share_log

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

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

Cybin | 6-K：外国发行人报告
SEC announcement ·  03/14 16:05
Moomoo AI 已提取核心信息
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.
临床阶段的生物制药公司Cybin Inc. 宣布，与美国食品药品管理局成功举行了针对用于治疗重度抑郁症（MDD）的氘化迷幻药类似物 CYB003 的第二阶段会议。该公司计划在2024年中期左右启动第三阶段计划，包括15个美国临床试验地点和其他欧洲地点。CYB003 显示抑郁症状明显持续改善，75% 的患者在接种两剂后得到缓解。美国食品药品管理局已授予 CYB003 突破性疗法称号，加快了审查过程并增加了美国食品药品管理局的参与。第三阶段计划将包括两项对照研究和一项长期延期，主要终点是第6周MADRS总分的变化。Cybin已与全球临床试验公司合作管理该项目。该公司首席执行官道格·德赖斯代尔对 CYB003 的临床状况及其对现有耐多药疗法进行重大改进的潜力表示了信心。
临床阶段的生物制药公司Cybin Inc. 宣布，与美国食品药品管理局成功举行了针对用于治疗重度抑郁症（MDD）的氘化迷幻药类似物 CYB003 的第二阶段会议。该公司计划在2024年中期左右启动第三阶段计划，包括15个美国临床试验地点和其他欧洲地点。CYB003 显示抑郁症状明显持续改善，75% 的患者在接种两剂后得到缓解。美国食品药品管理局已授予 CYB003 突破性疗法称号，加快了审查过程并增加了美国食品药品管理局的参与。第三阶段计划将包括两项对照研究和一项长期延期，主要终点是第6周MADRS总分的变化。Cybin已与全球临床试验公司合作管理该项目。该公司首席执行官道格·德赖斯代尔对 CYB003 的临床状况及其对现有耐多药疗法进行重大改进的潜力表示了信心。
有用
没用

该公告为独立文件：

独立文件1  查看翻译

独立文件2  查看翻译

声明：本内容仅用作提供资讯及教育之目的，不构成对任何特定投资或投资策略的推荐或认可。 更多信息