Compass Pathways Stock Rises as COMP360 Data Show Lasting Depression Relief
Compass Pathways (NASDAQ:CMPS) saw its stock climb by 4% on Wednesday, following new data from its Phase III study of COMP360. This investigational oral psilocybin treatment is being developed for treatment-resistant depression (TRD).
The data comes from the open-label Part C portion of Study '005 and shows that patients across both arms experienced substantial and sustained improvement in depression symptoms by Week 52. The response and remission rates were strong, with a consistent safety profile.
Analysts at Jefferies are confident that COMP360 will receive FDA approval for TRD, citing the Breakthrough Therapy Designation and priority review voucher Compass has secured. This could shorten the review period to one to two months, compared to 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 estimates that COMP360's dosing profile will be more favorable than Johnson & Johnson (NYSE:JNJ)'s Spravato, requiring only 12 to 24 total clinic hours annually versus up to 100-plus hours for patients on Spravato.
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.