Scan: When will the FDA approve COMP360 Psilocybin for Treatment-Resistant Depression?

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

KXFDAAPPROVALDATECMPS-360-27JUL01 · Science and Technology · 2026-05-10

42%

Agent

70%

Market Price

-28.0%

Edge

40%

Confidence

Volume: 6,125

Spread: 5.0c

Days to resolution: 416

Markets in event: 3

Final Rationale

My independent forecast of 24.7% had genuine decomposition flaws that the critique correctly identified: SQ3 and SQ4 double-counted CRL/REMS/political risks, the CNPV mechanism (explicitly granted to COMPASS with a designed 1-2 month review) was underweighted, and DEA scheduling was conflated with FDA approval itself (the question asks about FDA approval, not commercial launch). Accepting challenges 1, 2, and 3 fully and challenge 4 partially moves my estimate to ~40-42%. I diverge from the 70% market because (a) the market spiked from ~10% to 70% in 30 days on CNPV news with anomalous orderbook depth and a $0.98 spread suggesting low reliability, (b) the timeline remains genuinely tight — NDA likely filed Q4 2026/Q1 2027 with CNPV review still untested in practice, and (c) Lykos demonstrated FDA willingness to reject psychedelics even with positive signals. The market appears to be pricing CNPV as near-certain success, which I find unjustified given execution risk on a novel review pathway.

Price vs. prediction

How the market moved after the agent's call. Solid blue line is the actual market price; dashed line is the agent's static forecast at $t{=}0$.

$n = 58$ follow-ups

Re-scan Context

This market has been scanned before. Previous predictions:

Date	Predicted	Market Price	Confidence
2026-05-03	30%	73%	50%
2026-04-23	22%	49%	50%

1. Planner Opus · Fermi decomposition + tool plan

Tools chosen: kalshi_data kalshi_orderbook article_search web_search earnings_data wikipedia_lookup code_execution

Sub-questions (Fermi decomposition)

Has COMPASS Pathways submitted or will it submit an NDA to the FDA for COMP360 before January 2027? (w=0.35)
Has COMP360 demonstrated sufficient Phase 3 efficacy and safety data to support FDA approval for Treatment-Resistant Depression? (w=0.30)
Will the FDA complete its review of COMP360 and grant approval before July 1, 2027, given that an NDA is filed? (w=0.20)
Will regulatory and scheduling obstacles be resolved to allow FDA approval of COMP360 by July 2027? (w=0.15)

Planner reasoning

This question requires a multi-stage pipeline analysis: (1) Has COMPASS Pathways completed Phase 3 trials with positive results? (2) Will they file an NDA in time for FDA to complete review by July 2027? (3) Will the FDA actually approve it given the novel regulatory landscape for Schedule I psychedelics? The MDMA/PTSD approval attempt by Lykos Therapeutics was rejected by FDA in August 2024, setting a cautionary precedent. COMP360 Phase 2b results showed mixed outcomes. For approval by July 2027, an NDA would need to be filed no later than roughly July-September 2026 for standard review, or January 2027 for priority review. The timeline is extremely tight. Key risks include Schedule I DEA classification requiring parallel scheduling action, REMS program requirements, and heightened FDA scrutiny post-MDMA rejection. The combination of pipeline stage uncertainty, regulatory novelty, and tight timeline makes this very unlikely.

2. Research Parallel tool calls · legacy v2

Tool	Status	Time	Items
kalshi_data	OK	2.0s	-
kalshi_orderbook	OK	0.2s	-
article_search	OK	0.8s	-
web_search	OK	70.8s	-
earnings_data	OK	0.9s	-
wikipedia_lookup	OK	2.0s	-
code_execution	OK	0.0s	-

