Events

TRUE on the date of the sponsor's topline release, the ClinicalTrials.gov results posting or the peer-reviewed publication that first reports that MAPP1 (NCT03537014), the first Phase 3 trial of MDMA-assisted therapy for PTSD, met its prespecified primary endpoint (change in CAPS-5 total severity score versus placebo with therapy) with statistical significance as reported by the sponsor. FALSE on the date the sponsor first reports that the primary endpoint was not met, and FALSE at the deadline when no primary-endpoint result has been reported. Secondary endpoints, interim analyses and pooled analyses do not count. Resolution source: the ClinicalTrials.gov record NCT03537014 (results section), with the sponsor's topline press release or the first publication fixing the date.

ClinicalTrials.gov record NCT03537014 (results); sponsor topline press release or first publication as the secondary source

TRUE on the date of the first sponsor topline press release, ClinicalTrials.gov results posting or peer-reviewed publication that reports a Phase 3 trial of a psychedelic drug (MDMA, psilocybin, LSD or another classic psychedelic or entactogen) given with psychotherapy, for any indication and under any sponsor, as having met its prespecified primary efficacy endpoint with statistical significance as reported by the sponsor. Phase 2 trials, secondary endpoints, interim analyses and pooled analyses do not count. Resolution source: the sponsor's topline release, with ClinicalTrials.gov results for the same trial. FALSE at the deadline when no such report exists.

Sponsor topline press release; ClinicalTrials.gov results

TRUE on the date the DEA issues a Schedule I bulk manufacturer registration for the manufacture of marijuana for research to any applicant other than the NIDA contract facility at the University of Mississippi, as published in the Federal Register or announced by the DEA Diversion Control Division. A DEA policy statement that it will accept applications, or an acceptance of an application for filing, is not a registration. Resolution source: the Federal Register DEA registration notices. FALSE at the deadline when no such registration has been issued.

Federal Register (DEA registration notices); DEA Diversion Control Division announcements

TRUE on the earliest of (a) the date the sponsor (MAPS or MAPS PBC), the Bronx VA or the study's investigators publicly state that the DEA registration for the Bronx VA MDMA-assisted therapy for PTSD study has been granted, (b) the date a sponsor or VA announcement reports that the study has begun dosing or enrolling participants at the Bronx VA (dosing MDMA requires the registration), or (c) the date ClinicalTrials.gov first lists the Bronx VA site for that study with status Recruiting. A statement that the registration is pending, an IRB approval or a protocol approval is not the DEA registration. Resolution source: MAPS announcements and the ClinicalTrials.gov site status for that study. FALSE at the deadline when none of these has appeared.

MAPS announcements (press releases, MAPS Bulletin) and ClinicalTrials.gov site status for the Bronx VA MDMA/PTSD study

TRUE on the date of the sponsor's topline release, the ClinicalTrials.gov results posting or the peer-reviewed publication that first reports that MAPP2 (NCT04077437), the second Phase 3 trial of MDMA-assisted therapy for PTSD, met its prespecified primary endpoint (change in CAPS-5 total severity score versus placebo with therapy) with statistical significance as reported by the sponsor. FALSE on the date the sponsor first reports that the primary endpoint was not met, and FALSE at the deadline when no primary-endpoint result has been reported. Secondary endpoints, interim analyses and pooled analyses do not count. Resolution source: the ClinicalTrials.gov record NCT04077437 (results section), with the sponsor's topline press release or the first publication fixing the date.

ClinicalTrials.gov record NCT04077437 (results); sponsor topline press release or first publication as the secondary source

TRUE on the earlier of (a) the date of a sponsor press release that announces the first participant enrolled or dosed in a trial registered as Phase 3 on ClinicalTrials.gov or the EU Clinical Trials Register whose investigational product is psilocybin, for any indication, or (b) the actual study start date recorded for such a trial on ClinicalTrials.gov. Registration alone (status Not yet recruiting), a Phase 2/3 label with no Phase 3 portion under way, and an announcement of plans do not count. Resolution source: ClinicalTrials.gov, with the sponsor press release as a secondary source. FALSE at the deadline when no Phase 3 trial of a psilocybin drug product has started.

