Compass Pathways Accelerates Psilocybin Launch Timeline by 9-12 Months

This morning, Compass Pathways announced that it is preparing to launch its psilocybin therapy (COMP360) for treatment-resistant depression (TRD) at least nine months earlier than previously planned, following a “positive” September meeting with FDA.

“We’re excited, we think this is great news”, Compass CEO Kabir Nath told Psychedelic Alpha this morning. “This is a potential acceleration by certainly nine months or so”, he continued, with a related press release stating that the company is accelerating its commercial launch plans by 9-12 months.

Part of that acceleration, Nath told us, is down to the willingness of the FDA to accept a rolling submission of Compass’ new drug application (NDA), as opposed to waiting to accept the full package following the completion of all sections. Aside from the agency’s apparent interest in reviewing the package, Compass is also set to read out data from its Phase 3 program ahead of schedule, which is also expected to contribute to that earlier-than-expected potential launch.

Here, we delve much deeper into this breaking news, which we discussed with the Compass CEO, Nath, earlier this morning…