Compass Pathways says its COMP360 psilocybin NDA for treatment-resistant depression will be filed within two weeks

Compass Pathways says its final new drug application for COMP360 psilocybin in treatment-resistant depression will be filed within two weeks. CEO Kabir Nath said the company is preparing for a potential launch in the first half of 2027 and is also progressing its PTSD program. Management highlighted COMP360's treatment-resistant depression positioning, commercial preparations, payer strategy, field force, and potential use of a REMS framework. Compass also pointed to a National Priority Voucher that could shorten FDA review to one or two months and an executive order that could support rapid rescheduling. These measures also apply to Usona Institute, which is developing psilocybin for major depressive disorder, leaving the companies in a closely matched race toward possible approval. On a conference call, Compass declined to comment directly on Usona.