New Hope for People Battling With Depression

Summary

Bloomberg Businessweek Podcast Summary

Episode: New Hope for People Battling With Depression
Date: December 8, 2025
Hosts: Carol Massar & Tim Stanovec
Guest: Kabir Nath, CEO of Compass Pathways

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Episode Overview

This episode delves into the resurgence and promise of psychedelic therapies—specifically psilocybin—for treatment-resistant depression. The hosts speak with Kabir Nath, CEO of Compass Pathways, whose leading candidate, COMP360, is showing transformative potential in clinical trials. The conversation covers market opportunities, regulatory status, clinical progress, study design choices, accessibility, safety, and the future of psychedelic-assisted therapies.

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Key Discussion Points & Insights

1. State of the Psychedelics Market

• Resurgence After Downturn: The psychedelic drug sector is rebounding after setbacks in 2022, with Bloomberg Intelligence projecting a $7 billion market by 2032.
  • [02:02] Tim Stanovec: "Bloomberg Intelligence analysts ... estimate that the psychedelic drug market could grow to $7 billion by 2032."
• Market Volatility & Promise: Despite historic volatility, the industry is regarded as a high-growth space, with Compass Pathways holding a central role.

2. Clinical Progress at Compass Pathways

• Major Milestones:
  • Compass Pathways has completed enrollment for its second pivotal (Phase III) clinical trial for treatment-resistant depression (TRD) ahead of schedule.
  • The company anticipates releasing primary data in Q1 2026, opening the path to an FDA submission and possible accelerated approval.
    • [03:00] Kabir Nath: "We've completed... the enrollment in our second final stage study, which we did ahead of expectations... We expect to have the primary data from that in first quarter of next year."

3. Designing Robust Clinical Trials

• Lessons Learned: Kabir stresses their study design has proactively avoided pitfalls seen in prior psychedelic applications (e.g., MDMA for PTSD) by maintaining rigorous data collection, especially regarding side effects, abuse potential, and bias.
  • [04:41] Kabir Nath: "We are collecting full side effect data... to make sure that there is really no abuse potential for this. And we've been collecting that right from the beginning."
• Abuse Potential: No evidence of psilocybin abuse history.
  • [05:19] Kabir Nath: "There is no history in psilocybin of people actually seeking it out or of any abuse potential with psilocybin, which is an important point."

4. Intellectual Property & Competitive Edge

• Patenting a Natural Compound:
  • COMP360 is a synthetic form of psilocybin, with patent protection through 2038.
    • [05:48] Kabir Nath: "Our medicine comp360 is a fully synthetic formulation of psilocybin. We have... robust protection till 2038..."

5. Regulatory Relationships and Timelines

• Agency Communication: Compass maintains a long-term working relationship with the FDA's psychiatry division, which Kabir credits for the program's progress.
  • [06:14] Kabir Nath: "We are focused on an excellent relationship with the psychiatry division of the fda."
• Launch Outlook: Commercial launch could come as early as late 2026.
  • [07:28] Kabir Nath: "We are preparing to be ready for a commercial launch from the end of 2026."

6. Treatment Modality and Impact

• Session-Based Model: Unlike daily antidepressants, COMP360 is administered in single monitored sessions that may deliver relief lasting at least six weeks, with the potential for additional sessions as needed.
  • [08:08] Kabir Nath: "A single session can produce a dramatic response that lasts for six weeks... What we are showing is truly transformative..."
• Safety Protocols: Each session is monitored by medical professionals in safe clinical environments, not for at-home self-administration.
  • [12:39] Kabir Nath: "This is very much delivered in a safe environment in a medical environment with somebody in the room who is medically trained..."

7. Expansion to Other Disorders

• Pipeline Growth: Compass is designing trials for PTSD—the only FDA-approved drugs for this indication are decades old. Women constitute 60% of PTSD sufferers, despite public focus on veterans.
  • [09:02] Kabir Nath: "We have designed a study and that we will be kicking that off next year."

8. Market Share, Price, & Insurance

• Market Potential: With a 2-3 year lead on competitors, Compass aims to serve 3 million Americans with TRD. Existing treatments only reach about 70-100k.
  • [10:54] Kabir Nath: "We have the potential to be ahead... by two to three years. For us, this is about... the 3 million patients that need a new treatment option."
• Access & Insurance: The company is committed to broad access via insurer partnerships. Cost-effectiveness arguments stress reduced hospitalizations and emergency care.
  • [09:52] Kabir Nath: "Compass was set up in order to ensure broad and equitable access... and that means the ability to work with insurers..."
• Pricing TBD: Exact price per session is not set, pending long-term data on dosing frequency and durability of effect.

