COMPASS Pathways (CMPS) Morgan Stanley 24th Annual Global Healthcare Conference summary

Regulatory and development milestones

• NDA filing and rolling review for a novel psychedelic therapy in treatment-resistant depression (TRD) is underway, with FDA engagement and a launch targeted for the first half of 2027.

• The submission is expected to complete in Q4, with a Commissioner's National Priority Voucher expediting review and a potential six-month PDUFA timeline.

• The FDA has maintained high engagement, with draft label and REMS framework already under review, and inspections ongoing.

• Federal and state rescheduling is required post-approval, with 93% of the US population in states expected to reschedule within 30 days.

• Breakthrough therapy designation has been held since 2018, supporting ongoing regulatory interactions.

Clinical trial insights and efficacy

• Phase III trials (COMP005 and COMP006) demonstrated rapid and durable efficacy, with significant MADRS reductions and response within 24 hours.

• Durability of effect extends to 26 weeks with two doses, and up to a year with a third dose, with most adverse events being mild and transient.

• Remission and response rates improved over time, with open-label data showing remission in the 30% range and response rates in the 40% range.

• The patient population is highly refractory, with average depressive episodes lasting three to four years and minimal existing treatment options.

• Dosing is expected to be two initial doses three weeks apart, with redosing at physician discretion, typically two to four times annually.

Market opportunity and competitive landscape

• TRD affects 4 million patients in the US, with less than 5% currently receiving indicated treatments; only one other approved product exists.

• Existing SPRAVATO infrastructure (8,500 sites) is ready to support the new therapy, with no additional requirements for centers.

• Payers are highly engaged and receptive due to the unmet need and the therapy's rapid, durable effect, supporting strong pricing potential.

• The therapy's lower dosing frequency reduces patient and caregiver burden compared to SPRAVATO, which requires up to 52 visits per year.

• Growing interest in psychedelic therapies is expanding the provider base, with multiple products expected to enter the market.