3. Evidence Synthesis Sonnet · 22 items · legacy v2

#	Strength	Credibility	Direction	Source	Claim	Priced In
1	STRONG	85	↑ UP	web_search	COMPASS Pathways completed two positive Phase 3 trials (COMP005 in June 2025, COMP006 in February 2026) and is guiding to rolling NDA submission completion in Q4 2026, with final 26-week durability data expected in early Q3 2026.	Yes
2	STRONG	82	↑ UP	web_search	COMPASS Pathways expects a potential FDA approval decision in late 2026 or early 2027 — 9-12 months earlier than previously anticipated — implying NDA filing well before January 2027.	Yes
3	MODERATE	78	↑ UP	web_search	On March 24, 2026, COMPASS announced a formal FDA meeting scheduled to confirm its NDA submission strategy, suggesting submission is imminent but not yet complete.	No
4	STRONG	88	↑ UP	web_search	The FDA granted COMPASS Pathways' rolling NDA review request for COMP360 as of approximately April 24, 2026, meaning the NDA process has formally begun but is not yet complete.	No
5	MODERATE	70	NEUTRAL	code_execution	A standard 12-month FDA review requires NDA filing by July 1, 2026 for approval before July 2027; with the Commissioner's National Priority Voucher (1-2 month review), filing deadline could extend to approximately January 2027.	Yes
6	STRONG	88	↑ UP	web_search	COMP360 hit primary endpoints with high statistical significance in both COMP005 (June 2025) and COMP006 (February 2026) Phase 3 trials, across more than 1,000 participants with treatment-resistant depression.	Yes
7	STRONG	85	↑ UP	web_search	COMP360 is described as the first classic psychedelic to consistently achieve highly statistically significant and clinically meaningful results across two Phase 3 studies, with effects lasting at least 6 months.	Yes
8	STRONG	90	↑ UP	web_search	COMPASS holds Breakthrough Therapy Designation from the FDA for COMP360 in TRD, which was granted based on earlier clinical data and supports the regulatory pathway.	Yes
9	MODERATE	72	↓ DOWN	article_search	FDA has recently rejected or discouraged at least 8 drug applications in the past year (as of March 2026), citing insufficient evidence — raising concerns about FDA scrutiny standards for novel drug applications.	Yes
10	MODERATE	80	↓ DOWN	web_search	The 26-week durability data from COMP006 Part B — critical for the NDA package — is expected only in early Q3 2026, meaning the full efficacy dataset is not yet available.	No
11	STRONG	88	↑ UP	article_search	The FDA granted COMP360 a Commissioner's National Priority Voucher on April 24, 2026, which provides a shortened 1-2 month review time following NDA filing, dramatically compressing the timeline.	No
12	MODERATE	65	↑ UP	web_search	If the CNPV truly offers 1-2 month review after NDA filing, and the NDA is completed in Q4 2026, approval could potentially occur in early 2027 — within the before-July-2027 window.	No
13	MODERATE	75	↑ UP	web_search	COMPASS Pathways itself guided to a potential approval decision in late 2026 or early 2027 — which is consistent with, but not confirming, approval before July 2027.	Yes
14	WEAK	58	NEUTRAL	article_search	FDA under Trump is moving away from advisory committee reviews for drug approvals, which could speed or complicate the review process for novel drugs like COMP360.	Yes
15	MODERATE	55	↑ UP	kalshi_data	The Kalshi market for COMP360 FDA approval before July 2027 is currently priced at 70%, up +60% over 30 days but down -10% over 7 days, with high liquidity (depth=15510).	No
16	WEAK	35	NEUTRAL	kalshi_orderbook	The Kalshi orderbook shows extremely wide bid-ask spread ($0.98), with yes_bid and no_bid both at $0.01, suggesting the market may be illiquid or the orderbook data is anomalous despite high depth.	No
17	STRONG	82	↓ DOWN	web_search	On February 4, 2026, Trump administration officials removed COMP360 from the FDA's Priority Voucher program just hours before its announcement — psilocybin was the only drug vetoed from the original 10 — revealing political resistance to psychedelic approval.	Yes
18	MODERATE	80	↑ UP	web_search	COMP360 was ultimately added back to the CNPV program in the April 2026 round, suggesting political resistance was overcome but the episode illustrates ongoing regulatory uncertainty.	No
19	STRONG	85	↓ DOWN	web_search	Psilocybin remains a DEA Schedule I controlled substance, requiring parallel DEA scheduling action for any approval — a process with uncertain timelines that is not addressed by FDA action alone.	Yes
20	STRONG	88	↓ DOWN	article_search	The FDA rejected Lykos Therapeutics' MDMA/PTSD application in August 2024, setting a cautionary precedent for psychedelic drug approvals and establishing heightened evidentiary standards.	Yes
21	MODERATE	72	↑ UP	article_search	Psilocybin has received growing societal and political support, with the FDA actively fast-tracking review for multiple psilocybin applications in April 2026, suggesting political winds have shifted in favor.	No
22	MODERATE	78	↑ UP	web_search	A positive Type B meeting between COMPASS and FDA occurred in September 2025, confirming the regulatory pathway and submission strategy — a strong procedural signal of alignment.	Yes

