Scan: When will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression? — Before July 2027

date	predicted	market price	confidence
2026-09-06	76%	79%	62%
2026-08-29	72%	79%	66%
2026-08-22	70%	79%	62%

1. Planner Fable 5.1 · Fermi decomposition + tool plan

Tools chosen: kalshi_direct kalshi_related polymarket_related article_search claude_news earnings_data gdelt_news wikipedia code_execution

Sub-questions (Fermi decomposition)

When does Compass Pathways plan to complete its rolling NDA submission for COMP360, and has any portion been submitted yet?
Has FDA granted or is it likely to grant priority review, and what PDUFA date would result from the expected submission timing?
What were the COMP005 and COMP006 Phase 3 topline/durability results, and are there safety or functional-unblinding concerns that could trigger a CRL like Lykos's MDMA?
What is FDA's current stance on psychedelic therapeutics under current leadership (e.g., statements from Makary/Kennedy, Breakthrough designation status, advisory committee plans)?
What is the historical base rate and timeline for first-cycle approval of novel CNS drugs with Breakthrough Therapy designation, and how often do PDUFA dates slip?
Does Compass have sufficient cash runway and CMC/manufacturing readiness to avoid submission delays before mid-2027?

Planner reasoning

COMP360 approval before July 2027 hinges on Compass Pathways' NDA submission timing (they've signaled a rolling submission with COMP006 26-week data), whether FDA grants priority review (6-month vs 10-month clock), and FDA's evolving posture on psychedelics (Lykos MDMA CRL precedent, new leadership statements). The Kalshi price is the primary anchor; Compass stock (CMPS) and news on COMP005/COMP006 results and NDA timelines will refine it.

2. Research Parallel tool calls

tool	status	time	items	summary
kalshi_direct	OK	0.2s	1	## This Market's Kalshi Data Before July 2027 (KXFDAAPPROVALDATECMPS-360-27JUL01) - Current price (probability): 86.00% - 7-day price change: +7.00% - 30-day price change: +17.00% - Average daily volume: 54 contracts - Price range: 69.00% - 94.00% - Data points: 22 days
kalshi_related	OK	4.1s	0	0 related markets / summaries. series KXFDAAPPROVALDATECMPS: 0 markets (skipped 5 no-signal) \| keyword 'COMP360': no matches \| keyword 'psilocybin': no matches \| keyword 'Compass Pathways': no matches
polymarket_related	OK	4.0s	0	Scanned 100 active Polymarket markets, kept 0 matches. keyword 'psilocybin': 0 markets \| keyword 'COMP360': 0 markets \| keyword 'Compass Pathways': 0 markets \| keyword 'FDA approve psychedelic': 0 markets
article_search	OK	4.4s	22	Fetched 22 unique articles across 3 queries (lookback=120d). 'Compass Pathways COMP360 NDA submission rolling FDA': 10 articles \| 'COMP006 Phase 3 psilocybin treatment-resistant depression results': 10 articles \| 'FDA psychedelic approval Makary psilocybin priority review': 10 articles
claude_news	OK	20.9s	17	Here are the key findings on COMP360's path to FDA approval: NDA Submission Timeline - Compass Pathways is conducting a rolling NDA submission, with rolling NDA submission and initial review underway and final submission expected to be completed in Q4, with commercial launch-readiness on track
earnings_data	OK	4.1s	1	Fetched FMP data for 1 ticker(s).
gdelt_news	OK	138.5s	0	GDELT: 0 articles across 2 queries (lookback=60d). 'Compass Pathways COMP360 FDA': error GDELT rate-limited after retries (429) \| 'psilocybin FDA approval depression': error GDELT rate-limited after retries (429)
wikipedia	OK	4.1s	3	Fetched 3 Wikipedia entries (0 missing pages).
code_execution	OK	48.4s	0	## Key Findings PDUFA Date Calculations by Scenario (submission = quarter midpoint; Priority = submission+8mo incl. 60‑day filing; Standard = submission+12mo): \| NDA Submission \| Priority Review PDUFA \| Standard Review PDUFA \| Priority PDUFA even w/ +3mo extension \| \|---\|---\|---\|---\| \| Q4 2025

