FDA grants priority voucher to Compass Pathways' COMP360 treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 24 2026
0mins
Compass Pathways PLC shares surged 9.02% as the stock reached a 52-week high. The catalyst for this movement was the FDA granting a Commissioner’s National Priority Voucher to Compass Pathways' synthetic psilocybin treatment, COMP360, which enhances regulatory access and speeds up the review process for treatment-resistant depression. This development significantly boosts the market competitiveness of COMP360, with Jefferies estimating a 75%-85% chance of FDA approval in FY26, further fueling investor enthusiasm.
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Analyst Views on CMPS
Wall Street analysts forecast CMPS stock price to rise
7 Analyst Rating
6 Buy
1 Hold
0 Sell
Strong Buy
Current: 11.920
Low
8.00
Averages
18.43
High
40.00
Current: 11.920
Low
8.00
Averages
18.43
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.
Trump Pushes Psychedelic Research for Mental Illness Treatment
- Policy Shift: President Trump signed an executive order to accelerate research into psychedelic drugs, particularly for PTSD treatment, marking a significant shift in government stance that could open new market opportunities for related companies.
- Clinical Trial Results: Funded by the Multidisciplinary Association for Psychedelic Studies, approximately 71% of severe PTSD patients no longer met diagnostic criteria after MDMA-assisted therapy, demonstrating the potential of psychedelics in mental health treatment and possibly expediting FDA review processes.
- Market Reaction: Following the executive order, shares of psychedelic drug developers surged, reflecting investor optimism about the legitimization of an industry previously viewed as fringe, which may lead to increased capital inflow into the sector.
- Safety Concerns: Despite the therapeutic potential of psychedelics, researchers caution that different drugs carry varying safety profiles and risks, particularly ibogaine's cardiovascular risks, underscoring the need for more scientific research to ensure the efficacy and safety of these therapies.
See More
Compass Pathways Appoints New Board Member
- New Board Appointment: Compass Pathways plc elected Kathleen Tregoning to its Board of Directors at the annual general meeting, where she will serve on the Compensation and Leadership Development Committee and the Nominating and Corporate Governance Committee, bringing extensive biopharmaceutical industry experience.
- Successful Clinical Trials: The completion of two successful Phase 3 trials for COMP360 meeting primary endpoints indicates a transformative potential in treating treatment-resistant depression, bolstering the company's confidence in securing FDA approval.
- Strategic Development Insight: Tregoning's successful tenure at Cerevel Therapeutics, particularly during its acquisition by AbbVie, showcases her capability in driving growth and market access, which will be crucial for Compass's future trajectory.
- Innovative Treatment Outlook: With COMP360 designated as a Breakthrough Therapy, it is poised to offer new treatment options for patients with treatment-resistant depression, and Tregoning emphasized that patient education and access will be as critical as the scientific advancements during the regulatory review and commercialization phases.
See More
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- Conference Participation: Compass Pathways plc will attend the Jefferies Global Healthcare Conference on June 3, 2026, participating in a fireside chat at 12:45 PM ET, showcasing its innovations in mental health.
- Live Webcast: The event will feature a live audio webcast accessible from the 'Events' page in the Investors section of the Compass website, ensuring real-time updates for investors on the company's latest developments.
- Replay Availability: Following the event, a replay of the webcast will be available for 30 days, enhancing investor engagement and understanding of the company's progress.
- Innovative Treatment: Compass Pathways is advancing mental health innovation through its COMP360 synthetic psilocybin treatment, which has received Breakthrough Therapy designation from the FDA, indicating its potential in treating treatment-resistant depression.
See More
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- FDA Leadership Change: Michael Davis has been appointed as the acting head of the FDA's Center for Drug Evaluation and Research, previously serving as chief medical officer at Usona Institute, where he advanced psychedelic therapies, indicating a strong FDA focus on the psychedelic sector.
- COMP360 Receives Priority Voucher: Compass Pathways' synthetic psilocybin treatment, COMP360, has been granted a Commissioner’s National Priority Voucher by the FDA, which provides enhanced regulatory access and a significantly faster review timeline for treatment-resistant depression, greatly enhancing its market competitiveness.
