Allon, Genta programs win FDA fast-track status
A pair of drug developers won fast track status from the FDA today.
Shares of Canada's Allon Therapeutics jumped 15 percent on the news that davunetide, its therapy for a degenerative brain disease, has been given fast-track status with regulators at the FDA.
"It looks like they have a pathway to get it to market sooner than otherwise now," said David Dean, an analyst at Cormark Securities. "It is certainly positive but there are still a lot of other factors involved." Those other factors include the need to raise more money or find a partner for the program.
Fast track status "provides for early and frequent communication between the FDA and Allon to resolve questions and issues quickly," said CEO Gordon McCauley. "It will ensure that we work with the FDA to gather the critical data needed for approval.
Coincidentally, Xconomy has an interesting, in-depth feature looking at Allon's scientific approach to neurodegenerative disease, which is also being focused on Alzheimer's disease.
Genta, meanwhile, announced that the FDA has granted its fast track designation for tesetaxel, a treatment of patients with advanced gastric cancer. Based on promising results from the Phase IIa, Genta is conducting a confirmatory Phase IIb trial of tesetaxel as a second-line treatment in patients with advanced gastric cancer who have failed a single first-line regimen.