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Psychedelic Depression Drug Lands Breakthrough Therapy Designation From The FDA

March 14, 2024
x min read

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

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