Developer · CMPS · United Kingdom
COMPASS Pathways plc
COMPASS Pathways is a biotechnology company developing COMP360, a synthesized (synthetic) psilocybin treatment being investigated for treatment-resistant depression and other serious mental health conditions. Its lead program, COMP360, has FDA Breakthrough Therapy designation and met its primary endpoint in two Phase 3 treatment-resistant depression trials (COMP005 and COMP006).
Pipeline (1)
- Treatment-resistant depressionPhase 3Active
- Anorexia nervosaPhase 2Completed
- Major depressive disorderPhase 2Active
- Post-traumatic stress disorderPhase 2/3Active
Deals & partnerships
- Feb 18, 2026FinancingCOMPASS Pathways prices $150M public offering of ADSs and pre-funded warrantsPriced an underwritten public offering of 17,500,000 ADSs at $8.00/ADS plus pre-funded warrants for up to 1,250,000 additional ADSs; gross proceeds ~$150.0 million, closing on/about 2026-02-20. Proceeds earmarked for the COMP005/COMP006 TRD trials, the PTSD Phase 2b/3 trial, and commercial-readiness activities.
- Jan 6, 2026PartnershipCOMPASS Pathways establishes strategic collaboration with Radial HealthSeventh strategic commercial collaboration for COMPASS Pathways, with Radial Health, Inc. (a national interventional-psychiatry clinic network operating in five states), to help inform a scalable delivery model for COMP360 psilocybin treatment pending FDA approval.
- Jan 5, 2026FinancingCOMPASS Pathways amends Hercules Capital loan facility to up to $150MThird Amendment to the Hercules Capital loan and security agreement establishes five term-loan tranches totaling up to $150.0 million; a $50.0 million Tranche 1 advance was funded at closing (partly repaying ~$31.1 million outstanding under the prior facility), with later tranches gated on clinical, FDA-approval, and commercial milestones.
Catalysts · 4 upcoming · 3 reported
- after primary completion (Nov 2024)Delayed
Psilocybin (COMP360)forAnorexia nervosaTopline data
Phase 2 anorexia nervosa proof-of-concept (NCT05481736) completed Nov 2024; topline EDE result not yet disclosed.
- September 2025Anticipated
Psilocybin (COMP360)forMajor depressive disorderTopline data
Phase 2 COMP360 recurrent-MDD topline anticipated (estimated primary completion Sep 2025); no results reported yet.
- third quarter 2026Anticipated
Psilocybin (COMP360)forPost-traumatic stress disorderRegulatory
Pivotal Phase 2b/3 PTSD trial (REDEFINE / NCT07570654) planned to start; FDA accepted the IND on 2026-01-07.
- fourth quarter 2026Anticipated
Psilocybin (COMP360)forTreatment-resistant depressionRegulatory
Full NDA submission targeted (FDA rolling review underway).
Recently reported
- 2026-02-17met
Psilocybin (COMP360)forTreatment-resistant depressionTopline data
COMP006 met its primary endpoint: -3.8 MADRS (two 25mg doses vs 1mg) at Week 6 (p<0.001).
- 2025-06-23met
Psilocybin (COMP360)forTreatment-resistant depressionTopline data
COMP005 met its primary endpoint: -3.6 MADRS vs placebo at Week 6 (p<0.001).
- 2024-11-19met
Psilocybin (COMP360)forPost-traumatic stress disorderTopline data
Open-label Phase 2 PTSD study showed durable CAPS-5 improvement through 12 weeks (-29.5 points from a 47.5 baseline) after a single 25mg dose; no serious adverse events.
Recent activity
- Apr 24, 2026Phase changePsilocybin (COMP360)·Treatment-resistant depressionPhase 3FDA granted rolling NDA review; Compass awarded Commissioner's National Priority Voucher.source ↗
- Feb 17, 2026ReadoutPsilocybin (COMP360)·Treatment-resistant depressionmetCOMP006 met its primary endpoint: -3.8 MADRS (two 25mg doses vs 1mg) at Week 6 (p<0.001).source ↗
- Jan 7, 2026Phase changePsilocybin (COMP360)·Post-traumatic stress disorderPhase 2/3FDA accepted the IND for COMP360 in PTSD, enabling the late-stage Phase 2b/3 'REDEFINE' program (two administrations 25mg vs 1mg; CAPS-5 to Week 8). Trial NCT07570654 registered as not-yet-recruiting (planned start Sep 2026).source ↗
- Jun 23, 2025ReadoutPsilocybin (COMP360)·Treatment-resistant depressionmetCOMP005 met its primary endpoint: -3.6 MADRS vs placebo at Week 6 (p<0.001).source ↗
- Nov 19, 2024ReadoutPsilocybin (COMP360)·Post-traumatic stress disordermetOpen-label Phase 2 PTSD study showed durable CAPS-5 improvement through 12 weeks (-29.5 points from a 47.5 baseline) after a single 25mg dose; no serious adverse events.source ↗
- Nov 18, 2024Phase changePsilocybin (COMP360)·Anorexia nervosaPhase 2NCT05481736 reached primary completion / overall completion (actual). 32 participants enrolled. No topline results disclosed as of mid-2026.source ↗
- Jan 30, 2023Phase changePsilocybin (COMP360)·Major depressive disorderPhase 2Phase 2 study of COMP360 in recurrent MDD (NCT05733546) started; first participant enrollment window opened.source ↗
- Oct 12, 2022Phase changePsilocybin (COMP360)·Anorexia nervosaPhase 2Phase 2 proof-of-concept trial NCT05481736 started (first participant period); randomised 25mg vs 1mg COMP360 with psychological support, primary endpoint EDE global score at Week 4. Launch announced 28 Jul 2022.source ↗
Competitive landscape
Other companies developing against COMPASS Pathways plc's targets or indications.
- Beckley Psytech Limited2 compounds5-HT2ATreatment-resistant depressionMajor depressive disorder
- Definium Therapeutics, Inc.1 compound5-HT2AMajor depressive disorderPost-traumatic stress disorder
- Alto Neuroscience, Inc.3 compoundsTreatment-resistant depressionMajor depressive disorder
- Atai Beckley N.V. (AtaiBeckley)1 compound5-HT2ATreatment-resistant depression
- Delix Therapeutics, Inc.1 compound5-HT2AMajor depressive disorder
- GH Research PLC1 compound5-HT2ATreatment-resistant depression
- Gilgamesh Pharmaceuticals, Inc.2 compounds5-HT2AMajor depressive disorder
- Helus Pharma2 compounds5-HT2AMajor depressive disorder
- Intra-Cellular Therapies, Inc.2 compounds5-HT2AMajor depressive disorder
- Mindset Pharma Inc.1 compound5-HT2AMajor depressive disorder
- Otsuka Pharmaceutical Co., Ltd.3 compoundsMajor depressive disorderPost-traumatic stress disorder
- Taisho Pharmaceutical Co., Ltd.2 compoundsTreatment-resistant depressionMajor depressive disorder