3. Evidence Brief Sonnet 5 · 7408 chars

# Current state Compass Pathways is mid-way through a rolling NDA submission for COMP360 (psilocybin) in treatment-resistant depression; the final tranche is targeted for completion in Q4 2026, and no PDUFA date has been set yet since the application is not yet complete (claude_news, merlintrader.com, Apr–Jul 2026 trackers). The drug holds Breakthrough Therapy designation and a Commissioner's National Priority Voucher (CNPV), which promise expedited review (goal: 1–2 months post-filing) but are administrative goals, not statutory guarantees. # Timeline of key events - **2026 (year, exact date unclear, pre-Apr)** — FDA grants rolling review and selects COMP360 for the CNPV pilot program, promising a 1–2 month post-filing review goal (confirmed per claude_news/allsci.com, though framed as "goal not binding"). - **2026-03** — At Stifel Healthcare Forum, Compass management guides to a PDUFA date "late 2026 into 2027" (reported, investing.com transcript). - **2026-05-31** — CNBC reports Trump administration pushing to fast-track psychedelic therapeutics; Compass CEO states company adheres to standard FDA data requirements (confirmed reporting). - **2026-07-07** — Compass announces six-month (26-week) durability data from second Phase 3 trial (COMP006 Part B), confirming rapid and durable antidepressant effect (confirmed, company press release/BusinessWire/SEC 8-K). - **2026-07-10** — Independent tracker (merlintrader.com) confirms parts of NDA already under FDA review; final submission still targeted Q4 2026 (reported). - **2026-07-19** — CNBC reports CEO Kabir Nath saying company will be "launch-ready" by end of 2026 with commercial infrastructure (250–300 person sales force) and expects product on market "first part of 2027"; confirms CNPV voucher granted via Trump executive order (reported/confirmed mix). - **Ongoing/unresolved** — No formal PDUFA date announced as of latest data (mid/late 2026); DEA rescheduling of psilocybin (Schedule I) still required post-FDA-approval before commercial launch (structural fact, claude_news). # Event Will the FDA approve COMP360 (psilocybin) for treatment-resistant depression before July 1, 2027? # Outcomes to forecast - Yes (approved before July 2027) - No (not approved before July 2027) # Kalshi market anchor **Current YES price: 86%** — up sharply from ~69% a month ago (+17% over 30 days, +7% over 7 days). Thin market (avg 54 contracts/day over 22 data points), so moves are somewhat volume-light but directionally consistent with bullish news flow (strong COMP006 durability data, CEO launch-readiness comments). No related Kalshi/Polymarket markets found for cross-referencing. # Sub-question answers 1. **Rolling NDA timeline/submission status** — Rolling submission is underway; portions already under FDA review; final submission targeted for completion in Q4 2026 (merlintrader.com, claude_news, confirmed by multiple July 2026 sources). 2. **Priority review / PDUFA date** — FDA granted rolling review and selected COMP360 for the CNPV pilot (implying expedited 1-2 month review post-filing), but this is a stated goal, not binding; no formal PDUFA date has been set as of mid-2026 (claude_news). 3. **COMP005/COMP006 results & CRL risk** — COMP006 met primary endpoint at Week 6 with high statistical/clinical significance; 26-week durability confirmed in both trials (39% response at 25mg maintained through wk26 in COMP005; COMP006 Part B durability through wk26). Serious adverse events low and similar across arms (5.7–6.3%). No specific unblinding/functional-unblinding controversy reported in this research (unlike Lykos/MDMA), suggesting lower CRL risk than the MDMA precedent, though not explicitly addressed as ruled out. 4. **FDA stance under current leadership** — Trump executive order directs DEA to expedite psychedelic rescheduling review upon Phase 3 completion; administration actively encouraging fast-tracking, and CNPV voucher granted to Compass as one of three biotechs (CNBC, confirmed). One outside expert quoted worries political momentum could outpace science, but no adverse FDA leadership statement found. 