Compass Pathways (NASDAQ: CMPS) Surges 10.92% After FDA Accepts COMP360 IND Application for PTSD

Compass Pathways (NASDAQ: CMPS) surged 10.922% in pre-market trading on January 8, 2026, following the U.S. Food and Drug Administration’s acceptance of its Investigational New Drug (IND) application for COMP360, a synthetic psilocybin therapy targeting post-traumatic stress disorder (PTSD). This regulatory milestone enables the initiation of a late-stage Phase 2b/3 clinical trial, marking a critical step in the company’s development pipeline.

The IND acceptance follows positive Phase 2 open-label data showing COMP360’s safety and durable symptom reduction in PTSD patients. The upcoming trial will evaluate the treatment’s efficacy, safety, and long-term tolerability across two phases, with results from the open-label extension expected to inform future regulatory submissions. Compass also highlighted its ongoing commercial preparations for COMP360 in treatment-resistant depression (TRD), including a recent Type B meeting with the FDA to discuss potential accelerated approval pathways.

Management hosted a webinar featuring key opinion leaders and industry experts to discuss PTSD and TRD treatment landscapes, commercial strategies, and infrastructure readiness. The session underscored Compass’s focus on addressing unmet needs in mental health, with COMP360’s Breakthrough Therapy designation and UK ILAP status reinforcing its potential as a transformative therapy. The company’s expanded $150 million term loan facility further supports its near-term operational and clinical objectives.

With regulatory and commercial momentum building, Compass Pathways is positioning itself to capture a significant share of the mental health treatment market. The Phase 2b/3 trial is expected to generate robust data on COMP360’s potential to deliver durable clinical outcomes, which could lead to a broader patient access strategy and partnerships with key healthcare providers. Compass is also exploring international expansion opportunities, particularly in Europe and Canada, where psychedelic-assisted therapy is gaining regulatory traction.

Looking ahead, Compass plans to report interim Phase 2b data in the second quarter of 2026, with full trial results expected by the end of the year. These outcomes will be critical in shaping the next phase of COMP360’s development, including potential FDA discussions on regulatory pathways and commercial timelines. Investors are closely watching these developments, as they could influence Compass’s stock trajectory and broader market perception of the psychedelic therapy space.