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

date	predicted	market price	confidence
2026-08-29	72%	79%	66%
2026-08-22	70%	79%	62%
2026-05-10	42%	70%	40%

1. Planner Fable 5.1 · Fermi decomposition + tool plan

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

Sub-questions (Fermi decomposition)

Has Compass Pathways completed or begun the rolling NDA submission for COMP360, and what is the announced or expected NDA submission completion date?
What were the COMP006 Phase 3 26-week results (topline expected 2026) and did COMP005 and COMP006 both meet primary endpoints with acceptable safety/durability?
Has FDA granted priority review or is COMP360 eligible under breakthrough therapy designation, and what PDUFA goal date would that imply relative to July 1, 2027?
What is the FDA's current posture on psychedelic approvals after the August 2024 Lykos MDMA rejection, including any statements from HHS/FDA leadership about expediting psilocybin?
What is the historical base rate of first-cycle FDA approval for CNS/psychiatric NDAs with breakthrough designation, and how often do PDUFA dates slip or receive CRLs?
Does Compass have sufficient cash runway and manufacturing/CMC readiness to avoid delays before mid-2027?

Planner reasoning

COMP360 approval before July 2027 hinges on Compass Pathways' regulatory timeline: whether they filed/will file the NDA (they had announced plans for a rolling submission with potential accelerated timing after COMP005 and COMP006 Phase 3 readouts), whether FDA grants priority review (6-month clock) vs standard (10-month), and how the FDA's post-Lykos-rejection stance on psychedelics and the current administration's stated interest in expediting psychedelics plays out. The Kalshi price is the primary anchor; Compass (CMPS) stock and news flow around NDA submission and PDUFA date are the key empirical signals.

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): 79.00% - 7-day price change: +1.00% - 30-day price change: +3.00% - Average daily volume: 56 contracts - Price range: 69.00% - 94.00% - Data points: 23 days
kalshi_related	OK	2.0s	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	2.0s	0	Scanned 100 active Polymarket markets, kept 0 matches. keyword 'psilocybin': 0 markets \| keyword 'Compass Pathways': 0 markets \| keyword 'COMP360': 0 markets \| keyword 'FDA psychedelic': 0 markets
claude_news	OK	20.0s	12	Based on current research findings on COMP360 (Compass Pathways' psilocybin therapy for treatment-resistant depression): - Both Phase 3 trials succeeded: Both pivotal Phase 3 TRD trials met primary endpoints, with COMP005 showing a -3.6 MADRS difference versus placebo and COMP006 showing a -3.
article_search	OK	2.2s	32	Fetched 32 unique articles across 4 queries (lookback=120d). 'Compass Pathways COMP360 NDA submission FDA': 10 articles \| 'COMP006 phase 3 psilocybin results': 10 articles \| 'FDA psilocybin approval timeline treatment-resistant depression': 10 articles \| 'FDA psychedelics priority review Makary Kenn
gdelt_news	OK	82.2s	10	GDELT: 10 articles across 2 queries (lookback=60d). 'Compass Pathways psilocybin FDA': error GDELT rate-limited after retries (429) \| 'COMP360 approval': 10 hits
earnings_data	OK	2.1s	1	Fetched FMP data for 1 ticker(s).
wikipedia	OK	2.0s	3	Fetched 3 Wikipedia entries (0 missing pages).
code_execution	OK	50.1s	0	## Model Setup & Key Assumptions - NDA submission timing (3 scenarios, weighted): Q4 2025 (30%), Q2 2026 (45%), Q4 2026 (25%) — reflecting COMPASS Pathways' Phase 3 readout/filing guidance. - Review type: Priority review (6-month clock) assumed for 75% of scenarios given Breakthrough Therap