5. **Historical base rate for BTD novel CNS drugs** — Not directly answered by news sources; code_execution model assumes ~60–70% first-cycle approval rate for novel CNS/Breakthrough NDAs as a working estimate (analytical assumption, not sourced empirically). 6. **Cash runway / CMC readiness** — Not directly detailed in research; CEO states company will be "launch-ready" (commercial prep, sales force) by end of 2026, implying no near-term funding/manufacturing barrier reported (CNBC, reported). # Key facts (high-confidence, factual) 1. [claude_news/company IR] COMP006 Part A met primary endpoint at Week 6; Part B confirmed 26-week durability. 2. [claude_news] Serious adverse events ~6% across arms, most AEs transient dosing-day events. 3. [CNBC 2026-07-19] Compass granted CNPV under Trump executive order; CEO targets commercial launch "first part of 2027." 4. [merlintrader.com] Rolling NDA partially under FDA review; final piece targeted Q4 2026. 5. [Wikipedia] COMP360 holds FDA Breakthrough Therapy designation. 6. [Wikipedia] Psilocybin remains Schedule I; DEA rescheduling required post-approval before launch. # Cross-market signals - Kalshi related: none found (0 related markets/series). - Polymarket: no matching markets found. - Sportsbook implied: not applicable (biotech/regulatory event). # Analyst opinions and speculation - Evercore (post-COMP006 data, reported): approval likely H1 2027 or sooner; upgraded stock. - Stifel Forum (Mar 2026, company guidance): PDUFA "late 2026 into 2027." - Independent tracker (psychedelicbeacon.com): earliest realistic approval Q4 2026–Q1 2027, contingent on Q4 2026 NDA completion and CNPV 1-2 month goal holding. - code_execution model: blended probability of approval before July 2027 ≈ 55–64% based on submission-timing scenarios × ~60–70% first-cycle CNS approval base rate — notably lower than Kalshi's 86%. # Directional lean per outcome - **Yes**: Strong durability/safety data, CNPV/Breakthrough expedited pathway, administration actively pushing psychedelic approvals, company guidance points to H1 2027 launch, Kalshi trending up (69%→86%). - **No**: No PDUFA date set yet; NDA completion (Q4 2026) not yet confirmed; CNPV timeline is a "goal not binding"; CRL precedent (Lykos/MDMA) shows psychedelic NDAs can fail even with strong Phase 3 optics; DEA rescheduling adds a post-approval complication (though not required for FDA approval itself); quantitative modeling (code_execution) suggests fair value closer to 55-64%, below Kalshi's 86%. # Gaps / unknowns - No confirmed PDUFA date exists yet. - Unclear whether functional unblinding (a key Lykos CRL driver) is a live FDA concern for COMP360. - Cash runway/CMC manufacturing readiness not directly sourced. - No corroborating prediction-market cross-checks (Polymarket/Kalshi related markets absent). # Calibration anchors - Kalshi current YES price: 86% (anchor), up from 69% a month ago. - Model-based fair value estimate: ~55–64% (code_execution), notably below market price — suggests possible market overconfidence or model missing recent positive catalysts (CNPV, strong durability data, admin support). - Precedent: Lykos/MDMA CRL (2024) shows psychedelic-therapy NDAs face elevated first-cycle rejection risk despite Breakthrough status.

