Acusphere awaits FDA statement on experimental cardiovascular drug
Acusphere, a pharmaceutical firm, has announced that there has been no U.S. FDA statement on its experimental cardiovascular drug, Imagify. The Watertown, Mass.-based believes that Imagify with ultrasound will provide an alternative to nuclear stress testing in diagnosing artery disease.
In May, Acusphere said its second Phase 3 clinical trial of Imagify injectable suspension did not achieve the specificity endpoint that the company had previously reported in its fist Phase 3 trial.
The firm plans to file its new drug application with the FDA in early next year, instead at this year’s end, as it previously intended.
In May, Acusphere said its second Phase 3 clinical trial of Imagify injectable suspension did not achieve the specificity endpoint that the company had previously reported in its fist Phase 3 trial.
The firm plans to file its new drug application with the FDA in early next year, instead at this year’s end, as it previously intended.