Stifel on Compass Pathways: 'remains on-track to complete the rolling NDA submission for COMP360 in 4Q'

Stifel analyst Paul Matteis reiterated a Buy rating and a $21.00 price target on Compass Pathways (NASDAQ: CMPS), according to a statement from the firm.

Matteis noted that Compass Pathways remains on track to complete a rolling New Drug Application submission for its COMP360 treatment for treatment-resistant depression in the fourth quarter of 2026, with a commercial launch guided for the first half of 2027, pending DEA rescheduling at both the federal and state level.

COMP360 received a Collaborative NDA/BLA Program Voucher from the FDA in April, one of three issued to psychedelic programs, which the analyst said could accelerate regulatory review timelines to as short as one to two months. Management described its dialogue with the FDA as "very collaborative and constructive."

The analyst noted that FDA draft guidance issued recently included a stated preference for 12 months of blinded durability data, though this is not a requirement. Compass Pathways has six months of blinded data across both of its Phase 3 studies.

Matteis said management expects the REMS requirements for COMP360 to resemble those of Spravato, including a certified prescriber and two healthcare professionals on site. The company is targeting approximately 8,000 interventional psychiatry centers in the U.S. for its commercial launch.

Compass Pathways shares closed at $13.38 prior to the analyst note.

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