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- EMBRACE, the second study within the Phase 3 PARADIGM program, will enroll 330 participants at approximately 60 clinical sites across the United States, Europe, the United Kingdom, and Australia -
- European CTA approval to initiate the EMBRACE study in Ireland, Poland, and Greece has been received -
- Recently received Medicines and Healthcare products Regulatory Agency ("MHRA") approval to commence EMBRACE in the United Kingdom -
- Data from completed Phase 2 MDD study showed that 71% of participants were in remission and 100% of participants responded to treatment at 12 months after just two 16 mg doses of CYB003 -
Cybin Inc. (NYSE:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that its Clinical Trial Application ("CTA") has been approved by the Irish Medicines Board, acting as the reference Member state, to initiate the EMBRACE™ study in Ireland, Poland, and Greece. EMBRACE is the second pivotal study in PARADIGM®, the Company's Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The Company also recently announced approval from the Medical and Healthcare products Regulatory Agency ("MHRA") to commence EMBRACE in the United Kingdom.
CYB003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the adjunctive treatment of Major Depressive Disorder ("MDD").
Posted In: CYBN
