Compass Pathways (NASDAQ:CMPS) climbed 4% on Wednesday after new 52-week data from the company's Phase III study of COMP360, its investigational oral psilocybin treatment for treatment-resistant depression (TRD).
The data, from the open-label Part C portion of Study '005, showed sustained efficacy with an infrequent dosing paradigm of two to four times per year.
By Week 52, patients across both arms showed substantial and sustained improvement in depression symptoms, with strong response and remission rates, a consistent safety profile, and the large majority choosing to continue with 25mg dosing.
Analysts at Jefferies said they are confident the FDA will approve COMP360 for TRD, a market the firm estimates at more than four million patients in the US and over $1.5 billion in peak sales opportunity.
The analysts noted that Compass has secured a Breakthrough Therapy Designation and a priority review voucher, which could shrink the FDA's review period to one to two months, compared with eight months under standard priority review.
The company's rolling New Drug Application submission is on track to complete in the fourth quarter of 2026, supporting a planned launch in the first half of 2027.
Jefferies compared COMP360's dosing profile favorably to Johnson & Johnson (NYSE:JNJ)'s Spravato, an approved TRD therapy with a run rate of more than $2.3 billion, which can be dosed up to 56 times per year. The analysts estimated that COMP360's six-hour treatment sessions would require 12 to 24 total clinic hours annually, versus 50 to 100-plus hours for patients on Spravato's more frequent regimen.
Jefferies applied a peak sales estimate of $1.5 billion and a multiple of two to three times to arrive at a valuation range of $3 billion to $4.5 billion for Compass, up from the company's current market capitalization of more than $1.9 billion.