ClinicalTrials.gov; sponsor press release as a secondary source

TRUE on the effective date of a published medical policy, coverage bulletin or fee schedule from a US health plan (a Blue Cross Blue Shield plan or another commercial or public payer) that lists an accelerated TMS protocol (multiple sessions per day, such as SAINT/SNT or SWIFT) as medically necessary for at least one of post-traumatic stress disorder, bipolar disorder, obsessive-compulsive disorder or attention-deficit/hyperactivity disorder. Coverage of conventional once-daily TMS for these indications does not count, and coverage of accelerated TMS for depression alone does not count. FALSE at the deadline when no such policy has taken effect by then. Resolved on the payer's published policy bulletin.

US health plan medical policy bulletins (Blue Cross Blue Shield plan policy libraries and other payer policy sites)

TRUE on the Federal Register publication date (or the DEA announcement date, if earlier) of a temporary rule or order that extends the COVID-era telemedicine flexibilities for prescribing controlled substances beyond the end of the COVID-19 public health emergency, so that the Ryan Haight Act in-person visit requirement does not return for telehealth patients at the PHE end. A proposed rule is not an extension. FALSE when the flexibilities expire at the PHE end with no such rule or order published, and FALSE at the deadline when no extension appears in the Federal Register. Resolution source: the Federal Register.

Federal Register

TRUE on the effective date of a Medicare inpatient prospective payment system (IPPS) final rule, published in the Federal Register by CMS, that approves a New Technology Add-On Payment for SAINT Neuromodulation. The proposed rule, the open comment period, a coding assignment or a national coverage analysis is not approval. Resolution source: the Federal Register (CMS Medicare IPPS final rule, NTAP determinations). FALSE at the deadline when no IPPS final rule approving an NTAP for SAINT Neuromodulation has been published.

Federal Register (CMS Medicare IPPS final rule, NTAP determinations)

TRUE on the effective date of a published payer policy document, dated after 2022-09-07, under which a US health plan or Medicare pays for treatment with the SAINT neuromodulation system (fMRI-guided accelerated intermittent theta-burst stimulation, Magnus Medical): a national or local coverage determination, a Medicare fee schedule or add-on payment, or a commercial plan's public medical policy bulletin that lists the treatment as covered. A CPT or HCPCS code assignment on its own, a proposed rule, a pilot, a single case-by-case or appeal approval, and a manufacturer statement are not a coverage policy. Resolution source: the CMS Medicare Coverage Database for Medicare policies, and the payer's own public medical policy bulletin for a commercial plan. FALSE at the deadline when no such policy is published.

CMS Medicare Coverage Database (NCD and LCD records and fee schedule rules), and the payer's own public medical policy bulletin for a commercial plan

TRUE on the earlier of (a) the ClinicalTrials.gov study start date of the first interventional Phase 3 (or Phase 2/3) trial of midomafetamine (MDMA) for post-traumatic stress disorder whose sponsor is not MAPS Public Benefit Corporation, MAPS, or a successor or licensee of their program, and (b) the date of the definitive public announcement (press release or SEC filing) that such a sponsor has filed its own US marketing application for MDMA for PTSD on its own clinical data. Trials run by MAPS PBC or its successor, trials of MDMA for other indications, Phase 1 or Phase 2 trials, an application that relies on the MAPS program's data, a rumour and a letter of intent do not count. Resolution source: ClinicalTrials.gov, with the sponsor's press release as a secondary source. FALSE at the deadline when no such trial or application is on record.

