Health Care

The Evolving Psychedelic Therapy Landscape with Compass Pathways

Mar. 24, 2026

Guest: Kabir Nath, CEO, Compass Pathways

Host: Ritu Baral, Managing Director, Health Care – Biotechnology Research Analyst, TD Cowen

Our discussion with Compass CEO Kabir Nath focuses on the FDA’s current approach to psychedelic drug development, what it signals for the broader psychiatry landscape and the evolving interventional psychiatry infrastructure in the community setting. Nath highlights a highly engaged and collaborative FDA Psychiatry Division, noting the agency's recent acceptance of 7-8 psychedelic therapy Investigational New Drug application (IND) and its willingness to work constructively with sponsors despite relatively small datasets in early development. He highlights recent positive psychedelic clinical datasets as many traditional antidepressant approaches continue to fall short, including Compass’s successful Phase 2 and 3 treatment-resistant depression (TRD) results across three standardized studies as evidence of the category’s clinical potential.

The conversation also explores how the existing interventional psychiatry infrastructure in the community setting, shaped in part by the successful launch of Spravato, has transformed the field and lowered barriers for future commercial uptake of innovative psychedelic therapies. We learn about 7,200+ certified Spravato treatment sites now in place and increasing familiarity with Risk Evaluation and Mitigation Strategy (REMS)-based models. Nath emphasizes the importance of bringing forward additional options in the psychedelic space to address significant unmet need across major depressive disorder (MDD), TRD and posttraumatic stress disorder (PTSD) as psychiatry treatment paradigms continue to evolve.

This podcast was originally recorded on March 3, 2026.