3. Evidence Brief Sonnet 5 · 6756 chars

# Current state COMP360's rolling NDA is underway with final submission targeted for Q4 2026; both pivotal Phase 3 trials (COMP005, COMP006) met primary endpoints with durable 6-month benefit. FDA granted a Commissioner's National Priority Voucher (CNPV) in April 2026 that can compress review to 1-2 months once the NDA is complete, and Compass is targeting commercial launch in H1 2027 — but no PDUFA date has been formally set and approval is not guaranteed. # Timeline of key events - 2024-08: FDA rejects Lykos Therapeutics MDMA NDA for PTSD (confirmed, Wikipedia/background) — dampened psychedelic approval sentiment. - 2024-10: Compass lays off 30% of workforce, narrows focus post-Lykos rejection (confirmed, Wikipedia). - Prior to 2026: COMP360 retains FDA Breakthrough Therapy Designation (confirmed, claude_news). - 2026 (Q1, per SEC 8-K/Q1 press release): Compass progressing toward Phase 3 completion and rolling NDA prep (confirmed, SEC filing). - ~2026-07 (early July): Strong topline Phase 3 (COMP005/COMP006) results reported; COMP005 shows -3.6 MADRS vs placebo, COMP006 -3.8 vs 1mg at Week 6, both p<0.001 (confirmed, stocktitan/CNBC 2026-07-19). - 2026-07-10: COMP006 26-week durability data released, confirming durable response through 6 months in ~600 patients (confirmed, Compass IR/psychiatryadvisor). - 2026-04-18: Trump executive order directs federal agencies to accelerate psychedelic drug therapy review (confirmed, claude_news). - 2026-04-24: FDA issues Commissioner's National Priority Voucher (CNPV) to COMP360 program (confirmed, claude_news) — can compress standard 10-12 month review to 1-2 months post-complete-NDA. - 2026-08-05: Q2 earnings release states rolling NDA submission "underway," final piece targeted Q4 2026; commercial launch expected H1 2027 (confirmed, earnings release per claude_news). - 2026 (undated, exec commentary): FDA Commissioner Makary signals decision could come "late summer or fall 2026" per some reports, while Compass execs say approval decision could land "end of year into next year" (reported/mixed — some inconsistency between sources on exact Makary timing). - No advisory committee announced for COMP360 as of latest research (confirmed absence, claude_news); DEA rescheduling (~90 days) required post-approval (reported). # 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 by then) # Kalshi market anchor **Current YES price: 79%** (as of latest data). 7-day change: +1pt; 30-day change: +3pt (trending up). Average daily volume: 56 contracts (thin). Price range over observed period: 69%-94%, 23 data points — market has been volatile but stabilized in high-70s/low-80s recently. # Sub-question answers 1. **NDA submission status/date**: Rolling NDA submission is underway; final piece targeted for completion Q4 2026 (Compass Q2 2026 earnings release, claude_news/SEC). 2. **COMP006 26-week results**: Both COMP005 and COMP006 met primary endpoints (p<0.001 each) with durable response confirmed through 26 weeks in ~600 patients; generally well-tolerated safety profile (claude_news, stocktitan, psychiatryadvisor 2026-07-10). 3. **Priority review/PDUFA**: COMP360 retains Breakthrough Therapy Designation and was granted a CNPV (April 2026) that can compress review to 1-2 months post-complete-NDA; no formal PDUFA date disclosed yet, though execs suggest decision "end of year into next year" (claude_news). 4. **FDA posture post-Lykos**: Trump executive order (April 2026) explicitly directs faster psychedelic review, reversing prior caution after the 2024 Lykos MDMA rejection; Commissioner Makary reportedly optimistic on timing, though critics (Harvard Petrie-Flom) warn the voucher doesn't guarantee approval (claude_news, CNBC 2026-05-31). 5. **Base rates**: No explicit external base-rate data found; internal model (code_execution) assumes ~65% first-cycle approval probability for BTD psychiatric NDAs, 35% CRL rate with 85% second-cycle approval conditional. 6. **Cash runway/CMC readiness**: Not directly addressed in research; CEO states company will be "launch-ready" by end of 2026 including commercial infrastructure, implying manufacturing/CMC readiness is on track (CNBC 2026-07-19), but no explicit cash runway figures found. # Key facts (high-confidence, factual) 1. [claude_news/stocktitan] Both Phase 3 trials met primary endpoints with durable 26-week benefit. 2. [claude_news] CNPV granted April 24, 2026, following Trump's April 18 EO on psychedelics. 3. [claude_news] Rolling NDA final submission targeted Q4 2026; commercial launch targeted H1 2027. 4. [Wikipedia] COMP360 holds Breakthrough Therapy Designation. 5. [Wikipedia] 2024 Lykos MDMA CRL created industry headwinds, since partially reversed by 2026 policy shift. # Cross-market signals - Kalshi related: No related psilocybin/Compass markets found (0 matches). - Polymarket: No matching markets found (0 matches). - Sportsbook implied: N/A (not applicable to FDA approvals). # Analyst opinions and speculation - Jefferies bullish on COMP360 post-data (proactiveinvestors 2026-07-17). - Harvard Petrie-Flom researchers caution CNPV accelerates process but doesn't guarantee approval. - Model (code_execution) estimates ~75-78% probability of approval before July 2027, sensitive mainly to NDA filing timing; Q4 2026 filing scenario only clears deadline under priority review with no CRL/extension. # Directional lean per outcome - **Yes**: Strong Phase 3 data, BTD, CNPV compression mechanism, favorable political tailwind (Trump EO), company guidance toward H1 2027 launch — all support approval before deadline. - **No**: No confirmed PDUFA date; Q4 2026 filing timeline leaves thin margin before July 2027 deadline if any review extension or CRL occurs; post-Lykos regulatory caution and lack of announced adcom add uncertainty; DEA rescheduling adds ~90 days post-approval (though rescheduling isn't the resolution criterion, only FDA approval is). # Gaps / unknowns - No confirmed PDUFA date or NDA acceptance date. - Exact final NDA submission completion date (Q4 2026) not pinned down further. - No explicit cash runway/CMC data found. - No historical base-rate data specifically for psychiatric BTD-first-cycle approvals from external sources (only model assumption). # Calibration anchors - Kalshi current YES price: **79%** (primary anchor). - Internal model estimate: ~75-78% (range 67-83% under sensitivity). - Historical BTD first-cycle approval assumption: ~65% (model-internal, unverified externally). - Precedent: Lykos MDMA (also BTD, psychedelic-adjacent) received CRL in Aug 2024 despite BTD — a cautionary precedent for optimism.

