Compass Accelerates Psilocybin Launch Plans by Almost a Year

The largest news story this week came from Compass Pathways, as the psilocybin developer announced on Tuesday that it is bringing forward its launch planning by 9-12 months following progress in its second, larger Phase 3 trial (COMP006), which has now completed enrolment, and meetings with FDA. (See Compass Pathways Accelerates Psilocybin Launch Timeline by 9-12 Months.)

The news, which implies psilocybin could be FDA-approved as early as very late 2026 or early 2027, was broadly welcomed by investors and operators in the field. Shares in Compass rose sharply on Tuesday, when the news was announced, but have since sunk substantially, as have other public psychedelic companies this week.

Aside from our Tuesday morning coverage, which included an interview with Compass CEO Kabir Nath, we also tuned into the company’s conference call. Below are some notes from the Q&A section…

A Morgan Stanley analyst asked the company whether the agency has suggested that either TRD or PTSD might be a higher area of unmet need, in its view. Compass CEO Kabir Nath said that he does not believe that, at the agency level, there is any distinction between the two disorders, with both being viewed as “areas in desperate need for new options for patients.”

Later, an Evercore analyst asked whether unblinding 9-week data from COMP006 (the second, larger Phase 3 trial) might risk the integrity of the study, and whether presenting it earlier than planned could threaten the company’s ability to make commercial claims around the durability of the two-dose regimen.

Nath emphasised that it was the company’s choice, not the agency’s insistence, that led it to formerly plan not to disclose the 9-week Part A data before the 26-week Part B data. The CEO said that was in light of “a lot of the confusion and commentary around Lykos at the time”. Now that things are clearer...