Oppenheimer says CNPV designation strengthens case for Compass Pathways’ COMP360

Oppenheimer views FDA granting a CNPV with agreement on New Drug Application rolling review as reinforcing the firm’s conviction considering the earlier launch timeline for COMP360 in treatment-resistant depression. Compass Pathways (CMPS) previously expected NDA submission in Q4 2026 following the Phase 3 COMP006 26-week readout in Q3, informing Oppenheimer’s prior expectation for launch in mid-2027. The firm now believes launch could occur by year-end 2026 assuming the NDA rolling submission still includes the durability data, while CNPV enables the shortened 1- to 2-month review timeline. Compass Pathways already planned for launch readiness by year-end 2026, and Oppenheimer anticipates management will execute a successful launch according to the updated timelines. The firm has an Outperform rating on the shares with a price target of $20.