Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder
Cybin Inc. Common Shares (CYBN)
Company Research
Source: Business Wire
- Breakthrough Therapy Designation (“BTD”) provides an expedited review pathway, as well as increased access to U.S. Food and Drug Administration (“FDA”) guidance on trial design, with the potential to significantly reduce drug development timelines -- First known BTD granted by the FDA for an adjunctive psychedelic based therapy for the treatment of Major Depressive Disorder (“MDD”) -- Robust, sustained and statistically significant improvement in depression symptoms at four months with 75% of patients in remission from depression after two doses (16mg) -- Impressive mean 22-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score from baseline at four months -- Data supports progression to a pivotal Phase 3 multinational study of CYB003 in MDD in mid-2024 -- Achievement of milestones expedites and de-risks CYB003 development program -- Company to host webcast to discuss CYB003 program updates today at 8:30 a.m. ET -This news release constitutes a “designated news
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CYBN
News
- Cybin to Participate at the 27th Annual Milken Institute Global ConferenceBusiness Wire
- Cybin Announces Publication of Research Manuscript in the Journal of Medicinal Chemistry [Yahoo! Finance]Yahoo! Finance
- Cybin Announces Publication of Research Manuscript in the Journal of Medicinal ChemistryBusiness Wire
- Cedar Clinical Research selected as clinical research site for Cybin's Phase 3 Study of CYB003 [Yahoo! Finance]Yahoo! Finance
- Cybin Announces Grant of Additional U.S. Patent in Support of its CYB003 Breakthrough Therapy Program for Major Depressive Disorder [Yahoo! Finance]Yahoo! Finance
CYBN
Sec Filings
- 4/25/24 - Form 6-K
- 4/22/24 - Form D
- 4/18/24 - Form 6-K
- CYBN's page on the SEC website