Information Gaps

Exact date of rolling NDA completion for COMP360 — currently guided for Q4 2026 but not confirmed, and this is the single most critical variable for the July 2027 deadline
Specifics of the Commissioner's National Priority Voucher mechanism — whether the 1-2 month review clock starts at NDA acceptance or completion, and whether FDA has formally committed to this timeline for COMP360
Status and timeline of DEA scheduling action for psilocybin, which must parallel or follow FDA approval and could independently block approval even if FDA acts
Details of the COMP006 Part B 26-week durability data expected in early Q3 2026 — whether it will be available in time for Q4 2026 NDA completion
Whether REMS (Risk Evaluation and Mitigation Strategy) program requirements have been negotiated with FDA, which could slow approval
Full efficacy and safety profile of COMP360 vs. placebo including any safety signals from Phase 3 that could complicate review
Clarity on the FDA's internal review capacity and staffing under the Trump administration's DOGE-related cuts, which could affect review timelines

Key Uncertainties

Whether the CNPV 1-2 month review is credible and legally binding — this program is brand new and untested, so actual review timelines remain uncertain
Whether the rolling NDA will be completed in Q4 2026 as guided — delays in the 26-week COMP006 data (expected early Q3 2026) could push submission into Q1 2027 or later
DEA scheduling action timeline — historically takes 6-12+ months and is not synchronous with FDA review, potentially blocking practical approval even if FDA approves
Whether the Trump administration's political ambivalence (initial veto, then reinstatement) signals continued interference risk that could delay or block approval
Whether FDA will require additional data or impose a Complete Response Letter (CRL), given novel precedent and complex therapy delivery model (requires therapist support)
How seriously to weight the Kalshi 70% price given the anomalous orderbook (both bids at $0.01) — the +60% 30-day price spike may reflect the April 2026 CNPV news being incorporated suddenly into a thin market

Market Context

Price: 0.7 · 7d: -0.10 · 30d: +0.60
Volume: MODERATE — 236 avg daily contracts, active but not deep · Depth: ANOMALOUS — depth=15510 but both yes_bid and no_bid at $0.01 with $0.98 spread, suggesting possible data artifact or market structure issue
Reliability: LOW-MEDIUM — the 30-day price spike from ~4-10% to 70% appears driven by the April 2026 CNPV news; the market has only 26 days of data and the anomalous orderbook reduces confidence in the price as a reliable probability signal. The 7-day decline of -10% may reflect partial mean-reversion after initial euphoria.

4. Independent Forecaster Opus · No market price · legacy v2 Did NOT see market price

Independent estimate: 25% (50% confidence)

base rate

22%

50% conf

evidence driven

32%

45% conf

contrarian

20%

55% conf

Spread

12pp

Moderate

sq1: Will COMPASS submit NDA before January 2027?

82%

Base rate for biotech meeting self-guided NDA timelines within ~6 months: ~60-70%. Strong evidence: rolling NDA review already accepted by FDA (April 2026), two positive Phase 3 trials completed, company guiding Q4 2026 completion. Rolling NDA submissions reduce risk because modules are submitted progressively. Risk: 26-week durability data expected early Q3 2026 could slip, pushing completion into Q1 2027. Even with 2-3 month slip, would likely make January 2027. Final: 82%.

sq2: Sufficient Phase 3 efficacy/safety to support approval?

78%

Base rate for drugs with positive Phase 3 + Breakthrough Designation getting FDA approval: ~80-85%. Both Phase 3 trials hit primary endpoints with high statistical significance across 1,000+ patients with 6-month durability — exceptionally strong data. Lykos precedent (MDMA) creates psychedelic-specific scrutiny — pushes down ~5-7%. Functional unblinding concerns intrinsic to psychedelics remain. 26-week data still pending. Final: 78%.

sq3: FDA completes review and approves before July 1, 2027 given NDA filed?

50%

Conditional on NDA filed by ~Jan 2027 with sufficient data. Standard Priority Review is 6 months from acceptance (~July 2027 if filed Jan 2027 — very tight). CNPV claims 1-2 month review but is novel/untested. Base rate for first-cycle approval on Priority Review: ~60-70%. Novel psychedelic, REMS negotiations, and DEA scheduling parallel process create delay risk. CRL risk meaningful. Even with CNPV, the 'approval before July 2027' window is tight if NDA completes Q4 2026 (~6-9 months window). Final: 50%.

sq4: Regulatory/scheduling obstacles resolved by July 2027?

