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Compass Pathways’ psilocybin drug application heads to the FDA 

By Ella Ruder 1 min read

Biotechnology company Compass Pathways has completed its new drug application to the FDA for COMP360, an investigational synthetic psilocybin formulation for treatment-resistant depression, the company said Nov. 9. The application rests on two phase 3 trials and a phase 2b study. Each met its primary endpoint, and together they enrolled more than 1,000 patients with chronic treatment-resistant depression. Compass expects to launch COMP360 in the first half of 2027 if the FDA approves it. The FDA had already granted the drug rolling review and a Commissioner’s National Priority Voucher, which… Originally published in Becker’s Hospital Review. Read More

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