Shares of NeuroSearch ($NEUR) took a nosedive after the Danish biotech reported that its application for an experimental Huntington's drug had run into a serious roadblock at the FDA. Regulators are insisting on seeing more data for Huntexil before NeuroSearch can file the NDA--and the news cut more than 20 percent off of the biotech's stock price.
"Based on the preliminary feedback from the (FDA), a U.S. regulatory submission will require additional clinical data to support the effect of Huntexil in the treatment of Huntington's disease," NeuroSearch said in a statement.
NeuroSearch CEO Patrik Dahlen told Reuters that it has several funding options available, including a possible partnership for the lead therapy or the sale of additional shares. "Now that the launch of the product seems to have moved into the future, we need to review that--if a U.S. partnering strategy could be interesting to us in the future," Dahlen told Reuters.
The plan now is to wait for the FDA and European regulators to clarify their positions before NeuroSearch outlines its clinical path forward. Huntexil (pridopidine, previously designated ACR16) is a dopaminergic stabilizer.
- here's the NeuroSearch release
- check out the Reuters story