The company highlighted ongoing FDA discussions around a potential rolling NDA submission for treatment-resistant depression, with additional Phase 3 data expected in 2026.
Compass Pathways (CMPS), on Wednesday, said the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug application for COMP360, a drug to treat post-traumatic stress disorder (PTSD). The latest update clears the way for a late-stage Phase 2b/3 clinical trial.
The study will evaluate the efficacy, safety, and tolerability of COMP360, with a blinded 12-week phase followed by a long-term open-label extension. The company said prior Phase 2 data showed the treatment was generally well tolerated and delivered rapid, durable symptom improvement.
Compass also highlighted ongoing FDA discussions around a potential rolling NDA submission for treatment-resistant depression, with additional Phase 3 data expected in 2026.
“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 believe COMP360 has the potential to transform the treatment landscape for PTSD and bring hope to those who need it most,” said Guy Goodwin, Chief Medical Officer at Compass Pathways.
CMPS stock was up over 5% in pre-market trading on Wednesday.
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