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CYB003 received FDA Breakthrough Therapy Designation in March 2024. In a Phase 2 study for MDD, it showed a remarkable efficacy at 12 months—100% response rate and a 71% remission rate among participants who received two doses. The pivotal multinational Phase 3 PARADIGM™ program is ongoing. A Phase 2 proof-of-concept study of CYB004 in GAD is underway with topline data expected Q1 2025. The pipeline also includes non-hallucinogenic neuroplastogens under investigation.
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