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Cybin Reaches Alignment With FDA on Late-Stage Design For Major Depressive Disorder Trial
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Cybin Reaches Alignment With FDA on Late-Stage Design For Major Depressive Disorder Trial
Mar 14, 2024 11:34 AM

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.

Price: 0.43, Change: +0.01, Percent Change: +3.52

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