Compass Pathways Secures FDA Rolling Review

FDA granted Compass Pathways a rolling NDA review for its synthetic psilocybin drug COMP360 targeting treatment‑resistant depression.
COMP360 was also selected for the Commissioner’s National Priority Voucher, promising a 1‑2 month accelerated review after NDA filing.
Phase 3 trials with over 1,000 patients showed statistically significant results, with effects within one day and lasting up to six months.
CEO Kabir Nath highlighted the unmet need for 4 million U.S. patients and praised the validation of COMP360’s innovative science.