Compass Pathways NASDAQ CMPS surges 10.92% as FDA accepts COMP360 IND application for PTSD treatment

Compass Pathways (NASDAQ: CMPS) surged 10.92% in pre-market trading on January 8, 2026, following the U.S. Food and Drug Administration’s (FDA) acceptance of its Investigational New Drug (IND) application for COMP360, a synthetic psilocybin treatment targeting post-traumatic stress disorder (PTSD). The approval allows the company to initiate a late-stage Phase 2b/3 clinical trial, marking a critical step in its development pipeline.

The FDA acceptance builds on prior positive data from a Phase 2 open-label study, which demonstrated COMP360’s safety and rapid symptom improvement in PTSD patients. Compass Pathways also announced a webinar on January 7, 2026, featuring key opinion leaders and industry experts to discuss clinical strategies for PTSD and commercial readiness for treatment-resistant depression (TRD). The company highlighted its Breakthrough Therapy designation for COMP360 in TRD and ongoing preparations for a potential 2026 launch.

With 13 million U.S. adults affected by PTSD annually and limited treatment options, Compass emphasized the unmet need for innovative therapies. The trial’s design includes a 12-week blinded phase to evaluate efficacy and a 40-week open-label extension for long-term safety. Meanwhile, the company continues advancing its TRD program, including a Type B meeting with the FDA in 2025 to explore accelerated regulatory pathways.