55%

DEA scheduling is the biggest concern — historically takes 6-12+ months after FDA approval and required for marketing. However, DEA can act in parallel and has done so for prior controlled substances. Political volatility (Trump admin removed then reinstated CNPV) shows interference risk. Lykos precedent looms. Recent positive signals: FDA fast-tracking psilocybin applications, positive Type B meeting, CNPV granted. Weighted across sub-factors: scheduling resolved (~60%), no political block (~75%), REMS negotiated in time (~70%), no CRL on novel grounds (~70%). Weighted average ~55%.

Show full reasoning trace

base rate: Base rate for novel drug approval within ~14 months of expected NDA filing in a politically sensitive Schedule I category: roughly 15-25%. Most drugs experience some delay; first-cycle approval rates are ~60-70% but timing slips are common.

evidence updates: Strong upside: two positive Phase 3 trials, rolling NDA accepted, CNPV granted, Breakthrough Designation. Strong downside: Lykos MDMA rejection precedent, DEA scheduling timing, political volatility (Trump admin veto/reinstatement), tight timeline requires near-perfect execution, untested CNPV mechanism.

combination method: Conditional chain multiplication with adjustment for positive correlation between sub-questions (strong data → faster review and fewer obstacles).

final: Despite remarkable positive Phase 3 results and CNPV status, the combination of timeline tightness, DEA scheduling requirement, novel psychedelic regulatory landscape, and political uncertainty makes approval before July 2027 a minority outcome. Estimate 22%.

ensemble: {'ensemble_count': 3, 'perspectives': {'base_rate': {'p_yes': 0.22, 'confidence': 0.5}, 'evidence_driven': {'p_yes': 0.32, 'confidence': 0.45}, 'contrarian': {'p_yes': 0.2, 'confidence': 0.55}}, 'spread': 0.12, 'individual_p_yes': {'base_rate': 0.22, 'evidence_driven': 0.32, 'contrarian': 0.2}}

5. Devil's Advocate Sonnet · legacy v2 Market price revealed

Asymmetric Evidence Reasoning Flaw

Challenges

The conditional chain may be double-counting downside risks. SQ3 (50%) already captures FDA review timing including CRL risk and REMS, while SQ4 (55%) again discounts for CRL, REMS, and political block. Multiplying 0.82 × 0.78 × 0.50 × 0.55 = 17.6% likely understates because these factors overlap. A cleaner decomposition (NDA filed in time × approval given filing) would avoid this.
The CNPV is materially underweighted. If CNPV genuinely compresses review to 1-2 months (FDA has publicly committed to this framework), then even an NDA completion in Q1 2027 could yield approval before July 2027. The forecaster treats CNPV as 'novel/untested' and barely moves SQ3 above 50%, but CNPV was specifically designed for this purpose and COMPASS was explicitly granted it.
SQ4's DEA scheduling concern may be miscalibrated for THIS question. The question is about FDA approval, not commercial launch. DEA scheduling typically follows FDA approval and is not a precondition for FDA's approval decision itself. The forecaster appears to conflate 'approval' with 'marketable approval,' which could be inflating the downside by ~10-15%.
The Lykos precedent is arguably overweighted. Lykos failed primarily on functional unblinding, trial conduct issues, and lack of efficacy replication. COMP360 has TWO positive Phase 3s with high statistical significance — structurally different from Lykos's single pivotal trial concerns. Treating Lykos as a -5-7% drag on SQ2 may be appropriate, but it shouldn't also independently weigh on SQ4.
SQ1 at 82% may actually be conservative given rolling NDA acceptance is already in hand (April 2026) and modules can be submitted progressively. The bottleneck is the 26-week durability data in Q3 2026, but rolling submission means non-durability modules are likely already filed.

Suggested adjustment: +12pp

Independent of market price, the decomposition appears to double-count downside risks across SQ3 and SQ4 (CRL risk, REMS, political block all appear in both), and likely conflates FDA approval with DEA scheduling completion. Additionally, the CNPV mechanism — explicitly granted to COMP360 with a designed 1-2 month review — is given insufficient credit in SQ3. Correcting these issues alone moves the forecast to roughly 0.35-0.40. This is a reasoning-based adjustment, not a market-conformity adjustment.

Market comparison: Forecaster: 24.7%, Market: 70%. Divergence is large (-45pp). The market price likely overweights the CNPV news (priced in over 30 days from ~10% to 70%) and may underweight DEA/political/CRL risks. However, the forecaster's decomposition has genuine flaws (double-counting, CNPV underweighting, FDA-vs-DEA conflation) that justify moving up modestly. A reasoned forecast in the 35-45% range seems more defensible than either 25% or 70%.

6. Aggregator Opus · final calibrated forecast

42% (40% confidence)