02:18 PM EDT, 03/14/2024 (MT Newswires) -- Cybin ( CYBN ) said Thursday it has received minutes from a End-of-Phase-2 meeting with the US Food and Drug Administration and reached alignment on its Phase 3 program design for CYB003 for the adjunctive treatment of major depressive disorder.
Cybin ( CYBN ) said it aims to start enrollment in mid-2024, with multiple sites targeted for the program, which will comprise of two studies and a long-term extension.
On Wednesday, the FDA granted its breakthrough therapy designation to CYB003 for the adjunctive treatment of MDD.
Shares of Cybin ( CYBN ) rose more than 3% in recent trading activity.
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