Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP‑360, reinforcing the company’s plan to seek regulatory approval. The company said the two pivotal trials met their primary endpoints at six weeks and that effect durability was observed through later timepoints, prompting preparations for a rolling NDA filing. The results come from two independent phase III programs described by Compass and covered in contemporaneous market reports; company statements indicate plans to advance a rolling submission to the US FDA later this year. COMP‑360 holds breakthrough therapy designation, which could accelerate review timelines if the agency agrees the data package supports a favorable risk‑benefit profile. Clinical readers should note that COMP‑360 is a single‑dose psychedelic administered with therapeutic support — approval would hinge on both drug efficacy and the controlled delivery model around supervised therapy sessions. The next steps include regulatory meetings, submission timing and further disclosure of detailed safety and efficacy datasets.