COMPASS Pathways (CMPS) Company Report

Compass Pathways plc (CMPS) announced the successful achievement of the primary endpoint in its Phase 3 COMP006 trial for COMP360, a synthetic psilocybin formulation for treatment-resistant depression (TRD).
The trial demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.8 points in MADRS scores for the 25 mg dose at Week 6.
COMP360 showed a generally well-tolerated and safe profile with rapid onset of effect, and durable treatment effects were observed through Week 26 in the COMP005 trial.

4 days ago

Press Release

Compass Pathways Prices $150 Million Public Offering

CMPS

Compass Pathways plc announced the pricing of its public offering, which includes 17,500,000 American Depositary Shares (ADSs) at $8.00 per ADS and 1,250,000 pre-funded warrants at $7.9999 per pre-funded warrant.
The offering is expected to generate $150.0 million in gross proceeds for Compass Pathways.
The company intends to use the net proceeds, along with existing cash, to fund ongoing COMP005 and COMP006 Phase 3 trials, its Phase 2b/3 trial of COMP360 in PTSD, accelerate commercial readiness activities, and for working capital and general corporate purposes.
The offering is anticipated to close on or about February 20, 2026.

Feb 19, 2026, 1:50 PM

8-K

Compass Pathways Announces Pricing of Public Offering

CMPS

New Projects/Investments

Compass Pathways announced the pricing of a public offering for 17,500,000 American Depositary Shares (ADSs) at $8.00 per ADS and pre-funded warrants to purchase up to 1,250,000 ADSs at $7.9999 per pre-funded warrant.
The offering is expected to generate $150.0 million in gross proceeds for the company.
Net proceeds from the offering are intended to fund ongoing COMP005 and COMP006 Phase 3 trials, a Phase 2b/3 trial of COMP360 in PTSD, accelerate commercial readiness activities, and for working capital and general corporate purposes.
The offering is anticipated to close on or about February 20, 2026.

Feb 19, 2026, 1:18 AM

Press Release

Compass Pathways Launches Proposed Public Offering

CMPS

Compass Pathways plc announced the launch of a proposed public offering of $150.0 million in American Depositary Shares (ADSs) and pre-funded warrants to purchase ADSs.
The company expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of ADSs.
Jefferies, TD Cowen, Cantor, and Stifel are acting as joint book-runners for the proposed offering.
The proposed offering is subject to market and other conditions, with no assurance as to whether or when it may be completed, or its actual size or terms.

Feb 17, 2026, 9:06 PM

Press Release

COMPASS Pathways Reports Positive Phase 3 COMP360 Results and Targets Year-End Launch

CMPS

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

COMPASS Pathways announced positive results from its COMP360 phase 3 COMP005 and COMP006 pivotal trials for treatment-resistant depression (TRD), having met primary endpoints with high statistical significance in three consecutive trials.
COMP360 demonstrated rapid onset of action and durable efficacy, with 25% of patients in COMP005 achieving a clinically meaningful reduction in symptoms by week six, sustained through 26 weeks, and 39% of patients in COMP006.
The company has submitted the data to the FDA and requested a meeting to discuss an NDA filing strategy, including a potential rolling submission and expedited review due to breakthrough designation.
COMPASS Pathways anticipates being launch-ready by the end of this year, with the 26-week COMP006 data (expected in early Q3) being the final gating item for the NDA package.
COMP360 is positioned as a highly differentiated, first-in-class treatment for TRD with blockbuster potential, given its rapid onset, durability, and well-tolerated safety profile.

Feb 17, 2026, 1:00 PM

Transcript

COMPASS Pathways Announces Positive Phase 3 Results for COMP360 in TRD

CMPS

Product Launch

New Projects/Investments

On February 17, 2026, COMPASS Pathways announced highly statistically significant positive Phase 3 trial results for COMP360 in Treatment Resistant Depression (TRD) from two trials, COMP005 and COMP006.
The trials demonstrated an extremely rapid onset of action, with statistical significance from the day immediately following administration, and a deep and durable response, with 25% of participants in COMP005 achieving a clinically meaningful reduction in MADRS at Week 6 with durability lasting at least 26 weeks.
COMP360 was generally well-tolerated with a safe profile, and the majority of adverse events resolved on the day of treatment.
The company has Breakthrough Therapy designation from the FDA and plans to meet with the FDA to discuss a rolling submission, expecting to complete an NDA submission in Q4.
COMPASS Pathways is planning to be launch ready by the end of the year.