9. Safety and Side Effects

• Minimal Concerns: Temporary headache and nausea are the main side effects reported, usually resolving within a day. Ongoing external and independent safety monitoring has raised no red flags.
  • [12:00] Kabir Nath: "On the day of dosing, there's some headache, some nausea, and that passes by the second day at most... [Our monitoring board] have seen no unexpected or concerning side effects..."

10. Regulatory Climate

• Optimistic Outlook: Kabir is hopeful for a supportive FDA relationship based on years of constructive engagement.
  • [13:07] Kabir Nath: "With the psychiatry division, we have an excellent relationship... over six, seven years and we expect that."

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Notable Quotes & Memorable Moments

• [02:19] Co-host: "That's a decent market." (on the $7 billion projection, capturing the co-hosts' optimism and market awareness)
• [03:00] Kabir Nath: “We’re now in a position to potentially accelerate getting this medicine to patients who so urgently need it."
• [05:19] Kabir Nath: “There is no history in psilocybin of people actually seeking it out or of any abuse potential...”
• [08:08] Kabir Nath: "A single session can produce a dramatic response that lasts for six weeks."
• [09:52] Kabir Nath: “Compass was set up in order to ensure broad and equitable access for patients.”
• [12:39] Kabir Nath: "This is very much delivered in a safe environment... with somebody who is medically trained, who's there just to assure patient safety and comfort."
• [12:52] Kabir Nath: “I absolutely do and we’re excited about that potential.” (on whether he sees the finish line for FDA approval/commercialization)

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Key Segment Timestamps

• [01:59] – Psychedelic market reemergence & background context
• [02:42] – Compass Pathway’s clinical and regulatory updates
• [04:20] – Study design and addressing history of abuse/side effects
• [05:26] – Intellectual property strategy for the medicine
• [06:42] – Regulatory timeline towards market release
• [07:28] – Projected commercial launch Q4 2026
• [08:08] – Efficacy and unique treatment regimen (single session impact)
• [09:02] – Expansion beyond depression (PTSD focus)
• [09:52] – Access, insurance, and patient value
• [10:54] – Market leadership and patient reach
• [12:00] – Safety profile and side effect discussion
• [12:39] – In-clinic administration and patient safeguards
• [13:07] – Regulatory climate and optimism

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Conclusion

The episode provides an in-depth look at Compass Pathways’ breakthrough work with psilocybin therapy for depression, highlighting both scientific promise and business strategy. The discussion underscores the transformative clinical potential, the cautious optimism around regulatory progress, and an ongoing commitment to accessibility and safety. Kabir Nath’s insights paint a hopeful picture for millions with treatment-resistant depression and set the stage for further innovation in mental health therapeutics.

Transcript

[Carol Massar]

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[Carol Massar]

You're listening to Bloomberg Business Week with Carol Massar and Tim Stanovec on Bloomberg Radio.

[Tim Stanovec]

Remember when psychedelics were like all the rage?

[Co-host (possibly Carol Massar or another Bloomberg host)]

Totally.

[Tim Stanovec]

And then they've been talking about them for a while and then they weren't. Because in 2022 we saw prices collapse, money was pulling out, trial results weren't where they needed to be. It's having a resurgence. According to Bloomberg Intelligence analysts, they're estimating that the psychedelic drug market could grow to $7 billion by 2032.

[Co-host (possibly Carol Massar or another Bloomberg host)]

That's a decent market.

[Tim Stanovec]

Yeah.

[Kabir Nath]

Yeah.

[Tim Stanovec]

So the market potential here, they say, is clear. But companies could still run into issues with regulators, this we know, and in upscaling the products. So back with us here in Studio, which we're so happy about, is Kabir Nath, chief executive officer of Compass Pathways. And so great to have you back. You were here last in July, Kabir.

[Kabir Nath]

That's right. And it's great to be back. Thanks for the invitation.

[Tim Stanovec]

So tell us. First off, just a little background for folks. This is your company, Compass Pathways, $515 million market cap not too shabby. Stock is up 4, 42% year to date. We know there's a lot of volatility in this industry too, but that's not too shabby either. Tell us what's changed since you were in our studios in July.

