Compass Pathways nears NDA filing for psilocybin depression therapy, reports Q3 results
Compass said its rolling NDA for COMP360 in treatment-resistant depression will be completed within two weeks, with launch still targeted for the first half of 2027.
Compass Pathways plc reported third quarter 2026 results on November 3, 2026, alongside an update on its lead program, COMP360 psilocybin, in treatment-resistant depression (TRD). The company said its rolling New Drug Application submission is nearing completion, with rolling review underway, and the final submission will be filed within the next two weeks.1
Compass pointed to 52-week open label data from the COMP005 trial and 6-month data from COMP006, saying the data showed added benefit from an additional COMP360 25 mg dose during Part C that extended durability out to one year, and that COMP360 demonstrated a generally well-tolerated and safe profile.1 The company reiterated that launch readiness remains on track for the first half of 2027, subject to FDA approval.1
On the regulatory front, Compass cited potential for accelerated review given a National Priority Voucher that could shorten review to 1-2 months, and a White House Executive Order directing the DEA to conduct a timely review to support rescheduling following successful Phase 3 data.1 The company also said its late-stage PTSD trial, designed to be registration-enabling, is underway, and that it is working with the U.S. Department of Veterans Affairs on a multi-site randomized controlled trial evaluating COMP360 in TRD veterans, including those with concurrent PTSD.1
On finances, cash and cash equivalents were $444.0 million as of September 30, 2026, compared with $149.6 million as of December 31, 2025.1 Compass said this cash position is expected to fund its operations and capital needs into 2028.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.