Compass Pathways Brings Psilocybin Therapy for Mental Health Closer to Market

Too long to read? Go for the highlights below.

• Compass Pathways accelerates its planned commercial launch of COMP360 for treatment-resistant depression by up to a year after favourable engagement with the FDA.

• Phase 3 data remain the decisive hurdle, with key 9-week and 26-week readouts expected in early 2026.

• Despite rising losses linked to warrant liability adjustments, the company reports a strengthened cash position sufficient to operate into 2027.

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Regulatory momentum and strategic recalibration

A shift in tone at the US Department of Health and Human Services has coincided with a decisive strategic turn for Compass Pathways. Following a period of mounting political interest in psychedelic therapies, the company now plans to accelerate commercial readiness for its investigational psilocybin treatment, COMP360, by nine to twelve months.

The decision follows a positive meeting with the US Food and Drug Administration (FDA), in which regulators indicated openness to a rolling review of the firm’s eventual New Drug Application for treatment-resistant depression (TRD).

Compass has attributed this change in momentum to two converging factors: strong clinical progress and heightened regulatory attention to psychedelic-assisted therapies. Its chief executive has described how lessons from the earlier Phase 3 study, COMP005, helped streamline operations in the second trial, COMP006, improving recruitment and provider engagement. But the company also recognises that the broader regulatory environment has become more receptive, with senior US health officials publicly signalling support for expanding access to psychedelic-based treatments.

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Phase 3 data nearing critical milestones

The company’s advancement rests on a multistage clinical programme. The first Phase 3 study, COMP005, achieved its six-week primary endpoint earlier this year, demonstrating a statistically significant reduction in depression severity from a single administration of COMP360 with no unexpected safety concerns.

COMP006, the second and larger Phase 3 study with 585 participants, has now completed enrolment. Compass plans to disclose the 9-week data from COMP006 alongside 26-week findings from COMP005 in the first quarter of 2026. The long-term data from COMP006 are scheduled for release in early third quarter 2026. These readouts remain essential; the company’s accelerated launch timeline ultimately depends on positive, durable outcomes across both trials.

Beyond depression, Compass is preparing late-stage development plans for post-traumatic stress disorder. A 12-week Phase 2 open-label study in PTSD, involving 22 participants and completed in 2024, reported tolerability and sustained symptom improvement. These findings were published in the September 2025 'Journal of Psychopharmacology', offering early signals of potential broader therapeutic applicability.

Financial strain amid strategic expansion

The firm’s ambitions sit against a backdrop of widening losses. For the third quarter of 2025, Compass reported a net loss of $137.7 million, compared with $38.5 million in the same period the previous year. Much of this increase is driven not by operational activity but by a $101.3 million non-cash fair-value adjustment linked to warrant liabilities, a figure sensitive to share-price movements and market conditions.

Research and development expenditure for the quarter reached $27.3 million, down from $32.9 million in 2024, largely due to the wind-down of earlier discovery programmes. General and administrative costs also declined to $13.2 million, reflecting reduced staffing levels and lower insurance and banking fees following restructuring.

Despite the larger reported losses, Compass strengthened its liquidity position. Cash and cash equivalents rose to $185.9 million as of 30 September 2025, up from $165.1 million at the end of 2024. The company maintains that this capital is sufficient to fund operations into 2027, with projected net cash use for the full year estimated between $120 million and $145 million.

A cautious but material lead

Compass’s acceleration signals a notable lead in the race toward the first FDA-approved psychedelic therapy. Yet the firm itself emphasises that progress hinges on rigorous data rather than administrative enthusiasm. The coming year will test whether the optimism generated by its early Phase 3 results can be sustained across larger, more complex datasets.

Regulatory interest may be rising, but approval remains contingent on demonstrable safety, efficacy and the company’s ability to transition from clinical development to commercial execution which is a task made more challenging by the unconventional nature of psychedelic-assisted therapy.

If successful, the pathway carved by COMP360 may reshape mental-health treatment models. For now, Compass finds itself moving faster than expected, propelled by a combination of political attention, regulatory engagement and promising early evidence.