NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Breakthrough Therapy designation for pain associated with DPN granted by FDA
Submission based on results from pivotal phase III trial showing all primary endpoints met
Longest survival follow-up ever reported for immunotherapy treatment in this setting
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide
Global Phase-3 study initiation expected in the second half of 2024
The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development
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