In a recent interview on NewsNation’s On Balance, FDA Commissioner Dr. Marty Makary affirmed that advancing psychedelic therapies is now a “top priority” for the agency. He emphasized the need to “listen to doctors” and support the growing body of clinical evidence demonstrating how psychedelic-assisted therapy can help treat mental health conditions like depression, anxiety, and PTSD.
“We’ve got to support the science,” said Dr. Makary, referencing the increasing demand from patients and physicians alike.
FDA’s Position on Psychedelics in 2024
The FDA’s evolving stance on psychedelics reflects this momentum. In 2023, the agency issued draft guidance for clinical trials involving psychedelic substances, formally recognizing their potential therapeutic value.
Moreover, several psychedelic compounds, including psilocybin and MDMA, have received Breakthrough Therapy Designation, an FDA classification that expedites the development and review of drugs intended to treat serious conditions.
Key Companies Advancing Psychedelic Therapies
The surge in psychedelic research is being driven by biotech and pharmaceutical companies committed to developing next-generation mental health treatments. Three major players leading this space are Cybin, MindMed, and Compass Pathways.
MindMed (NASDAQ: MNMD)
Mind Medicine Inc. is currently advancing MM120, a proprietary LSD formulation for generalized anxiety disorder (GAD). In recent studies, a single 100-microgram dose of MM120 resulted in a 48% remission rate after 12 weeks.
MindMed is preparing to enter Phase 3 trials, with plans to enroll up to 440 patients.
Cybin Inc. (NYSE American: CYBN)
Toronto-based Cybin is developing CYB003, a deuterated psilocin analog, now in Phase 3 trials for major depressive disorder (MDD).
Cybin also acquired a Phase 1 DMT study from Entheon Biomedical, accelerating the development of CYB004, a deuterated DMT compound aimed at treating anxiety disorders.
Compass Pathways (NASDAQ: CMPS)
Compass Pathways is best known for COMP360, a psilocybin therapy being studied for treatment-resistant depression. The company is also collaborating with Journey Clinical to design training protocols for healthcare providers should COMP360 receive approval.
Why Psychedelic Therapies Matter
Mental health disorders affect over 1 in 5 adults in the U.S., and many patients don’t respond to traditional treatments. Psychedelics, when administered under medical supervision, have shown rapid and lasting improvements with minimal dosing and lower dependency risks compared to SSRIs or benzodiazepines.
As the FDA signals greater regulatory openness, these companies are uniquely positioned to bring innovative, evidence-based treatments to market.
Final Thoughts
The renewed focus from the FDA on psychedelic therapy research marks a turning point in mental healthcare innovation. With companies like Cybin, MindMed, and Compass Pathways at the helm, the future of mental health treatment could look radically different in the years ahead.
Watch the Full Interview:
FDA Commissioner: Psychedelic Research “Top Priority”
