Cybin wins UK MHRA approval to begin EMBRACE, its second pivotal CYB003 depression study

Cybin Inc. (CYBN) — Cybin said the UK's MHRA cleared it to start EMBRACE, the second pivotal study in its multinational Phase 3 PARADIGM program for CYB003, a deuterated psilocin analog carrying FDA Breakthrough Therapy Designation.

EMBRACE is designed to enroll 330 patients with major depressive disorder who respond inadequately to antidepressants, randomizing them to CYB003 16 mg, 8 mg, or placebo across two doses given three weeks apart. The clearance expands the Phase 3 program beyond the US into UK and European sites and keeps Cybin's late-stage timeline on track.

Source: businesswire.com

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