- Stock Price Surge: Shares of Compass Pathways soared 16% in pre-market trading on Monday, and if these levels hold after the opening bell, the stock would reach its highest point in over two years, reflecting a resurgence of investor enthusiasm for psychedelic therapies.
- Investor Sentiment Optimistic: Retail sentiment on Stocktwits remains bullish for CMPS, with Jefferies forecasting a 75%-85% chance of FDA approval for COMP360 in FY26, further driving market interest and investment in the stock.
See More
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- Investor Capital Influx: Trump's executive order has sparked interest among investors in psychedelic drug development companies, with Enveric Biosciences raising $5 million following the announcement, indicating heightened market attention despite researchers cautioning that new treatments are still far from realization.
- Improved FDA-DEA Coordination: Nine executives and investors noted that the order could shorten administrative timelines and enhance coordination between the FDA and DEA, potentially saving clinical-stage companies tens of millions in costs and improving overall research efficiency.
- Reduced Regulatory Uncertainty: Sa'ad Shah, co-founder of Noetic Fund, highlighted that the executive order may attract institutional investors like sovereign wealth funds and public pension plans into the psychedelic sector, alleviating previous regulatory uncertainties and signaling credible government backing for the industry.
- Accelerated Development Processes: Robert Barrow, CEO of Definium Therapeutics, stated that the implementation of the order will streamline regulatory processes, particularly allowing the DEA to begin scheduling controlled substances after FDA approval, which will facilitate faster market access for psychedelic drugs.
See More
Compass Pathways to Attend RBC Healthcare Conference
- Conference Participation: Compass Pathways plc will attend the RBC Capital Markets Global Healthcare Conference on May 19-20, 2026, participating in a fireside chat on May 19 at 10:00 am ET, showcasing its innovations in mental health.
- Live Webcast: The event will feature a live audio webcast accessible from the 'Events' page in the Investors section of the Compass website, ensuring investors can stay updated in real-time, enhancing transparency and investor confidence.
- Therapeutic Innovation: Compass Pathways is pioneering a new paradigm in mental health treatment through its investigational COMP360 synthetic psilocybin therapy, which has received Breakthrough Therapy designation from the FDA, indicating its potential in treating treatment-resistant depression.
- Global Presence: Headquartered in London, UK, with an office in New York, the company demonstrates a global strategy aimed at accelerating patient access to evidence-based mental health innovations, addressing the needs of patients not helped by existing treatments.
See More
Trump Pushes Psychedelic Research for Mental Illness Treatment
- Policy Shift: President Trump signed an executive order to accelerate research into psychedelic drugs, particularly for PTSD treatment, marking a significant shift in government stance that could open new market opportunities for related companies.
- Clinical Trial Results: Funded by the Multidisciplinary Association for Psychedelic Studies, approximately 71% of severe PTSD patients no longer met diagnostic criteria after MDMA-assisted therapy, demonstrating the potential of psychedelics in mental health treatment and possibly expediting FDA review processes.
- Market Reaction: Following the executive order, shares of psychedelic drug developers surged, reflecting investor optimism about the legitimization of an industry previously viewed as fringe, which may lead to increased capital inflow into the sector.
- Safety Concerns: Despite the therapeutic potential of psychedelics, researchers caution that different drugs carry varying safety profiles and risks, particularly ibogaine's cardiovascular risks, underscoring the need for more scientific research to ensure the efficacy and safety of these therapies.
See More
Compass Pathways Appoints New Board Member
- New Board Appointment: Compass Pathways plc elected Kathleen Tregoning to its Board of Directors at the annual general meeting, where she will serve on the Compensation and Leadership Development Committee and the Nominating and Corporate Governance Committee, bringing extensive biopharmaceutical industry experience.
- Successful Clinical Trials: The completion of two successful Phase 3 trials for COMP360 meeting primary endpoints indicates a transformative potential in treating treatment-resistant depression, bolstering the company's confidence in securing FDA approval.
- Strategic Development Insight: Tregoning's successful tenure at Cerevel Therapeutics, particularly during its acquisition by AbbVie, showcases her capability in driving growth and market access, which will be crucial for Compass's future trajectory.
