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).
Xenome Licenses Peptides from xdiscoverTM Library to MedImmune Brisbane, Australia - 23 March 2010
23 / 03 / 2010
ChemGenex, Hospira, Announce Agreement to License, Develop and Commercialize Leukemia Drug in Europe
18 / 12 / 2009
ChemGenexâ??s Omaproâ?¢ Featured During ASH Oral Session
09 / 12 / 2009
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omaproâ?¢ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who are resistant or intolerant to two or more tyrosine kinase inhibitors (TKI). New data were presented at the 51st Annual American Society of Hematology Meeting in New Orleans, Louisiana.
Pivotal Data on ChemGenexâ??s Omaproâ?¢ Highlighted at ASH Press Conference
07 / 12 / 2009
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omaproâ?¢ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. New data was presented at a pre-conference press showcase at the 51st Annual American Society of Hematology Annual Meeting in New Orleans, Louisiana.
ChemGenex to Present Positive Data for Omaproâ?¢ from Multiple Clinical Trials at ASH
01 / 12 / 2009
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that updated clinical data from several of its clinical trials with Omaproâ?¢ (omacetaxine mepesuccinate) will be presented at the upcoming 51st American Society of Hematology Annual Meeting in New Orleans, Louisiana.
Chairmanâ??s Address for ChemGenex Pharmaceuticals Limited Annual General Meeting
30 / 11 / 2009
The last twelve months have been truly transformational for ChemGenex and we sit now with the possibility of drug approvals in the worldâ??s two largest pharmaceutical markets, the USA and Europe, and the potential launch of Omapro by our own commercial team in the USA next year.
ChemGenexâ??s Marketing Authorization Application for Omacetaxine Mepesuccinate Validated by the European Medicines Agency
27 / 11 / 2009
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the European Medicines Agency ("EMEA") has determined that the Marketing Authorization Application ("MAA") for omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation is valid...
LEO Pharma Completes Peplin Acquisition; Peplin to Continue as an Independent Subsidiary
12 / 11 / 2009
Peplin, Inc. (ASX:PLI) today announced that it has completed its merger with LEO Pharma A/S (LEO) after obtaining the approval of the majority of Peplin stockholders. The deal was originally announced on 3 September, 2009 when LEO, a privately-held, leading global pharmaceutical company within Dermatology and Critical Care, agreed to acquire all outstanding securities of Peplin for approximately US$287.5 million in cash. The merger consideration will be distributed to holders of common stock and CDIs promptly.
Verva Announces Appointment of Professor Michael Cowley to its Board of Directors
11 / 11 / 2009
Verva Pharmaceuticals Ltd. today announced that Professor. Michael A. Cowley, Director of the Monash Obesity & Diabetes Institute, has joined the Company's Board as a non-executive Director. Professor Cowley is a Victorian Endowment for Science, Knowledge and Innovation (VESKI) Innovation Fellow and a Pfizer Senior Research Fellow for 2009. Recently Professor Cowley was awarded the prestigious Commonwealth Science Minister's Prize for Life Scientist of the Year.
ChemGenex Announces FDA Accepts NDA for Omaproâ?¢ (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status
10 / 11 / 2009
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food & Drug Administration (FDA) has accepted the companyâ??s New Drug Application (NDA) for Omaproâ?¢ (omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. The NDA has also been granted Priority Review. A Priority Review designation is given to drugs that offer ...