Cybin Inc., a clinical-stage biopharmaceutical company, announced on March 13, 2024, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for CYB003, its novel psychedelic molecule for the treatment of Major Depressive Disorder (MDD). This designation is significant as it is the first known BTD granted by the FDA for an adjunctive psychedelic-based therapy for MDD. The company reported robust and statistically significant improvement in depression symptoms at four months, with 75% of patients achieving remission after two doses of CYB003. The positive data supports the progression to a pivotal Phase 3 multinational study of CYB003 in MDD, expected to commence in mid-2024. The BTD is expected to expedite the review process and increase access to FDA guidance, potentially...Show More

Cybin Inc., a clinical-stage biopharmaceutical company, announced on March 13, 2024, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for CYB003, its novel psychedelic molecule for the treatment of Major Depressive Disorder (MDD). This designation is significant as it is the first known BTD granted by the FDA for an adjunctive psychedelic-based therapy for MDD. The company reported robust and statistically significant improvement in depression symptoms at four months, with 75% of patients achieving remission after two doses of CYB003. The positive data supports the progression to a pivotal Phase 3 multinational study of CYB003 in MDD, expected to commence in mid-2024. The BTD is expected to expedite the review process and increase access to FDA guidance, potentially reducing drug development timelines. Cybin also announced that CYB003 was well tolerated in trials, with no serious drug-related adverse events. The company plans to host a webcast to discuss the CYB003 program updates. Cybin's mission is to revolutionize mental healthcare with innovative psychedelic-based treatments, and the BTD marks a transformational moment in their pursuit of regulatory approval.