Compass Pathways Announces FDA Acceptance of IND Application for PTSD

Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COMP360, enabling the initiation of a late-stage clinical trial in patients with PTSD. Compass management, along with KOL and industry leaders, will host a webinar today to discuss the company’s clinical trial plans for PTSD, as well as commercial preparations for treatment-resistant depression (TRD) from 10:00-11:30 am ET on January 7th.

“PTSD is one of the most challenging mental health conditions, with approximately 13 million adults in the U.S. living with persistent symptoms and limited treatment options,” said Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways. “We are pleased to advance our clinical development - the unmet need is profound, and it demands bold innovation. We believe COMP360 has the potential to transform the treatment landscape for PTSD and bring hope to those who need it most.”

“We enter 2026 with excitement and strong momentum, driving innovation to address critical needs in both PTSD and TRD,” said Kabir Nath, Chief Executive Officer at Compass Pathways. “As our commercialization plans advance, our focus is on ensuring seamless access to COMP360 for patients living with TRD, if approved. We look forward to continuing our close collaboration with the FDA and remain committed to generating robust clinical evidence with scientific rigor as we move into this next chapter.”

Late-Stage Clinical Trial for PTSD

• U.S FDA has accepted IND application for COMP360 in PTSD, enabling the initiation of a Phase 2b/3 (COMP202) clinical trial in patients living with PTSD.
• The phase 2b/3 multicenter, randomized, double-blind, controlled study, with an open label extension, aims to investigate the efficacy, safety, and tolerability of COMP360 in participants with PTSD.
• The study is comprised of 2 parts:
  • Part A (blinded) is a 12-week fixed repeat-dose, double-blinded, controlled part to confirm the efficacy of two administrations of COMP360 25 mg versus two administrations of COMP360 1 mg. The second COMP360 administration session will occur approximately 4 weeks later. The primary efficacy endpoint is the change from baseline in CAPS-5 total severity score at Week 8.
  • Part B (open-label) is a 40-week open-label follow-up to evaluate the long-term safety and efficacy of treatment in Part A. Eligible participants will receive a single open label retreatment with COMP360 25 mg. In both Part A and Part B, COMP360 may be administered adjunctively to a single permitted oral antidepressant.
• Previous Phase 2 open-label, safety and tolerability study in PTSD showed COMP360 was generally safe and well-tolerated and demonstrated both rapid and durable improvement in symptoms from baseline observed following a single administration out to 12 weeks. The results of this study were published in the September 2025 issue of the Journal of Psychopharmacology.

Commercialization Readiness in TRD

• Compass’ strategic collaborations continue to yield valuable learnings about how COMP360 psilocybin treatment will seamlessly integrate into various healthcare settings. Compass recently added Radial, a national network of clinics delivering interventional, evidence-based treatments for mental health conditions, as its seventh collaboration
• Positive Type B meeting with the FDA in September 2025 to discuss the Company’s NDA submission strategy for COMP360 in TRD and potential acceleration scenarios, including rolling submission. To facilitate rolling submission and review, Compass is disclosing second phase 3 trial (COMP006) 9-week (Part A) data together with 6-week (Part A) and 26-week (Part B) of COMP005 in the second half of Q1 2026
• 26-week (Part B) data from COMP006 is expected in early Q3 2026

Financial Updates

• Compass amended its existing term loan facility with Hercules Capital, Inc. (NYSE: HTGC), increasing the overall size to up to $150 million, of which $50 million have been drawn down under the amended loan facility as of closing. The remainder is available subject to meeting certain conditions specified in the Loan Agreement. The amendment extends the interest-only period from January 2, 2026 until at least January 5, 2029, with further extensions subject to the achievement of specified milestones, and extends the maturity date from July 1, 2027 to January 5, 2031
• This transaction provides further flexibility to the balance sheet and continues to maintain cash into 2027

January 7th PTSD & TRD Webinar - 10:00 am – 11:30 am ET

Webinar Overview:

• The discussion will feature perspectives from KOLs, industry leaders, and Compass management on the treatment landscape and unmet needs in TRD and PTSD, patient care pathways, growing interventional psychiatry infrastructure, and evolving treatment models
• Compass management team will also cover commercial readiness activities, the emerging profile of COMP360 in TRD, and plans for the late-stage PTSD program

Speakers include:

• Gary Small, MD, Director of Behavioral Health Therapies, Hackensack Meridian Health
• Geoffery Grammer, MD, CMO at Greenbrook Mental Wellness Centers
• Myriam Barthes, co-founder and CEO at Journey Clinical
• Dimitri Cavathas, CEO at HealthPort

Access:

• A live audio webcast of this event will be accessible at this link: https://lifescievents.com/event/q0v8tp3/. A replay of the webcast will be accessible for 30 days following the event.

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