Teleo Agents 6d4ad3213d vida: extract claims from 2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360

- Source: inbox/queue/2026-04-24-compass-pathways-fda-rolling-nda-priority-voucher-comp360.md
- Domain: health
- Claims: 0, Entities: 1
- Enrichments: 2
- Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5)

Pentagon-Agent: Vida <PIPELINE>

2026-05-11 04:29:19 +00:00

1.3 KiB

Raw Blame History

COMP006 Trial

Type: Phase 3 randomized controlled trial
Sponsor: Compass Pathways
Intervention: COMP360 (synthetic psilocybin)
Indication: Treatment-resistant depression (TRD)
Status: Completed (results announced February 2026)

Design

N = 568 participants
Arms: 25mg vs 10mg vs 1mg (placebo-like control)
Dosing: 2 doses administered 3 weeks apart
Primary endpoint: MADRS change from baseline

Results

Primary endpoint met: MADRS change -3.8 points vs control (p<0.001)
Response rate: 39% vs 23% control at week 6
Onset: Rapid improvement from next day post-dose
Second dose benefit: 40%+ of non-remitters after first dose achieved remission after second dose
Durability: Part B 26-week durability data expected early Q3 2026

Significance

COMP006 is the second consecutive positive Phase 3 trial for COMP360, making it the first psychedelic compound to achieve two positive Phase 3 results. Combined with COMP005, this formed the basis for FDA rolling NDA review and Commissioner's National Priority Voucher (April 2026).

Timeline

2026-02 — Results announced
2026-04-24 — FDA granted rolling NDA review based on COMP005 + COMP006 data
2026-Q3 — Part B 26-week durability data expected (final dataset for NDA)

1.3 KiB Raw Blame History