Compass Pathways Receives FDA Approval for COMP360 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 07 2026
0mins
Compass Pathways announced that the U.S. FDA has accepted its Investigational New Drug application for COMP360, enabling the initiation of a late-stage clinical trial in patients with PTSD.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy CMPS?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on CMPS
Wall Street analysts forecast CMPS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CMPS is 17.67 USD with a low forecast of 8.00 USD and a high forecast of 40.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 6.710
Low
8.00
Averages
17.67
High
40.00
Current: 6.710
Low
8.00
Averages
17.67
High
40.00
About CMPS
Compass Pathways plc is a United Kingdom-based biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is engaged in treating mental health conditions focused on rapid and durable responses through the development of its investigational COMP360 psilocybin treatment. COMP360 is its psilocybin formulation that includes its pharmaceutical-grade polymorphic crystalline psilocybin, optimized for stability and purity. The Company’s initial focus is on treatment-resistant depression (TRD), comprising patients who are inadequately served by the current treatment paradigm. It commenced its Phase III program evaluating its COMP360 psilocybin treatment in TRD. In addition, the Company has ongoing Phase II trials in PTSD and anorexia nervosa. It also provides support to research institutions conducting investigator-initiated studies with COMP360 psilocybin in areas of serious unmet need.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Compass Receives FDA Approval for COMP360 PTSD Clinical Trial
- Clinical Trial Launch: The FDA's acceptance of the IND application for COMP360 enables Compass to initiate a Phase 2b/3 clinical trial for PTSD, which is expected to significantly advance the development of new therapies and meet the urgent market demand for effective treatments.
- Commercialization Readiness: Compass is preparing for the market launch of COMP360 for treatment-resistant depression (TRD) by the end of 2026, aiming to address the current gap in the market with only two FDA-approved medications available for approximately 4 million TRD patients.
- Strategic Collaboration Expansion: Compass has partnered with Radial, a national network of mental health treatment clinics, to enhance the integration of COMP360 into various healthcare settings, thereby increasing its market competitiveness and improving patient access to treatment.
- Increased Financial Flexibility: Compass amended its loan agreement with Hercules Capital to increase the loan size to $150 million, providing greater financial flexibility to support future clinical trials and commercialization efforts, ensuring the company maintains sufficient cash flow through 2027.
Continue Reading
Compass Pathways Partners with Radial Health to Advance COMP360 Treatment Models
- Strategic Collaboration Expansion: Compass Pathways has entered its seventh strategic collaboration with Radial Health to optimize scalable delivery models for the COMP360 psilocybin treatment, which could significantly enhance patient treatment options if FDA approved.
- National Network Development: Radial Health operates across five states in the U.S., aiming to build a national network of interventional psychiatry clinics, and through collaboration with Compass, will facilitate the integration of innovative treatment options to improve patient experiences.
- Innovative Treatment Potential: The COMP360 psilocybin treatment is viewed as a potential paradigm shift in mental health treatment, and both parties will explore its application within Radial's delivery model, which could provide more effective treatment options for patients if successful.
- Diverse Collaboration Model: Compass has established partnerships with various mental health organizations, gathering valuable insights on how the COMP360 treatment can be integrated into different healthcare settings, thereby enhancing its market acceptance.
Continue Reading