Compass Pathways reports Q2 2026 results, cites Phase 3 data as NDA filing nears

Compass Pathways plc reported second quarter and first half 2026 results on August 5, 2026, pointing to its ongoing regulatory filing for COMP360 psilocybin in treatment-resistant depression (TRD). The company said the FDA granted Compass a rolling NDA submission and review request in April, based on the strength of positive Phase 3 data, and that submission and initial review are now underway, with some modules already submitted and all modules on track for completion in the fourth quarter.¹

Compass also noted it received a National Priority Voucher for COMP360, which the company said has the potential to shorten filing review time to one to two months.¹ Separately, the company pointed to a White House executive order directing the DEA to review rescheduling of psychedelic treatments that have completed Phase 3 trials.

On the clinical side, Compass highlighted results from its two Phase 3 trials, COMP005 and COMP006. Across the studies, 39% of participants in COMP006 and 25% in COMP005 achieved a reduction in MADRS depression scores of at least 25% at Week 6, with benefit maintained on average through at least Week 26.¹ The company described the safety profile as generally well tolerated, with the vast majority of treatment-emergent adverse events being transient and occurring mostly on the day of dosing, and serious adverse events reported as low overall across both trials.¹

Compass said commercial launch, if approved, is expected in the first half of 2027, subject to FDA approval and following DEA rescheduling.¹ The company also said its PTSD program continues, with a late-stage trial underway.¹

On finances, cash and cash equivalents were $433.3 million as of June 30, 2026, compared with $149.6 million as of December 31, 2025.¹ Compass said its current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028.¹