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Compass Pathways Completes COMP360 Psilocybin New Drug Application to U.S. FDA for Treatment-Resistant Depression

Monday, November 9, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: Compass Pathways has submitted a New Drug Application to the U.S. FDA for COMP360 psilocybin, aimed at treating treatment-resistant depression. This investigational drug represents a proprietary formulation of psilocybin. The company emphasizes the urgent need for new mental health treatment options.

Market Sentiment Analysis

POSITIVE FACTORS

  • COMP360 psilocybin targets treatment-resistant depression.
  • Submission of NDA to the U.S. FDA completed.
  • Potential for new treatment options in mental health.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+2%
120-day peak, hindsight
Typical move
6.5%
average across 4 past catalysts
Cash runway
~26 mo
Low dilution risk
Lead asset
COMP360
Phase 3 · Treatment Resistant Depression

Full Press Release Details

LONDON & JERSEY CITY, N.J.--(BUSINESS WIRE)---- $CMPS #Biotech--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, today announced the Company completed its submission of a New Drug Application (NDA) to the U.S. FDA for COMP360 psilocybin, its investigational synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). "People living with treatment-resistant depression have gone too long ex

Frequently Asked Questions

What is COMP360 psilocybin?

COMP360 psilocybin is an investigational synthetic formulation aimed at treating depression.

What did Compass Pathways submit to the FDA?

Compass Pathways submitted a New Drug Application for COMP360 psilocybin.

What condition does COMP360 target?

COMP360 is designed for treatment-resistant depression.

Why is COMP360 important?

It offers potential new treatment options for mental health care.

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Tags: CMPS Compass Pathways FDA NDA treatment-resistant depression psilocybin
Last updated: Nov 9, 2026

Biotech snapshot

Cash runway
$444M liquidity · $17M/mo burn
~26 mo
Low dilution risk
Lead asset
COMP360Phase 3
Treatment Resistant Depression →

Catalyst track record

+2%
best trade around CMPS's most recent catalyst

Peak hindsight return over a 120-day window, across 4 tracked FDA/PDUFA catalysts for CMPS.

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