Compass Pathways (NASDAQ:CMPS) reached a pivotal milestone on Wednesday, January 7, 2026, as the U.S. FDA accepted the company’s Investigational New Drug (IND) application for COMP360, its proprietary synthetic psilocybin treatment, for the treatment of Post-Traumatic Stress Disorder (PTSD).
The clearance greenlights the initiation of COMP202, a Phase 2b/3 clinical trial designed to bring the therapy to the roughly 13 million U.S. adults suffering from the condition.
The announcement was accompanied by a major commercial update for the company's lead indication, Treatment-Resistant Depression (TRD).
Following a successful meeting with the FDA in late 2025, Compass is accelerating its commercial readiness to be launch-ready by the end of 2026.
This timeline is supported by a "rolling submission" strategy for its New Drug Application (NDA), allowing the FDA to review portions of the data as they become available.
To fuel this aggressive expansion, Compass also significantly strengthened its balance sheet, amending its term loan with Hercules Capital to a total of $150 million.
The move extends the company’s cash runway into 2027, providing the financial flexibility needed to navigate the final regulatory hurdles for TRD while simultaneously launching its large-scale PTSD program.