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

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.

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."

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)

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

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.