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

claude-fable-5-1

52% conf

Yes	74%
No	26%

Both pivotal Phase 3 trials met primary endpoints (p<0.001) with durable 26-week benefit, COMP360 holds BTD plus a CNPV that can compress review to 1-2 months, and Compass guides to a complete NDA in Q4 2026 with an H1 2027 launch — all consistent with approval before July 2027. The Kalshi anchor of 79% reflects this, but the margin is thin: without CNPV compression actually materializing, a Q4 2026 filing under even standard priority review would land near or past the deadline, and any filing slip, CRL (Lykos precedent, modest ~3.6-point MADRS effect, functional unblinding, REMS complexity), or review extension pushes resolution to No. No PDUFA date has been disclosed, which the market may be underweighting. I land slightly below the anchor at 74%.

gpt-5.6-sol

72% conf

Yes	78%
No	22%

The rolling NDA and targeted Q4 2026 completion point toward Yes, although the unconfirmed submission and PDUFA dates create schedule risk. Both pivotal trials met their primary endpoints with durable 26-week benefit, supporting approvability, while Breakthrough Therapy status, the CNPV, and the favorable federal posture support a decision before July 2027. However, a late-Q4 filing, review extension, or first-cycle CRL could miss the deadline, and the Lykos rejection shows that psychedelic-adjacent designations do not guarantee approval. I therefore stay close to the 79% Kalshi YES anchor but trim slightly to 78%, consistent with the brief's 75-78% internal model range.

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

Both forecasters anchor tightly around the Kalshi 79% price without independently modeling the timeline math: if CNPV compression (1-2 months) actually applies after a Q4 2026 complete NDA, resolution lands around Jan-Feb 2027 with comfortable buffer to July 2027 — the "thin margin" framing in Forecast 1 undersells this upside scenario and overweights the standard-review counterfactual.

Neither forecast addresses NDA filing acceptance risk: FDA typically takes ~60 days to accept a submission for review before the clock (and any PDUFA date) starts, which could meaningfully delay even a Q4 2026 "final piece" submission — this friction point is absent from both rationales.

The brief flags a direct inconsistency — Commissioner Makary reportedly suggested "late summer or fall 2026" while Compass execs say "end of year into next year" — neither forecaster explicitly reconciles or weights this discrepancy, which bears directly on whether approval clears the July 2027 bar with margin or barely squeaks by.

The internal base-rate model (65% first-cycle, 35% CRL with 85% second-cycle conditional approval) implies ~95% eventual approval probability, but this conflates "ever approved" with "approved by July 2027 deadline" — neither forecast decomposes timing risk separately from ultimate approval likelihood, potentially overstating confidence in hitting the specific window.

Both cite the Lykos MDMA CRL as a cautionary precedent but neither examines why it may be a weak analogy (efficacy blinding/functional unblinding issues, REMS/safety database concerns specific to MDMA) versus COMP360's cleaner p<0.001 durable Phase 3 results, potentially over-weighting a negative reference class.

Neither forecast substantively discusses the no-advisory-committee status as a genuine unknown risk (an adcom could still be called late in the process, adding months) versus a positive signal (its absence to date may suggest FDA doesn't intend one) — this ambiguity is underexplored despite being flagged in the brief as adding uncertainty.

6. Aggregator Fable 5.1 · final calibrated forecast

76% (62% confidence)

Yes: 76% No: 24%

Both forecasts converge near the 79% Kalshi anchor, and the critique does not expose a shared directional flaw—its points cut both ways (CNPV compression upside vs. filing-acceptance lag and possible late adcom). Decomposing: the Yes path requires (a) a first-cycle approval, which strong p<0.001 dual-Phase-3 data, BTD, and the Trump EO/CNPV posture make likely (~80-85%, with Lykos a weak analogy given its unblinding/REMS-specific issues), and (b) the CNPV actually compressing review, since a late-Q4 2026 filing under standard priority review would land at or past July 2027 (~90% conditional). The unconfirmed PDUFA date and unpinned Q4 completion date are genuine schedule risks the thin market may slightly underweight, so I trim modestly below the anchor. Final: Yes 76%, No 24%.

Pipeline Timing

Total pipeline time: 176.9s

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