Feb 17, 2026, 1:00 PM

Presentation

COMPASS Pathways Announces Positive Phase III Trial Results for COMP360 and Plans for 2026 Launch

CMPS

Product Launch

New Projects/Investments

Compass Pathways announced positive results from its COMP360 Phase III COMP005 and COMP006 pivotal trials for treatment-resistant depression (TRD), meeting primary endpoints with high statistical significance.
COMP360 demonstrated rapid onset of action, with patients responding on day one, and a durable treatment effect sustained through 26 weeks after one or two administrations.
The company has submitted the data to the FDA and requested a meeting to discuss a rolling submission and expedited review, aiming for a launch by the end of 2026 if approved.
COMP360 is positioned as a highly differentiated, first-in-class treatment option for TRD, with potential for "blockbuster potential".

Feb 17, 2026, 1:00 PM

Transcript

COMPASS Pathways Announces Positive Phase 3 Trial Results for COMP360 in Treatment-Resistant Depression and Plans for 2026 Launch

CMPS

Product Launch

New Projects/Investments

COMPASS Pathways announced positive results from its COMP360 phase 3 COMP005 and COMP006 pivotal trials for treatment-resistant depression (TRD), meeting primary endpoints with high statistical significance in both studies.
COMP360 demonstrated rapid onset of action, with patients responding on day one, and durability, with clinically meaningful reductions in symptoms sustained through 26 weeks after one or two administrations.
The treatment was found to be generally well-tolerated with a safe profile, with most adverse events resolving on the day of treatment and no new safety signals identified across over 1,000 patients.
The company plans to submit the data to the FDA, request a meeting to discuss its NDA filing strategy (including potential for rolling submission and expedited review due to breakthrough designation), and aims for a commercial launch by the end of 2026.

Feb 17, 2026, 1:00 PM

Transcript

COMPASS Pathways Reports Positive Phase 3 Results for COMP360 in TRD and Plans Q4 NDA Submission

CMPS

Product Launch

New Projects/Investments

Guidance Update

COMPASS Pathways announced positive results from two statistically significant Phase 3 trials (COMP005 and COMP006) for COMP360 in Treatment Resistant Depression (TRD), demonstrating rapid onset of action and sustained durability for at least 26 weeks after one or two doses.
COMP360 has received Breakthrough Therapy designation from the FDA, and the company plans to meet with the FDA to discuss a rolling submission and review.
The company expects to complete its New Drug Application (NDA) submission for COMP360 in Q4 and is planning to be launch ready by the end of the year.
The safety profile of COMP360 was generally well-tolerated, with most treatment-emergent adverse events resolving on the day of treatment and no new safety signals identified.

Feb 17, 2026, 1:00 PM

Presentation

COMPASS Pathways Announces Positive Phase 3 COMP006 Trial Results for COMP360 in TRD

CMPS

New Projects/Investments

Product Launch

COMPASS Pathways announced the successful achievement of the primary endpoint in its Phase 3 COMP006 trial for COMP360 in treatment-resistant depression (TRD) on February 17, 2026, demonstrating a highly statistically significant reduction in symptom severity (p<0.001) at Week 6.
The COMP360 program has shown rapid onset of action and durable treatment effects through at least Week 26 in COMP005, with a generally well-tolerated and safe profile across both COMP005 and COMP006 trials.
The company has requested a meeting with the U.S. FDA to discuss a rolling submission and review for COMP360, which holds Breakthrough Therapy designation, and anticipates completing a New Drug Application (NDA) submission in Q4.
TRD affects millions of U.S. adults annually, with only two approved medicines, highlighting a significant unmet need that COMP360 aims to address.