ClinicalTrials.gov; sponsor press release or SEC filing as a secondary source

TRUE on the Federal Register publication date of a second DEA rule or order that extends the COVID-era telemedicine flexibilities for prescribing controlled substances beyond the end date set by the first extension. Requires that a first extension exists. A proposed rule is not an extension; a permanent final rule that replaces the flexibilities is not an extension. FALSE at the deadline when no second extension has been published in the Federal Register, including when the flexibilities lapse at the end date set by the first extension. Resolution source: the Federal Register.

Federal Register

TRUE on the docket date of a verdict, sentence, judgment, consent order or filed settlement in which a US federal or state court, or a federal or state enforcement agency (for example the Department of Justice, the DEA, the FTC, a state attorney general or a state medical board), convicts, sanctions, enters judgment against, or accepts a settlement or consent order from Cerebral, Inc. or a current or former Cerebral executive over Cerebral's controlled-substance prescribing or business practices. A subpoena, an announced investigation, an unresolved complaint or indictment, a private lawsuit or a voluntary policy change by Cerebral does not count. Resolution source: the court docket on CourtListener or PACER, with the DOJ or agency press release fixing the date of an agency settlement or order. FALSE at the deadline when no such docket entry or agency order exists.

Court docket (CourtListener or PACER); DOJ or agency press release as a secondary source

TRUE on the date of Magnus Medical's definitive public announcement (press release) that the SAINT neuromodulation system is commercially available in the United States, or that the first commercial, non-trial patient has been treated with it at a US clinic. FDA clearance alone, a waitlist or limited-release notice, a research-only installation or a rumor does not count. Resolution source: Magnus Medical press releases. FALSE at the deadline when no such announcement has been made.

Magnus Medical press releases

TRUE on the date of the definitive public announcement (Magnus Medical press release or the hospital's own public announcement) that SAINT is available to patients in a US hospital setting (inpatient or hospital outpatient department), or that a first patient has been treated with SAINT at a US hospital. Availability only through a Magnus Medical research or open-label study at non-hospital clinics, a hospital's stated intention or agreement to install without patient availability, and any CMS payment decision by itself do not count. Resolution source: Magnus Medical press releases, with the adopting hospital's public announcement as a secondary source. FALSE at the deadline when no such announcement has been made.

Magnus Medical press releases; adopting hospital's public announcement as a secondary source

TRUE on the effective date of a published medical policy, coverage bulletin or fee schedule from a US health plan that is not one of the seven plans the forecaster listed on 16 May 2026 (Premera, Highmark, CareFirst, and the Blue Cross Blue Shield plans of California, South Carolina, Texas and Vermont) and that lists an accelerated TMS protocol (multiple sessions per day, such as SAINT/SNT or SWIFT) as medically necessary for any indication. A policy update or expansion by one of the seven listed plans does not count; coverage of conventional once-daily TMS does not count. FALSE at the deadline when no such policy has taken effect by then. Resolved on the payer's published policy bulletin.

US health plan medical policy bulletins (Blue Cross Blue Shield plan policy libraries and other payer policy sites)

TRUE on the date of the first sponsor topline release, ClinicalTrials.gov results posting or peer-reviewed publication dated after 2022-07-11 that reports a randomized controlled trial of SNT (Stanford Neuromodulation Therapy, the accelerated intermittent theta-burst TMS protocol commercialized by Magnus Medical) or another accelerated iTBS protocol for a depressive disorder, distinct from the Stanford SNT trial already published at the statement date, in which the prespecified primary efficacy endpoint met statistical significance versus the control arm as reported by the sponsor or the authors. Open-label series, secondary endpoints and pooled analyses do not count. Resolution source: the trial's ClinicalTrials.gov record and results posting, with the first peer-reviewed publication or sponsor release fixing the date. FALSE at the deadline when no such trial result has been reported.