[Kabir Nath]

Thank you. So we're excited about the fact that we're now in a position to potentially accelerate getting this medicine to patients who so urgently need it. Let me remind you that there are 3 million patients living with persistent depression in the U.S. fewer than 5% of them today are treated with a medicine that was actually specifically studied for or is approved for treatment resistant depression. And this is depression that is chronic. It's refractory. Often people are unable to work. It has dramatic direct healthcare costs in terms of costs of emergency room admissions in psychiatric care, but it also has real social costs for these people. So what's changed is we've had a really excellent conversation with the FDA about their desire to see. Subject to us continuing to produce really strong results in terms of efficacy and safety. Their desire to see this moved more quickly. We've completed the enrollment in our second final stage study, which we did ahead of expectations, which is really down to the phase three. This is a phase three. This is the second of our final stage studies. We've completed the enrollment of that. We expect to have the primary data from that in first quarter of next year. That will give us the second of our final stage studies. And with that, we are actually excited to be able to submit that to the agency and look to an accelerated approval.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Wow, that. That sounds like a really big move. I'm curious, just remind us, and we were talking with our, our health care team, how you guys designed the trials or research program to avoid some of the pitfalls that we've seen with, I think about the Ecstasy and the MDMA drug application, the PT that was for ptsd. How did you guys avoid some of those pitfalls?

[Kabir Nath]

So first we had the opportunity to learn from some of the lessons. We've been in an excellent dialogue with the FDA now for some six or seven years since we first started this time. Since this process. Yeah, as we know, drug developing new medicines takes a long time and a lot of commitment. Yeah, we've done this in a very robust and rigorous way. We are collecting full side effect data. We're collecting all the issues, not just your potential side effects such as headache and fatigue, which are transient, but also things like liking and so on, to make sure that there is really no abuse potential for this. And we've been collecting that right from the beginning.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Is there any abuse potential for this?

[Kabir Nath]

There is no history in psilocybin of people actually seeking it out or of any abuse potential with psilocybin, which is an important point.

[Tim Stanovec]

I'm putting my investor hat on for a moment and I need to ask you about intellectual property and how you handle something like that, because psychedelic compounds don't sort of fit comfortably into that compound, if you will, because a lot of them are natural. They can't really be patented, if you will. So how do you deal with that? And to what extent is your medicine, you know, hold patents or have intellectual property?

[Kabir Nath]

So our medicine comp360 is a fully synthetic formulation of psilocybin.

[Tim Stanovec]

Okay.

[Kabir Nath]

We have polyformor patents that address that. And therefore we have robust protection till 2038 with the potential for extension around that. Because again, we went for a fully synthetic modern medicine.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Have you talked directly with the Health and Human.

Secretary, Robert F. Kennedy?

[Kabir Nath]

We are focused on an excellent relationship with the psychiatry division of the fda.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Okay.

[Kabir Nath]

We've been working with the same folks for seven years.

[Co-host (possibly Carol Massar or another Bloomberg host)]

He has certainly made some commentary around this that has given, you know, hopes and expectations that this would move along more rapidly.

[Kabir Nath]

We're happy that there are senior figures in the administration who believe like us in the potential for psychedelic therapy, but we're really focused on delivering the right efficacy and safety through our studies and working directly with the division that's going to approve us.

[Tim Stanovec]

So trial three, third phase, next year, early next year. Give us an idea of a timeline. I mean, when might we see something like this come to market?

[Kabir Nath]

We will get the primary data, as I said, in first quarter of next year.

[Tim Stanovec]

Right.

[Kabir Nath]

We will need to submit some more data later in the year, but we are looking forward to being in a position to complete a submission to the FDA in the latter part of next year. And then we'll work with them as expedition as possible on a potential regulatory approval.

[Co-host (possibly Carol Massar or another Bloomberg host)]

So 2026, 2027. Like, what's. I know this stuff all takes long and I know we constantly am asking you, but I think because it's been so much out there for a while, a decade and then some. Right. I think we're all trying to, certainly for an investing audience, understand when this actually hits, hits the market.

[Kabir Nath]

We are preparing to be ready for a commercial launch from the end of 2026.

[Tim Stanovec]

Oh, he said it. Well, thank you.

[Co-host (possibly Carol Massar or another Bloomberg host)]

What is something like this? Yeah, what is something like this? Cost?

[Tim Stanovec]

That's the question.

[Kabir Nath]

So it's premature to discuss the pricing for this at the moment. First, we actually still need to see some of the longer term results from our studies.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Right.

[Kabir Nath]

In particular, we need to see over the course of the first six months what the potential for a second dose is and really therefore how many potential sessions that a patient may need to have in a given year.

[Tim Stanovec]

That's a great question because you're talking sessions. So this is not a drug that someone would continue to take or a lifelong sort of drug, if you will.

[Kabir Nath]

Absolutely. And it's a really important point there. What we have shown in our study so far is that a single session can produce a dramatic response that lasts for six weeks. Today, either it's a daily oral or there is a product, esketamine, which you will need to take maybe 30 to 50 times a year. What we are showing is truly transformative, therefore, for these patients with this infrequent sessions.

