Shares of Compass Pathways Plc (NASDAQ:CMPS) rose about 3% in premarket trading on Wednesday after the company said the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for COMP360, paving the way for a late-stage study in patients with post-traumatic stress disorder.
With the IND now in place, Compass will move ahead with a Phase 2b/3 clinical programme designed to assess the efficacy, safety and tolerability of COMP360 in PTSD. The trial will be run in two stages, beginning with a 12-week randomized, double-blind, controlled period, followed by a 40-week open-label extension.
Commenting on the milestone, Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways, said: “PTSD is one of the most challenging mental health conditions, with approximately 13 million adults in the U.S. living with persistent symptoms and limited treatment options. We are pleased to advance our clinical development – the unmet need is profound, and it demands bold innovation.”
Alongside its PTSD programme, Compass continues to advance preparations for the potential commercial launch of COMP360 in treatment-resistant depression (TRD). The company said it aims to be launch-ready by the end of the year, subject to regulatory approval. In September, Compass held a constructive Type B meeting with the FDA to discuss its New Drug Application strategy for COMP360 in TRD.
Looking ahead, Compass plans to release data from its second Phase 3 study, COMP006, including nine-week results, together with six-week and 26-week data from COMP005, in the second half of the first quarter of 2026. Additional 26-week data from COMP006 are expected in early Q3 2026.
Separately, the company said it has amended its term loan agreement with Hercules Capital, increasing the total facility to as much as $150 million and extending its cash runway into 2027.