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Cybin | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SEC announcement ·  Mar 14 16:05
Summary by Moomoo AI
Cybin Inc., a clinical-stage biopharmaceutical company, announced a successful End-of-Phase 2 meeting with the FDA for CYB003, a deuterated psilocybin analog for treating Major Depressive Disorder (MDD). The company plans to initiate a Phase 3 program around mid-2024, with 15 U.S. clinical trial sites and additional European sites. CYB003 has shown robust and sustained improvement in depression symptoms, with 75% of patients achieving remission after two doses. The FDA has granted CYB003 Breakthrough Therapy Designation, expediting the review process and providing increased FDA engagement. The Phase 3 program will include two controlled studies and a long-term extension, with the primary endpoint being the change in MADRS total score at Week 6. Cybin has partnered with Worldwide Clinical Trials for the management of the program. The company's CEO, Doug Drysdale, expressed confidence in the clinical profile of CYB003 and its potential to offer significant improvements over existing therapies for MDD.
Cybin Inc., a clinical-stage biopharmaceutical company, announced a successful End-of-Phase 2 meeting with the FDA for CYB003, a deuterated psilocybin analog for treating Major Depressive Disorder (MDD). The company plans to initiate a Phase 3 program around mid-2024, with 15 U.S. clinical trial sites and additional European sites. CYB003 has shown robust and sustained improvement in depression symptoms, with 75% of patients achieving remission after two doses. The FDA has granted CYB003 Breakthrough Therapy Designation, expediting the review process and providing increased FDA engagement. The Phase 3 program will include two controlled studies and a long-term extension, with the primary endpoint being the change in MADRS total score at Week 6. Cybin has partnered with Worldwide Clinical Trials for the management of the program. The company's CEO, Doug Drysdale, expressed confidence in the clinical profile of CYB003 and its potential to offer significant improvements over existing therapies for MDD.
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