CYBN Clinical trials

Cybin Receives European Approval for EMBRACE, a Multinational Phase 3 Study Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder

Published August 07, 2025 at 11:30 AM

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NYSE American: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 pivo

Related Questions

What is the anticipated timeline for patient enrollment and data read‑out from the EMBRACE trial in Ireland, Poland, and Greece? How will the European approval for the EMBRACE Phase 3 study affect CYBIN’s upcoming cash‑flow forecasts? What is the estimated cost of conducting the multinational Phase 3 trial and its impact on CYBIN’s balance sheet and runway? How does CYBIN’s adjunctive MDD therapy prospectus compare to existing standard‑of‑care treatments and to other pipeline candidates in the neuropsychiatry space? What is the potential upside in market share and revenue if CYB003 receives approval for adjunctive treatment of major depressive disorder? What are the potential regulatory milestones (e.g., EMA or FDA filing) that could be triggered by positive Phase 3 results? How might the market price of CYBN react to interim data releases or a full read‑out from EMBRACE? Are there any known safety or efficacy signals from earlier Phase 2 data on CYB003 that could influence investor sentiment? Will the trial results have implications for CYBIN’s partnership or licensing negotiations with larger pharma partners? How does the size and design of the EMBRACE study compare to CYBIN’s previous clinical programs and to competitor trials in MDD?