Biotechnology company Compass Pathways plc (Nasdaq:CMPS) said on Monday that it has completed its New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) for COMP360, its investigational synthetic psilocybin formulation for the treatment of treatment-resistant depression (TRD).

The submission is supported by data from two statistically significant Phase 3 trials and a Phase 2b study, all of which met their primary endpoints and collectively involved more than 1,000 participants with chronic TRD.

The company said its commercial infrastructure is in place to support a potential launch and broad patient access, with preparations targeting the first half of 2027, subject to FDA approval.

Compass Pathways estimates that approximately four million people in the United States live with TRD, defined as depression that has not responded adequately to at least two courses of antidepressant treatment.