- Innovative Treatment Outlook: With COMP360 designated as a Breakthrough Therapy, it is poised to offer new treatment options for patients with treatment-resistant depression, and Tregoning emphasized that patient education and access will be as critical as the scientific advancements during the regulatory review and commercialization phases.
See More
Compass Pathways to Attend Jefferies Global Healthcare Conference
- Conference Participation: Compass Pathways plc will attend the Jefferies Global Healthcare Conference on June 3, 2026, participating in a fireside chat at 12:45 PM ET, showcasing its innovations in mental health.
- Live Webcast: The event will feature a live audio webcast accessible from the 'Events' page in the Investors section of the Compass website, ensuring real-time updates for investors on the company's latest developments.
- Replay Availability: Following the event, a replay of the webcast will be available for 30 days, enhancing investor engagement and understanding of the company's progress.
- Innovative Treatment: Compass Pathways is advancing mental health innovation through its COMP360 synthetic psilocybin treatment, which has received Breakthrough Therapy designation from the FDA, indicating its potential in treating treatment-resistant depression.
See More
FDA Leadership Change Boosts Psychedelic Drug Prospects
- FDA Leadership Change: Michael Davis has been appointed as the acting head of the FDA's Center for Drug Evaluation and Research, previously serving as chief medical officer at Usona Institute, where he advanced psychedelic therapies, indicating a strong FDA focus on the psychedelic sector.
- COMP360 Receives Priority Voucher: Compass Pathways' synthetic psilocybin treatment, COMP360, has been granted a Commissioner’s National Priority Voucher by the FDA, which provides enhanced regulatory access and a significantly faster review timeline for treatment-resistant depression, greatly enhancing its market competitiveness.
- Stock Price Surge: Shares of Compass Pathways soared 16% in pre-market trading on Monday, and if these levels hold after the opening bell, the stock would reach its highest point in over two years, reflecting a resurgence of investor enthusiasm for psychedelic therapies.
- Investor Sentiment Optimistic: Retail sentiment on Stocktwits remains bullish for CMPS, with Jefferies forecasting a 75%-85% chance of FDA approval for COMP360 in FY26, further driving market interest and investment in the stock.
See More
Trump's Executive Order Accelerates Psychedelic Drug Development
- Investor Capital Influx: Trump's executive order has sparked interest among investors in psychedelic drug development companies, with Enveric Biosciences raising $5 million following the announcement, indicating heightened market attention despite researchers cautioning that new treatments are still far from realization.
- Improved FDA-DEA Coordination: Nine executives and investors noted that the order could shorten administrative timelines and enhance coordination between the FDA and DEA, potentially saving clinical-stage companies tens of millions in costs and improving overall research efficiency.
- Reduced Regulatory Uncertainty: Sa'ad Shah, co-founder of Noetic Fund, highlighted that the executive order may attract institutional investors like sovereign wealth funds and public pension plans into the psychedelic sector, alleviating previous regulatory uncertainties and signaling credible government backing for the industry.
- Accelerated Development Processes: Robert Barrow, CEO of Definium Therapeutics, stated that the implementation of the order will streamline regulatory processes, particularly allowing the DEA to begin scheduling controlled substances after FDA approval, which will facilitate faster market access for psychedelic drugs.
See More
Compass Pathways to Attend RBC Healthcare Conference
- Conference Participation: Compass Pathways plc will attend the RBC Capital Markets Global Healthcare Conference on May 19-20, 2026, participating in a fireside chat on May 19 at 10:00 am ET, showcasing its innovations in mental health.
- Live Webcast: The event will feature a live audio webcast accessible from the 'Events' page in the Investors section of the Compass website, ensuring investors can stay updated in real-time, enhancing transparency and investor confidence.
- Therapeutic Innovation: Compass Pathways is pioneering a new paradigm in mental health treatment through its investigational COMP360 synthetic psilocybin therapy, which has received Breakthrough Therapy designation from the FDA, indicating its potential in treating treatment-resistant depression.
- Global Presence: Headquartered in London, UK, with an office in New York, the company demonstrates a global strategy aimed at accelerating patient access to evidence-based mental health innovations, addressing the needs of patients not helped by existing treatments.
See More
