Pozen stock took a painful dive this morning after GlaxoSmithKline announced that their two-in-one migraine drug Trexima would be delayed yet again--this time to satisfy FDA demands for more information on evidence of genotoxicity seen in a preclinical study. That genotoxicity was seen in Trexima, but was not apparent when the two compounds used in Trexima were studied alone. That was bitter news for investors, who were hoping that the second approvable letter from the FDA--the first arrived more than a year ago--would be the charm. They drove down Pozen's value by close to half. Researchers say they'll shoot for an early meeting with the FDA to better determine how to proceed.
- check out the release
- here's the AP report on Pozen