The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis
Efdoralprin Alfa was well tolerated, with a safety profile comparable to plasma-derived therapy
OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy
The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A
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