News & Events
ASX Announcement First Minimally Invasive C-Pulse Procedure Performed at University of Louisville Sydney, Australia
15 / 06 / 2010
CoDa Therapeutics Achieves Positive Phase 2 Efficacy of NEXAGON® in Chronic Venous Leg Ulcers
25 / 05 / 2010
CoDa Therapeutics Achieves Positive Phase 2 Efficacy of NEXAGON® in Chronic Venous Leg Ulcers - 69% Reduction in Venous Leg Ulcer Size in High-Dose Arm at 4 Weeks - 31% of Wounds Completely Healed in High-Dose Arm at 4 Weeks
CHEMGENEX TO HOST INVESTOR BRIEFING MELBOURNE, Australia, and MENLO PARK, California U.S.A. (4 May 2010)
04 / 05 / 2010
CHEMGENEX RECEIVES A COMPLETE RESPONSE LETTER FROM THE FDA FOR OMAPROTM MELBOURNE, Australia, and MENLO PARK, California U.S.A. (12th April 2010)
12 / 04 / 2010
ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administrationâ??s (FDA) Office of Oncology Drug Products has issued a complete response letter regarding the new drug application (NDA) for OMAPROâ?˘ (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation. The complete response letter does not contain a request for a new study, nor is there a request for enrollment of additional patients into the pivotal study on OMAPRO.
US Food and Drug Administration's Oncologic Drug Advisory Committee Recommends Chemgenex Validate a Diagnostic Prior to Approval of OMAPROâ?˘ in Chronic Myeloid Leukemia Patients with T315I Mutation
23 / 03 / 2010
ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today that the U.S. Food and Drug Administrationâ??s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7-1 that a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of OMAPROâ?˘ (omacetaxine mepesuccinate).