Compass Pathways Plc Stock Price, News & Analysis

Compass Pathways (NASDAQ: CMPS) has announced positive Phase 3 trial results for COMP360, its synthetic psilocybin treatment for Treatment-Resistant Depression (TRD). The COMP005 trial, involving 258 participants across 32 US sites, achieved its primary endpoint with a statistically significant reduction in depression symptoms. A single 25mg dose of COMP360 showed a clinically meaningful difference of -3.6 points versus placebo on the MADRS scale (p<0.001). The Independent Data Safety Monitoring Board reported no unexpected safety concerns or significant differences in suicidal ideation between treatment groups. This marks a historic milestone as the first Phase 3 efficacy data for synthetic psilocybin and any classic psychedelic. A second Phase 3 trial (COMP006) continues enrollment with results expected in H2 2026.

Compass Pathways (NASDAQ: CMPS), a biotech company focused on mental health innovation, has announced its participation in the 2025 RBC Capital Markets Global Healthcare Conference. The company's management will engage in a fireside chat on May 20th, 2025 at 10:30 am ET. Investors can access the live audio webcast through the "Events" page in the Investors section of Compass's website, with the replay remaining available for 30 days after the event.

Compass Pathways (NASDAQ: CMPS) reported its Q1 2025 financial results, highlighting significant progress in its psychedelic therapy development. The company reported a net loss of $17.9 million ($0.20 per share), an improvement from $35.2 million loss in Q1 2024. Key financial metrics include R&D expenses of $30.9 million, G&A expenses of $18.7 million, and a strong cash position of $260.1 million. The company's pivotal Phase 3 COMP360 psilocybin treatment program for Treatment Resistant Depression (TRD) is progressing well, with top-line 6-week data expected in late June. Recent 52-week data showed promising durability with a median time to depressive event of 92 days on a single 25mg dose. Additionally, Phase 2 results for PTSD treatment demonstrated positive safety and efficacy outcomes. The company's cash runway extends through the planned COMP006 26-week data readout in H2 2026.

Compass Pathways has partnered with HealthPort to explore delivering COMP360 synthesized psilocybin treatment in underserved communities. This strategic collaboration aims to address mental health treatment access barriers, particularly for patients with treatment-resistant depression (TRD).

HealthPort, a community health organization with 45 years of experience in Maryland's Eastern Shore, specializes in integrated care addressing social determinants of health. The partnership will:

• Research training and care reimbursement processes for COMP360
• Study implementation methods in community care settings
• Develop templates for future delivery systems

This collaboration expands Compass's network of partnerships across various healthcare settings in the United States. COMP360, their proprietary psilocybin formulation, is currently under investigation for treating difficult-to-treat mental health conditions, pending FDA approval.

Compass Pathways (Nasdaq: CMPS), a biotechnology company focused on mental health innovation, has scheduled its first quarter 2025 financial results announcement for May 8, 2025. The company will present its financial performance for the quarter ending March 31, 2025, along with recent business updates.

Management will host a conference call at 8:00 am ET (1:00 pm UK). Investors and interested parties can access the live webcast through the company's website, where it will remain archived for 30 days following the presentation.

Compass Pathways (NASDAQ: CMPS) has completed dosing all participants in Part A of its Phase 3 COMP005 trial, evaluating COMP360 psilocybin for treatment-resistant depression (TRD). The trial involved administering a single dose of either 25 mg COMP360 or placebo to participants following pre-dosing activities, including antidepressant medication washout where necessary.

The company remains on schedule to release top-line 6-week primary endpoint results in late June. This milestone represents significant progress in addressing unmet needs in treatment-resistant depression, demonstrating the company's commitment to scientific rigor and operational excellence in developing new treatment options for underserved patients.

Compass Pathways (NASDAQ: CMPS) has completed recruitment for its COMP005 phase 3 trial evaluating COMP360, a synthetic psilocybin treatment for treatment-resistant depression (TRD). Final participants are completing pre-dosing activities, including antidepressant medication washout where necessary.

The trial is part of the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line results for the 6-week primary endpoint are expected in late Q2 2025, while 26-week data will be available after all participants complete part A of the COMP006 trial, expected in second half 2026.

COMP360 is being investigated as a potential first-in-class psilocybin treatment for mental health conditions, administered with psychological support. TRD affects patients who don't respond adequately to at least two different treatments, with up to one-third of depression patients failing multiple treatment attempts.

Compass Pathways (NASDAQ: CMPS) has published results from its COMP004 study, a 52-week observational follow-up of Phase 2 trials evaluating COMP360 psilocybin for treatment-resistant depression (TRD). The study demonstrated that a single 25mg dose of COMP360 maintained antidepressant effects longer compared to lower doses.

Key findings show the median time to depressive event was 92 days for the 25mg group, versus 83 days (10mg) and 62 days (1mg). A post-hoc analysis revealed even more substantial differences, with 189 days for the 25mg group compared to 43 days (10mg) and 21 days (1mg).

The treatment was generally well-tolerated, with three participants reporting treatment emergent serious adverse events deemed unrelated to the study drug. The company expects top-line data from its ongoing Phase 3 COMP005 trial in Q2 2025, with 26-week COMP006 data anticipated in H2 2026.

Compass Pathways (Nasdaq: CMPS), a biotechnology company focused on mental health innovation, has announced its upcoming participation in the Stifel Virtual CNS Forum. The company's management will deliver a presentation on March 18th, 2025 at 11:30 am ET.

The presentation will be available through a live audio webcast on the 'Events' page within the Investors section of Compass's website. Interested parties can access a replay of the webcast for up to 30 days after the event.