Gentleman (and ladies), restart your engines.
As expected, Dyax Corp. and FDA have resolved questions the agency had regarding problems with rat deaths in repeat-dosing toxicity studies, and the clinical hold on Phase II trials with DX-88 for hereditary angioedema has been lifted.
So has the company's stock price (NASDAQ:DYAX), which jumped $2.06 Friday, or 18.9 percent, to close at $12.96.
Late last month, Dyax lost 28 percent to close at $10.26 on the day news broke of the FDA's clinical hold, which the company said it hoped to resolve quickly. (See BioWorld Today, May 26, 2004.)
As the clinical studies continue, Dyax and joint-venture partner Genzyme Corp., of Cambridge, Mass., will be working with the FDA to design more preclinical studies in support of eventual approval of the anti-inflammatory small protein.
On its own, Dyax is developing DX-88 for the treatment of patients undergoing on-pump coronary artery bypass grafting (CABG) surgery. No trials in that indication are under way, but positive Phase I/II data from a 42-patient trial in CABG were announced by Dyax in December 2003, and Dyax said plans remain in place to start two more Phase II studies in that indication in the second half of this year.
Genzyme's stock (NASDAQ:GENZ) closed Friday at $43, up 8 cents.