EDTINSYInsys Therapeutics price target raised to $57 from $53 at RBC Capital
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December 9, 2014
07:12 EDTINSYInsys Therapeutics receives FDA orphan drug designation for LEP-ETU
Insys Therapeutics announced that the FDA has granted orphan drug designation to its Liposome Entrapped Paclitaxel Easy to Use, or LEP-ETU, candidate for the treatment of gastric cancer. LEP-ETU is an improved formulation of paclitaxel, a widely used chemotherapeutic agent. Insys acquired LEP-ETU during its merger in 2010 with NeoPharm.
December 8, 2014
10:35 EDTINSYInsys Therapeutics management to meet with Piper Jaffray
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10:00 EDTINSYOn The Fly: Analyst Initiation Summary
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08:18 EDTINSYInsys Therapeutics initiated with a Buy at Jefferies
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December 4, 2014
11:03 EDTINSYInsys Therapeutics receives orphan status for gastric cancer treatment
The FDA said it granted Insys Therapeutics orphan status for its treatment of gastric cancer.
07:17 EDTINSYComparison study shows Insys synthetic CBD is identical to plant-based CBD
Independent comparison analyses have found that cannabidiol, or CBD, synthetically produced by Insys Therapeutics is chemically identical to plant-derived CBD. Analyses were conducted independently by Insys and the National Institute on Drug Abuse, or NIDA, part of the National Institutes of Health. The two separately-conducted analyses ascertained that Insys' synthetically produced CBD: Has identical identity and chemical structure to plant-derived CBD; Has identical stereochemistry to plant-derived CBD; both demonstrated the same CBD enantiomer with no enantiomer present, which was confirmed by Chiral Assay; Is more pure, with a 2% higher CBD Assay value than plant-derived CBD; Insys CBD total HPLC purity 99.9% vs. plant-derived CBD at 98.7%; and, Meets all ICH impurity guidelines, with no impurities greater than 0.10%, vs. plant-derived CBD which contained multiple impurities above ICH guidelines.

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