4. Forecasters Fable 5.1 + GPT-5.6 Sol · in parallel

claude-fable-5-1

52% conf

Yes	74%
No	26%

Kalshi prices YES at 86% after a sharp run-up on strong COMP006 26-week durability data, CNPV selection, and CEO guidance for a 'first part of 2027' launch. The rolling NDA's final tranche is only targeted for Q4 2026, so a sub-July-2027 approval effectively requires the CNPV 1–2 month review goal (or something close to it) to hold — under a standard 8-month priority-review clock a December 2026 completion would push a PDUFA past July 2027. CNPV reviews in 2025 did deliver very fast approvals and the administration is actively pushing psychedelics, and the efficacy/safety package looks cleaner than Lykos/MDMA, so first-cycle approval risk is moderate rather than high. Still, no PDUFA date exists, NDA completion could slip, functional unblinding remains an unaddressed FDA question, and the CNPV timeline is non-binding, so I shade below the market to ~74% rather than the brief's 55–64% model, which likely underweights the CNPV mechanism and political tailwind.

gpt-5.6-sol

68% conf

Yes	78%
No	22%

The rolling NDA and Q4 2026 final-submission target point toward Yes because portions are already under review and the CNPV pilot targets a 1–2 month post-filing review. Positive Phase 3 efficacy, durability, and safety results, combined with Breakthrough Therapy status and supportive administration policy, further favor approval in the first half of 2027. However, the absence of a completed NDA or formal PDUFA date, the nonbinding nature of the expedited-review goal, and meaningful first-cycle risk for a novel CNS psychedelic justify discounting the thin-market Kalshi YES anchor of 86%. DEA rescheduling may delay launch but does not itself prevent FDA approval, so it has little bearing on this event.

5. Devil's Advocate Sonnet 5 · red-team critique

Both forecasters converge tightly (74%/78%) between the Kalshi anchor (86%) and the model estimate (55–64%), but neither explains why they weight the anchor so much more heavily than the code_execution model beyond asserting the model "likely underweights CNPV" — this is asserted, not demonstrated, and the brief itself flags CNPV as a "goal not binding," which cuts against giving it much weight over the model's base-rate approach.

Neither forecast seriously engages with the timeline arithmetic risk: if final NDA submission slips past Q4 2026 (a real possibility given "targeted" language, not committed), even a fast 1–2 month CNPV review could push a PDUFA decision dangerously close to or past July 2027, and neither computes a probability distribution over submission-slippage scenarios explicitly.

Forecast 2's claim that "DEA rescheduling... has little bearing on this event" is correct for the FDA approval question itself, but both forecasters should flag that this event only asks about FDA approval, not launch — yet CEO commentary about "launch first part of 2027" (used as bullish evidence) conflates launch timing with approval timing and may be over-weighted as a proxy for approval speed.

Neither forecaster addresses the Lykos/MDMA CRL precedent with specificity — the brief notes "unclear whether functional unblinding... is a live FDA concern for COMP360," and both forecasters mention this only in passing without adjusting probability for the unresolved unblinding question, which is the single biggest empirical parallel to a prior psychedelic CRL.

Both anchor around ~75-78%, essentially splitting the difference between Kalshi (86%) and the model (55-64%) without justifying why the true midpoint should skew closer to Kalshi rather than to the model, especially given the market is explicitly flagged as "thin" (54 contracts/day) and its 17-point rally in 30 days could reflect momentum/narrative rather than calibrated probability.

Neither considers the base-rate reference class critically: the "60-70% first-cycle CNS approval" figure is explicitly labeled an "analytical assumption, not sourced empirically" in the brief, yet both forecasts treat deviations from this model as if the model's assumptions were solid, when in fact both the market anchor and the model estimate carry significant uncertainty that neither forecast's tight confidence band (0.74-0.78) fully reflects.

6. Aggregator Fable 5.1 · final calibrated forecast

77% (60% confidence)

Yes: 77% No: 23%

The pathway to a pre-July-2027 approval is coherent: rolling NDA already partly under review, final tranche targeted Q4 2026, CNPV pilot with a 1–2 month review goal (which delivered very fast approvals in its 2025 cohort), strong two-trial efficacy/durability/safety data, and an administration and FDA leadership openly pushing psychedelics. Even without the CNPV goal holding, a Q4 2026 completion with 6-month priority review lands around June 2027, so timing fails mainly if submission slips into 2027 or the FDA issues a CRL. The critique correctly notes that the 'launch first part of 2027' guidance conflates launch with approval and that functional-unblinding/CRL risk is unresolved, which justifies discounting the thin, momentum-driven 86% Kalshi price, but it offers no new evidence pointing toward failure; the code_execution 55–64% estimate relies on an unsourced base rate and ignores the CNPV/administration mechanism. Both forecasters drew consistent inferences from the sub-questions, and I land near their consensus at 77% Yes.

Pipeline Timing

Total pipeline time: 235.1s

Per-tool research timings shown in the Research section above.