51% — When will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression
Kalshi 51% · 5 contracts · $0 volume · medium confidence
Updated 2026-09-21 23:35:05 UTC

Why this matters:
The 59% probability reflects market expectations that the FDA will approve Compass Pathways' COMP360 psilocybin therapy for treatment-resistant depression by July 2027. Contract pricing suggests near-term approval (before January 2027) is considered unlikely at 16%, while approval within 12 months is priced at 70%, indicating most probability mass falls in the second half of 2026 or early 2027. The level reflects both the therapy's positive Phase 3 trial data and typical FDA review timelines for novel psychiatric treatments. Key uncertainties include whether Compass meets the FDA's manufacturing and safety requirements, the strength of the clinical evidence package, and whether the agency flags additional questions during standard or priority review. The next material event would be an FDA decision or official communication about the application status, which typically occurs within 6-10 months of submission.

Key factors:
- COMP360 demonstrated statistical significance in Phase 3 trials for treatment-resistant depression with measurable reduction in depressive symptoms versus placebo
- FDA priority review or standard review designation affects timeline, with priority review potentially compressing the decision window by several months
- Manufacturing and quality requirements for controlled psilocybin products may trigger FDA requests for additional data or site inspections
- Market pricing shows 86% probability by end of 2028 but only 16% by January 2027, suggesting the most likely approval window is mid-to-late 2027
- Regulatory precedent with other psychedelic therapies and recent FDA guidance on psychiatric drug development will influence approval pathway

Contracts:
- Will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression before Jan 1, 2027?: Before Jan 1, 2027 — 30¢ Kalshi $0 (weight 20%)
- Will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression before Mar 1, 2027?: Before Mar 1, 2027 — 71¢ Kalshi $0 (weight 20%)
- When will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression?: Before July 2027 — 36¢ Kalshi $0 (weight 20%)
- When will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression?: Before October 2027 — 83¢ Kalshi $0 (weight 20%)
- When will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression?: Before 2028 — 35¢ Kalshi $0 (weight 20%)

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## Methodology

SimpleFunctions aggregates live YES-side prices from Kalshi and Polymarket contracts bound to this question. For binary topics the headline is the liquidity-weighted mid-price (weight = log(1 + 24h volume) × freshness, where freshness is 1.0 if updated <24h, 0.7 if <7d, 0.4 otherwise). For multi-outcome (winner-take-all) topics the headline is the current leader's price — disjoint outcomes are never arithmetically averaged. Snapshots refresh every 5 minutes during market hours.

## SF Signal

- SF Index, regime, and 30d Brier calibration are computed separately and surfaced at https://simplefunctions.dev/admin/calibration.
- No SimpleFunctions index / regime / calibration signal is bound to this topic yet — the headline above is market-derived only.

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*Last verified: 2026-09-21T23:20:51.266Z*

By SimpleFunctions — https://simplefunctions.dev/

Cite as: "51% per prediction markets (SimpleFunctions, September 2026)"
Canonical: https://simplefunctions.dev/answer/fdaapprovaldatecmps-360
Full data: https://simplefunctions.dev/api/public/query?q=When%20will%20the%20FDA%20approve%20COMP360%20Psilocybin%20for%20Treatment-Resistant%20Depression
Provider: SimpleFunctions — https://simplefunctions.dev