Full transcript

Speaker 1:
Welcome to TD Cowen Insights, a space that brings leading thinkers together to share insights and ideas shaping the world around us. Join us as we converse with the top minds who are influencing our global sectors.
Ritu Baral:
I'm Ritu Baral, one of the senior biotech analysts at TD Cowen, and I'm here live at the 46 annual TD Cowen Healthcare Conference. I'm here with CEO of Compass Pathways, Kabir Nath.
Kabir, welcome. Thanks for joining us.
Kabir Nath:
Thanks very much, Ritu. It's great to be here.
Ritu Baral:
I wanted to ask you about your lead compound, Comp360, which is barreling towards approval and commercial launch, and more holistic questions about the landscape it will be entering into. One, you're going to be in front of the FDA. Soon, how have the FDA and their senior regulators approach psychedelic drug development? How would you describe engagement and collaboration levels?
Kabir Nath:
I think what you're seeing now is an extremely engaged psychiatry division within the FDA around psychedelics, and there are a few signs of that.
First, there are now, I think, seven or eight compounds that have been awarded breakthrough designation, which again suggests that even with initial small data sets, they're seeing real promise.
Second, the division themselves has acknowledged publicly that a pretty significant part of their workload now is psychedelics, somewhere between a third and a half of all the INDs that they're looking at are in fact for psychedelics.
And then I think thirdly, just look at the broader psychiatry landscape right now. As we all know, psychiatry trials are bedeviled by the issue of replicability. We've seen a number of, shall we say, more traditional approaches over the last year, year and a half from big companies absolutely fail yet again at that hurdle. At the same time, you've now seen several psychedelic companies produce really good data. For Compass ourselves, we seem to have actually managed that bogie extremely effectively by now being three for three with actually very consistent results.
Ritu Baral:
And standardized. Standardized results.
Kabir Nath:
Absolutely. And treatment resistant depression, which is one of the most notoriously hard indications to study.
I think for all those reasons from the FDA's perspective, this is their mandate is to bring innovative medicines to patients in serious need as quickly as possible. I think it's pretty clear now that within psychiatry, psychedelics are going to potentially play an important part in that. I would say very engaged, very collaborative, and really jointly problem solving.
I mean, there are clearly challenges in the design and interpretation of studies with psychedelics, but I would say over the last few years, we've have a really collaborative, engaged relationship.
Ritu Baral:
How well has Spravato prepared the psychiatric community for the commercial availability of psychedelics from a paradigm perspective, from a logistics perspective, and also from a reimbursement perspective?
Kabir Nath:
Clearly the success, and I think now we can call it a success of Spravato, maybe in the early days, that wasn't so clear, the success of Spravato is clearly a really important leading indicator for the sector.
I would say from a treatment paradigm, while obviously it is a thought of as a psychedelic with its potential dissociated properties, in one sense, it's really not that much of an advance from daily orals. It's still chronic. It's still something you have to take essentially forever, albeit on a different frequency. But clearly in terms of the infrastructure to deliver this in clinic settings, it's been profoundly transformative.
When Spravato launched, you could number the places that could potentially deliver a substance like esketamine or the psychedelic [inaudible 00:03:58] in the hundreds. Now, as we all know, there are 7,000 or more, it's continuing to grow very fast. That kind of growth in interventional psychiatry infrastructure, dealing with REMS, dealing with the fact that there are potentially side effects that need to be monitored for a period of time, I think all of that has been really helpful.
From a payer perspective, I think it's more specific to TRD, frankly, because obviously in TRD, there was only one much older drug approved. By and large, people have just been trying to use drugs that are only approved for MDD with limited success. Actually, I think from a reimbursement perspective as something new in TRD, it's obviously helpful to us, Compass and others in TRD. I'm not sure you can yet generalize that to what it means for psychedelics as well.
Ritu Baral:
And then how do you see the psychiatric space evolving with potential multiple approved psychedelic therapies and emerging next generation therapies as well?
Kabir Nath:
I think it's important that what each of us are doing is bringing forward another option in the specific areas in which we're working.
From our perspective at Compass, I'm actually really pleased to see other psychedelic companies generating really good data. Let's remember that the need here is huge. Treatment resistant depression, four million people. PTSD, 13 million people. MDD, as we know, people who do not get good outcomes, maybe 50 to 60% of that patient population. There is clearly going to be room for a number of different approaches.
I think the other thing to say is all of us clearly are doing very robust, rigorous clinical studies with certain protocols, but we fully expect over time medical and clinical practice to inform how's these medicines are really used in practice. You can imagine sequential use and all sorts of things happening. I don't think combination in the strict sense of two at the same time, but you can clearly see sequential use different paradigms emerging. I think that's the way psychiatry has always evolved.
Ritu Baral:
Thank you, Kabir. Thanks for all the insights.
Kabir Nath:
Thanks very much.
Speaker 1:
Thanks for joining us. Stay tuned for the next episode of TD Cowen Insights.

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Ritu Baral

Managing Director, Health Care – Biotechnology Research Analyst, TD Cowen

Ritu Baral
Managing Director, Health Care – Biotechnology Research Analyst, TD Cowen

Biography

Ritu Baral joined TD Cowen in August 2014 as a senior biotechnology analyst and managing director. Ms. Baral has more than nineteen years of experience in biotechnology finance, including over sixteen years in biotechnology equity research. Her coverage has focused on rare diseases and neurology. From August 2006 until June 2014, she held a series of positions in biotechnology equity research at Canaccord Genuity, including senior analyst and managing director. Before that, Ms. Baral was an equity research associate at JMP Securities and a senior associate at the Trout Group. Previously, she was a research associate at Columbia University’s Department of Medicine, where she participated in neuroendocrine research focused on appetite and metabolism regulation, and completed graduate coursework in immunology.

Ms. Baral graduated with a BA in biological sciences from Barnard College. She is involved in a number of rare disease patient advocacy organizations, including as a board member of the Everylife Foundation for Rare Disease and the Industry Advisory Board of the National Tay-Sachs and Allied Diseases Foundation. She was previously on the board of directors of the Pulmonary Fibrosis Foundation.