IntelGenx Shares meet Volatility with FDA Approval

IntelGenx Technologies Corp. (OTC:IGXT) surged this morning on FDA approval to a high of $.72 only to crash all the way down to a low of $.47 this morning. IGXT last traded at $.56 for a loss so far on the day of 5.9%… Get my next ALERT 100% FREE

IGXT today announced that the U.S. Food and Drug Administration (FDA) has approved IntelGenx’ lead product, CPI-300, for patients with Major Depressive Disorder. CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.

“This is a defining moment for IntelGenx, as we have now clearly demonstrated our ability to independently take a product through development to regulatory approval,” said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. “We believe physicians will embrace CPI-300 as a more convenient and safe alternative for their patients requiring high-dose anti-depressant therapy. So we now turn our focus towards the commercialization of CPI-300, with the objective of a product launch with a partner by the second quarter of 2012.”

IntelGenx has been in active licensing discussions with several leading generic and specialty pharmaceutical companies and anticipates finalizing a commercialization agreement soon. As previously announced, the company has entered into an agreement with Pillar5 Pharma Inc. for the commercial manufacturing of the product. (Read more)