Compass Pathways plc announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug application for COMP360, a synthetic psilocybin formulation, for the treatment of post‑traumatic stress disorder (PTSD). The acceptance clears the company to begin a Phase 2b/3 trial (COMP202) that will enroll several hundred patients and evaluate the drug’s efficacy and safety over a 12‑week period.
The decision marks a strategic expansion of Compass Pathways’ pipeline beyond its flagship treatment‑resistant depression (TRD) program. COMP360 already holds Breakthrough Therapy designation for TRD, and the new PTSD trial will allow the company to address a broader unmet need that affects roughly 13 million adults in the United States.
COMP202 will recruit approximately 400 participants across multiple sites in the U.S. and Canada, with the primary endpoint set at a ≥50 % reduction in the Clinician‑Administered PTSD Scale (CAPS‑5) score at week 12. The trial is expected to begin enrollment in the second quarter of 2026 and to deliver pivotal data by the end of 2027.
While the PTSD program moves forward, Compass Pathways is simultaneously preparing for a commercial launch of COMP360 for TRD. Data from the Phase 3 studies COMP006 and COMP005 are slated for release in early 2026, and the company has indicated that it aims to be launch‑ready by year‑end pending regulatory approval.
Financially, Compass Pathways has recently amended its term‑loan facility with Hercules Capital, increasing the maximum borrowing capacity to $150 million. The extension provides a cash runway that extends into 2027, giving the company additional flexibility to fund the new trial and ongoing commercialization activities.
Chief Medical Officer Dr. Guy Goodwin emphasized the unmet need in PTSD, noting that the drug could transform the treatment landscape for a population that currently has limited options. Chief Executive Officer Kabir Nath highlighted the company’s momentum, stating that the FDA acceptance “demonstrates the strength of our science and the confidence regulators have in our approach.”
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.