Compass Pathways reported 52-week Part C results from its Phase 3 COMP005 study of COMP360, its proprietary synthetic formulation of psilocybin, in treatment-resistant depression. The results sent the company’s Nasdaq-listed shares up more than 11%, reaching $15.63, or 11.32%, at publication, according to Benzinga Pro data, despite a broader market selloff. The trial enrolled 258 participants across three stages. Part A compared a 25 mg dose with placebo through Week 6, Part B assessed a second dose through Week 26, and about 70% of participants continued into the open-label Part C period from Weeks 26 to 52. Participants initially assigned to 25 mg who received an additional open-label dose recorded an average 13-point reduction in MADRS scores from baseline at Week 52. About 90% of the original placebo group entered Part C and received a first 25 mg COMP360 dose, producing an average 10-point MADRS reduction by the end of the extension. Across Part C participants who received 25 mg, response rates were 40% to 45% and remission rates were about 30% during the six weeks after dosing. Safety remained consistent with earlier phases, with no new safety signals and a generally well-tolerated profile. Compass said its rolling New Drug Application submission and review are underway, expects to complete the filing in the fourth quarter of 2026 and is targeting a commercial launch in the first half of 2027, subject to FDA approval and the rescheduling of psilocybin by the Drug Enforcement Administration. COMP360 has FDA Breakthrough Therapy designation, while Compass has also received a Commissioner’s National Priority Voucher. The company’s COMP006 study also met its primary endpoint. Compass is expanding physician education and monitoring regulatory developments as it prepares for commercialization.