LONDON & NEW YORK, August 6, 2026

Definium Therapeutics reported its second quarter 2026 financial results and recent business highlights, led by positive topline results from the Phase 3 Emerge study evaluating DT120 ODT in major depressive disorder (MDD). The company reported that the trial met its primary and all key secondary efficacy endpoints, with DT120 ODT demonstrating a statistically significant and clinically meaningful improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Definium also completed enrollment in two Phase 3 studies evaluating DT120 ODT in generalized anxiety disorder (GAD), with topline results from Voyage expected during the week of August 10, 2026, followed by Panorama results anticipated in September 2026. The company ended the quarter with approximately $1.1 billion in cash, cash equivalents, and investments, which it expects to support operations into 2030.

PIVOT Study to Evaluate COMP360 in Veterans with TRD

The PIVOT trial is designed as a multi-site, double-blind, randomized controlled study enrolling veterans diagnosed with treatment-resistant depression, with or without concurrent PTSD. The study will compare outcomes between two doses of COMP360 psilocybin, with the option for a second open-label administration four weeks after the initial dose. The primary efficacy endpoint will assess depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary assessments will examine PTSD symptom severity, tolerability, side effects, and patient-reported depression outcomes. The lead site is the Birmingham VA Health Care System in Alabama, with additional VA sites in Tuscaloosa, Portland, Seattle, and Philadelphia.

COMP360 Targets Significant Unmet Need in Veterans

Treatment-resistant depression remains a major challenge for patients who do not respond adequately to conventional antidepressant treatments. The burden can be particularly complex among veterans, where TRD and PTSD may occur together, potentially complicating treatment and recovery. The PIVOT study will provide an opportunity to evaluate COMP360 in a veteran population while simultaneously examining its potential impact on both depressive and PTSD symptoms. Compass is providing its proprietary, pharmaceutical-grade COMP360 synthetic psilocybin formulation, which is designed for stability and purity, along with training materials, administration guidance, and consultation for participating investigators and healthcare providers.

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Compass Expands Late-Stage COMP360 Development

The VA collaboration further expands Compass Pathways’ clinical development strategy for COMP360, which is being investigated as a potential new treatment option for TRD and PTSD. COMP360 has received FDA Breakthrough Therapy Designation for TRD, while Compass is also conducting late-stage development in PTSD. The PIVOT study could generate additional evidence regarding the potential role of psilocybin-assisted treatment in veterans with complex psychiatric conditions, particularly those experiencing depression alongside PTSD. However, the investigational therapy remains subject to clinical evaluation and regulatory review, and the study’s results will be required to determine its efficacy and safety in this population.

Source:Compass Pathwayspress release