Acusphere is a specialty pharmaceutical company, primarily focused on the development of Imagify™ (Perflubutane Polymer Microspheres) for Injectible Suspension, a cardiovascular drug for the detection of coronary artery disease (CAD). The Company has submitted the Marketing Authorisation Application (MAA) for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) lyophilisate for dispersion for injection with the European Medicines Agency (EMA) to support the regulatory review of Imagify in the European Union (EU). The MAA was submitted via the centralized procedure that enables simultaneous approval in all EU countries. The validation process for the MAA has been successfully completed, and the substantive review process is now underway by the Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion is expected in Q4 2013. Acusphere has reached agreement with the Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on the design of a placebo trial to demonstrate that stress ultrasound with Imagify has superior efficacy to stress ultrasound without Imagify.
October 24, 2012
Acusphere, Inc. announces submission of Marketing Authorisation Application for Imagify™ in Europe and start of procedural review
July 09, 2012
Acusphere, Inc. announces completion of Marketing Authorisation Application for Imagify™ in Europe; secures additional financing
December 19, 2011
Acusphere, Inc. Issues Letter to Shareholders