Compass Pathways plc (CMPS) — Compass Pathways said the FDA accepted its Investigational New Drug application for COMP360 psilocybin in PTSD, enabling initiation of a Phase 2b/3 study (COMP202) in patients with PTSD.
Alongside the acceptance, management hosted a webinar with clinical and industry experts on its PTSD plans and commercial preparations for treatment-resistant depression, expanding the psilocybin franchise into a second major psychiatric indication as the company moves toward a rolling NDA submission in TRD.
Source: businesswire.com
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