[Co-host (possibly Carol Massar or another Bloomberg host)]

We're talking with Kabir Nath. He's chief executive officer of Compass Pathways Ticker is cnp. He's here in our Bloomberg studio, Bloomberg headquarters. Kabir, one of the things I think about then is if all goes as you anticipate and you've talked about the market for like, who this is for specifically, then do you move on to other uses and other treatments, whether it's ptsd, whether it's drug addiction, Like, I'm just curious how far you can go with this.

[Kabir Nath]

Yes. Thank you, Carol. And we are designing, have in fact already designed and finalized the design of a study in PTSD. PTSD affects 13 million people in America. And while there's this view that it's prevalent among veterans and so on, it absolutely is. That's actually only around 15% of that population.

[Tim Stanovec]

Only 15%.

[Kabir Nath]

15%. Actually 60% of people suffering with PTSD are women. And so this is a very large population. The only two drugs, medicines approved for PTSD were approved in the last century. So this we could use something new, something different. And so we are very excited about that. We have designed a study and that we will be kicking that off next year.

[Tim Stanovec]

I want to go back to the question of price.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Sure.

[Tim Stanovec]

What about insurance and how does that play a part in all of this.

[Kabir Nath]

From the get go? Compass was set up in order to ensure broad and equitable access for patients. And that means the ability to work with insurers, both commercial and government. With the data we've already shown, as I say, a single administration producing statistically significant result reductions in depressive symptoms after six weeks. We've already started to demonstrate the Value that this can bring to the health care system. Patients living with persistent depression frequently end up in the emergency room. They sometimes have inpatient psychiatric care. There are direct costs to health care systems. And we have already started to demonstrate the value.

[Co-host (possibly Carol Massar or another Bloomberg host)]

You know, and forgive us, Kabir, we do keep going back to. I know you can't talk about price or your guys are figuring that out, but we kicked off saying, according to our Bloomberg intelligence team, that this market psychedelic drug development could grow to $7 billion in sales by 2032. How much of that do you think is or how much of that market size do you think you could get? And I'm just trying to. I'm curious.

[Kabir Nath]

So we have the potential to be ahead of other companies in this market by two to three years. And we're excited about the opportunity to treat lots of patients. So for us, this is about the ability to make inroads into those 3 million patients that need a new treatment option. The only medicine that's actually approved and is being really promoted for this population today is treating maybe 70 to 100,000 patients over that population of 3 million.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Right.

[Kabir Nath]

So what we're excited about is the ability to bring this new medicine to those patients.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Is it a billion dollar drug? Would you anticipate?

[Kabir Nath]

We would hope that if we can successfully treat. If we can treat a large number of patients.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Well, especially if you get. And you expand out.

[Tim Stanovec]

Do you call for other uses?

[Carol Massar]

Yeah.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Do you go alone?

[Kabir Nath]

That's our intention. We've always said clearly that we believe that we can do this on our own in the US market. And that's our intention.

[Tim Stanovec]

All right. What about side effects? I mean, folks are listening to this. A lot of folks are hoping that this is all going to work and come to market sooner rather than later. What are some of the side effects, though?

[Kabir Nath]

So on the day of dosing, there's some headache, some nausea, and that passes by the second day at most. Because this is a day in a treatment center. We have a fully independent group of scientists and clinicians that reviews all our safety data on a regular basis. They have access to data from all arms of our studies and they have seen no unexpected or concerning side effects that have caused them to alter the course of the study in any way.

[Co-host (possibly Carol Massar or another Bloomberg host)]

And just remind everybody. And we just got about 40 seconds. Kabir.

[TV Show Promo Announcer]

Right.

[Co-host (possibly Carol Massar or another Bloomberg host)]

When it is given to a patient, there are folks around to really watch the process, make sure things go.

[Tim Stanovec]

You're not taking this in your bathroom by yourself?

[Kabir Nath]

No, this is very much delivered in a safe environment in a medical environment with somebody in the room who is medically trained, who's there just to assure patient safety and comfort.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Do you see the finish line?

[Kabir Nath]

I absolutely do and we're excited about that potential.

[Co-host (possibly Carol Massar or another Bloomberg host)]

I just think how long we've been reporting on it and talking about it. It's really fun to kind of be on this journey somewhat with you.

[Tim Stanovec]

I'm just wondering quickly, regulatory hurdles in 2026, do you think that it's going to be a more friendly regulatory environment.

[Kabir Nath]

With the psychiatry division? We have an excellent relationship and that's been consistent over six, seven years and we expect that.

[Co-host (possibly Carol Massar or another Bloomberg host)]

Yeah. Sounds like you've been talking to them for a long, long time. Kabir. Thank you. Nice to have you in studio. Kabir Nath, he's chief Executive officer of Compass Pathways, joining us right here.

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[Kabir Nath]

Com.