COMPASS Pathways (CMPS) Company Report

Compass Pathways announced the pivotal phase II-B/III trial design for its COMP360 program in Post-Traumatic Stress Disorder (PTSD), with patient screening expected to begin this quarter. The trial will test two doses of 25 mg of COMP360 against a 1 mg active control.
The company has accelerated its launch timelines for COMP360 in Treatment-Resistant Depression (TRD) and expects to be launch-ready by the end of this year.
COMP360 for TRD is positioned as a differentiated treatment option due to its rapid and durable symptom reduction after a single administration, in contrast to Spravato's frequent dosing, and will benefit from new CPT codes for hourly reimbursement.
Key upcoming data readouts include 006 Part A (6-week primary endpoint) and 005 Part B (26-week) data in Q1, and 006 Part B (26-week) data in early Q3 of this year, which is anticipated to be the last gating item for NDA submission.

2 days ago

Transcript

COMPASS Pathways Updates on COMP360 Programs and Commercial Readiness

CMPS

Product Launch

New Projects/Investments

COMPASS Pathways announced the pivotal phase 2b/3 trial design for its COMP360 program for Post-Traumatic Stress Disorder (PTSD), with patient screening anticipated to begin in Q1 2026. The company also accelerated its launch timelines for the Treatment-Resistant Depression (TRD) program, aiming to be launch-ready by the end of 2026.
COMP360 for TRD is positioned to offer rapid and durable symptom reduction after a single dose, demonstrating comparable six-week efficacy to Spravato but requiring significantly fewer administrations (one vs. ten).
Commercial preparations are well underway, with approved CPT codes for hourly reimbursement of psychedelic treatments and an existing interventional psychiatry infrastructure of over 6,800 sites ready to integrate COMP360.
Key upcoming data readouts include Q1 2026 for 006 part A (efficacy and safety) and 005 part B (26-week data), with 26-week data from 006 part B expected in early Q3 2026, which will inform dosing for labeling and complete the NDA submission.

2 days ago

Transcript

COMPASS Pathways Accelerates TRD Launch Timelines and Announces Pivotal PTSD Trial Design

CMPS

Product Launch

New Projects/Investments

Guidance Update

COMPASS Pathways has accelerated its launch timelines for COMP360 in Treatment-Resistant Depression (TRD), aiming to be launch-ready by the end of 2026, following early enrollment completion for its 006 trial and the FDA's openness to a rolling submission.
The company announced the design of its pivotal phase 2b/3 trial for COMP360 in Post-Traumatic Stress Disorder (PTSD), which will test two doses of 25mg against 1mg as an active control, with patient screening anticipated to begin in Q1 2026.
In Q1 2026, COMPASS expects to report pivotal efficacy and safety data from part A of the 006 trial and 26-week part B data from the 005 trial for TRD, which will help inform clinical decision-making and payer discussions.
COMP360 for TRD is expected to offer rapid and durable results after one initial administration, providing a significant differentiation from the 10 administrations required by Spravato over a six-week period.

2 days ago

Transcript

Compass Pathways Provides Update on COMP360 Clinical Programs for TRD and PTSD

CMPS

New Projects/Investments

Guidance Update

Product Launch

Compass Pathways (CMPS) is developing COMP360 for Treatment-Resistant Depression (TRD) and Post-Traumatic Stress Disorder (PTSD).
The COMP005 Phase 3 trial for TRD met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful reduction in symptom severity with a single 25 mg administration of COMP360 compared to placebo. The FDA supports a rolling NDA submission for COMP360 in TRD.
Key data readouts for TRD trials include Part A data from COMP006 in Q1 2026, Part A and B data from COMP005 in Q1 2026, and Part B data from COMP006 in early Q3 2026. A Phase 3 trial for PTSD is also expected to commence in Q1 2026.
The company reported a cash position of $186 million as of September 30, 2025, which is expected to provide a cash runway into 2027.

2 days ago

Presentation

COMPASS Pathways Provides Update on COMP360 Clinical Development and Financial Position

CMPS

New Projects/Investments

Guidance Update

Product Launch

COMPASS Pathways (CMPS) is advancing COMP360, a proprietary psilocybin treatment, through late-stage clinical development for Treatment-Resistant Depression (TRD) and Post-Traumatic Stress Disorder (PTSD).
Key near-term value drivers include Part A (9-week) data from COMP006 and Part A (6-week) and Part B (26-week) data from COMP005 for TRD, both expected in Q1 2026. Additionally, Part B (26-week) COMP006 data is anticipated in early Q3 2026.
The company reported a strong cash position of $186 million as of September 30, 2025, providing a cash runway into 2027.
The FDA is supportive of a rolling submission and review of the planned NDA filing for COMP360 in TRD.

