Cybin Inc. provided a year-end summary of its key accomplishments in 2024, emphasizing significant progress in its clinical pipeline. Notable achievements included the announcement of positive 12-month Phase 2 data for CYB003, demonstrating breakthrough efficacy in treating Major Depressive Disorder (MDD).
The company also highlighted the initiation of PARADIGM, its multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD. A crucial regulatory milestone achieved in March 2024 was the receipt of U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for CYB003, which provides an expedited review pathway.
Looking ahead to 2025, Cybin anticipates several key milestones, including the readout of topline efficacy data from its CYB004 Phase 2 study in Generalized Anxiety Disorder (GAD) in the first quarter. The company also plans to initiate the EXTEND and EMBRACE components of its Phase 3 PARADIGM program.
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