Psychedelic biotechnology companies are continuing to find clinical validation.
What’s happening:
- Psychedelic biotechnology company Cybin (NYSE: CYBN) has been granted a Breakthrough Therapy designation from the FDA for their novel psychedelic molecule CYB003 for Major Depressive Disorder
- Cybin has also announced they have raised $150M USD to fund the rest of their clinical trial development in a new financing led by Deep Track Capital
Why it matters:
- This is the first ever Breakthrough Therapy designation for a psychedelic based therapy as a therapeutic treatment for Major Depressive Disorder
- Breakthrough Therapy designations from the FDA provide an expedited review pathway for future clinical trials, which can meaningfully reduce the time it takes to bring a new drug closer to approval
By the numbers:
- 75% of patients in Cybin’s clinical trial saw a meaningful reduction in depressive symptoms after receiving just two doses of CBY003
Going deeper:
- Cybin’s novel molecule CYB003 is a deuterated psilocybin analogue which if approved would become the world’s first adjunctive psychedelic treatment for Major Depressive Disorder
- Cybin has become just the third publicly traded psychedelic drug developer to be granted a Breakthrough Therapy designation from the FDA, joining COMPASS Pathways (NASDAQ: CMPS) and MindMed (NASDAQ: MNMD)
- Legendary Wall Street hedge fund manager Steve Cohen is a notable backer of Cybin and has been continuing to add to his ownership stake through his fund Point72