3 days ago

Presentation

COMPASS Pathways plc Amends Loan Agreement, Securing Up to $150 Million

CMPS

Debt Issuance

COMPASS Pathways plc entered into a Third Amendment to its Loan and Security Agreement with Hercules Capital, Inc. on January 5, 2026.
This amendment replaces the previous $50,000,000 term loan facility with a new facility providing up to $150,000,000 in term loans.
The borrowings are collateralized by the Borrowers' personal property and other assets, excluding certain intellectual property rights and deposit accounts.
The agreement includes financial covenants requiring the maintenance of minimum qualified cash levels, which can range from 35% to 85% of outstanding advances depending on milestone achievement, and a performance covenant tied to net product revenue after FDA approval. These covenants can be waived under specific market capitalization or unrestricted cash conditions.
The term loan maturity date is January 5, 2031.

3 days ago

8-K

Compass Pathways Announces FDA IND Acceptance for PTSD and Amends Loan Facility

CMPS

Product Launch

New Projects/Investments

Debt Issuance

The FDA has accepted Compass Pathways' Investigational New Drug (IND) application for COMP360 for post-traumatic stress disorder (PTSD), allowing the initiation of a late-stage clinical trial.
Compass Pathways continues to advance commercial preparations for COMP360 for treatment-resistant depression (TRD), aiming to be launch-ready by year-end, and expects to disclose second phase 3 trial data in the second half of Q1 2026.
The company amended its term loan facility, increasing it to up to $150 million (with $50 million drawn), extending the interest-only period to at least January 5, 2029, and maintaining cash into 2027.

3 days ago

Press Release

Compass Pathways to Host Webinar on TRD Commercial Preparations and PTSD Clinical Trial Plans

CMPS

New Projects/Investments

Product Launch

Compass Pathways will host a webinar on January 7, 2026, at 10:00 am ET to discuss commercial preparations for Treatment-Resistant Depression (TRD) and clinical trial plans for Post-Traumatic Stress Disorder (PTSD).
The event will feature collaboration partners discussing patient care pathways, provider economics for multi-hour treatments, and the development of treatment models in TRD.
Compass Pathways' management will review commercial readiness activities and the emerging profile of COMP360 in TRD, and provide details on the planned late-stage program for COMP360 in PTSD.
COMP360, an investigational synthetic psilocybin treatment, has received Breakthrough Therapy designation from the U.S. FDA and Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.

Dec 9, 2025, 11:30 AM

Press Release

CMPS Details Accelerated COMP360 NDA Submission and PTSD Program

CMPS

Guidance Update

New Projects/Investments

Product Launch

CMPS anticipates a rolling NDA submission and review process for COMP360 in Treatment-Resistant Depression (TRD) with the FDA. The primary endpoint data from the second Phase 3 study (006) is expected in Q1 2026, and the final piece of the NDA submission (long-term 6-month data from 006) is expected in early Q3 2026, potentially leading to a submission in the latter part of 2026 and a launch as early as the end of 2026. This represents a 9-12 month acceleration from previous expectations.
The commercial launch strategy for COMP360 will concentrate on the approximately 6,000 existing Spravato treatment centers, which are currently growing at 35%-40% year over year. These centers are deemed suitable for COMP360 administration.
In a Phase 2 open-label study for Post-Traumatic Stress Disorder (PTSD) involving 22 patients, a single dose of COMP360 resulted in remission in over 80% of patients, sustained in over 70% out to 12 weeks. CMPS has finalized the protocol for a late-stage, potentially registrational study for PTSD, with clinical execution planned for Q1 2026.
COMP360 demonstrated comparable efficacy to Spravato in 6 weeks with one day of treatment, significantly less than Spravato's requirement of 10 treatments over the same period, indicating a lower patient and caregiver burden.

Dec 3, 2025, 6:30 PM

Transcript

COMPASS Pathways Provides Update on COMP360 Development and Commercialization

CMPS

New Projects/Investments

Guidance Update

Product Launch

COMPASS Pathways anticipates a rolling NDA submission for COMP360 in Treatment-Resistant Depression (TRD), with primary endpoint data from the second Phase 3 study (006) expected in Q1 2026 and 26-week data in early Q3 2026.
This accelerated timeline could lead to an NDA submission in late 2026 and a potential launch as early as the end of 2026, representing a 9-12 month acceleration. The company expects a priority review.
COMP360 aims to achieve similar efficacy to Spravato with one treatment over six weeks compared to Spravato's ten treatments, addressing a market of 4 million eligible TRD patients.
In Post-Traumatic Stress Disorder (PTSD), a Phase 2 open-label study of COMP360 showed remission in over 80% of patients, sustained in over 70% for 12 weeks after a single dose.
A late-stage, potentially registrational PTSD study protocol will be announced in early 2026, with clinical execution starting in Q1 2026, targeting 13 million PTSD patients.