Compass Says NDA Will Be Filed Within Two Weeks, Declines to Comment on Usona

This morning, Compass Pathways shared its Q3 2026 results, which included an update on its COMP360 psilocybin for treatment-resistant depression (TRD) new drug application (NDA) submission. “Final NDA submission nearing completion”, the first bullet point in the release states, “and will be filed in the next two weeks.”

“With the imminent completion of our NDA submission and the potential for a quick approval,” its CEO, Kabir Nath, said in a statement, “we are executing with urgency and discipline to launch this much needed treatment in the first half of 2027.” He also emphasised that Compass is progressing its PTSD program.

The company points to the Commissioner’s National Priority Voucher (CNPV) it received in April (which it was apparently supposed to receive on its own last October before the Trump administration vetoed it), which it says “could shorten review times to 1-2 months”, as well as the April executive order, which it says could “support rapid rescheduling”. Both of these apply to Usona Institute, Compass’ nonprofit competitor that is pursuing major depressive disorder (MDD), too.

It is indeed neck and neck, then, in terms of the potential approval timeline for Compass and Usona, both of which are targeting a label that features a depressive disorder.

On an associated conference call, management struck a confident tone, leaning on COMP360’s TRD positioning and Compass’ commercial build-out, while declining to address its nonprofit competitor directly.

Here, we share notes from the release and the call...