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0.00351591413767582 0.00129533678756483 0.00666173205033318 -0.0149888971132494 -0.0749444855662471 -0.074759437453738 -0.0192450037009622 -0.0284974093264248
Stock impact report

Cybin spikes after FDA breakthrough tag for psychedelic therapy [Seeking Alpha]

Cybin Inc. Common Shares (CYBN) 
Company Research Source: Seeking Alpha
Food and Drug Administration (FDA) granted the breakthrough therapy designation for its psychedelic-based experimental treatment, CYB003. The designation covers CYBN's investigations into CYB003 as an adjunctive treatment for major depressive disorder (MDD). The FDA's breakthrough therapy designation aims to speed up the development and review of treatments targeted at serious or life-threatening conditions. Developers can receive intensive regulatory support for studies into breakthrough drugs with potential eligibility for the FDA's priority review. Additionally, Cybin ( CYBN ) announced four-week data from its Phase 2 trial for CYB003 in MDD, highlighting that 75% of patients were in remission from depression after two doses of 16mg therapy over the period. Meanwhile, 60% and 75% of patients were in remission in response to 12 mg and 16 mg doses, respectively. The drug was well tolerated, with no treatment-related serious adverse events. The company intends to advance CYB00 Show less Read more
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