ClinicalTrials.gov record and results posting of the trial; peer-reviewed publication or sponsor release as the secondary source

TRUE on the date of the first sponsor topline release, ClinicalTrials.gov results posting or peer-reviewed publication, dated after the statement date, that reports a randomized controlled trial of SNT or another accelerated TMS protocol (more than one session per day) in bipolar depression whose prespecified primary efficacy endpoint met statistical significance as reported by the sponsor. Open-label series, single-arm series and secondary endpoints do not count. FALSE at the deadline when no such result is reported. Resolved on ClinicalTrials.gov results postings and the first peer-reviewed publication or sponsor release.

ClinicalTrials.gov results posting; peer-reviewed publication or sponsor release

TRUE on the date of an FDA written action (complete response letter, refuse-to-file letter or other written FDA communication the sponsor discloses), an FDA review document posted on Drugs@FDA, or an FDA advisory committee briefing document that names failure or loss of the double-blind (functional unblinding, or expectancy bias from unblinding) in the Phase 3 trials of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, as a reason the efficacy results are not adequate for approval. A document that only asks a question about blinding, without treating it as a deficiency, does not count. Resolution source: Drugs@FDA (action letters and review documents) with the FDA advisory committee materials page. FALSE when the FDA approves the application with no such finding, or when no such document exists at the deadline.

Drugs@FDA (action letters, review documents); FDA advisory committee materials

TRUE on the date of the FDA's first action letter (an approval letter or a complete response letter) on a new drug application for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder, under any sponsor name, as dated in Drugs@FDA or announced by the sponsor. NDA submission, filing acceptance, a PDUFA date assignment, an advisory committee meeting or a refuse-to-file letter is not an action on the application. FALSE at the deadline when no such action letter is dated. Resolution source: Drugs@FDA, with the sponsor's press release as a secondary source.

Drugs@FDA; sponsor press release as a secondary source

TRUE on the date the sponsor (Lykos Therapeutics) publicly discloses, or the FDA publicly states, that the FDA's action letter on the midomafetamine NDA under review on the statement date cites insufficient or missing safety data or requests additional safety data, alone or together with other deficiencies. FALSE on the date the FDA approves that NDA in the pending review cycle, on the date the sponsor's or the FDA's disclosed summary of the action letter names only deficiencies that do not concern safety data, or at the deadline when no FDA action letter on that NDA has been disclosed. A PDUFA date extension or a request for more review time is not the event. If the FDA has acted but neither the sponsor nor the FDA discloses the grounds within 12 months after the action, the event is unresolvable.

Lykos Therapeutics press releases and public statements describing the FDA action letter; FDA public statements as a secondary source

TRUE on the docket date of the first civil complaint (including a patient or shareholder class action) or government civil or criminal action filed on or after 2024-09-04 against Acadia Healthcare or a subsidiary, or the date of the Acadia Healthcare SEC filing that first discloses such an action, in which the allegations include holding psychiatric patients against their will or beyond medical necessity as described in the New York Times investigation the author discusses. Suits that do not allege that conduct (for example ordinary malpractice claims), suits filed before 2024-09-04, and subpoenas or investigations without a filed action do not count. FALSE when no such action has been filed or disclosed by the deadline.

Court dockets (CourtListener, PACER); Acadia Healthcare SEC filings (legal proceedings)

TRUE on the Federal Register publication date of a DEA action on its February 2023 proposed rule on telemedicine prescribing of controlled substances without a prior in-person medical evaluation that departs from finalizing the proposal as written: a final rule whose operative requirements differ materially from the proposal (for example on the in-person evaluation requirement), a formal withdrawal of the proposal, or a new proposed rule that supersedes it. A temporary rule or order that only extends existing flexibilities while the proposal stays pending is not a revision, withdrawal or replacement of the proposal. FALSE on the Federal Register publication date of a final rule that adopts the February 2023 proposal without material change, and FALSE at the deadline when the proposal has been neither revised, withdrawn nor replaced. Resolution source: the Federal Register.

Federal Register

Resolved on the named data series only: worldwide net trade sales of Spravato (esketamine nasal spray) in Johnson & Johnson's product-sales tables in its periodic reports on SEC EDGAR (Form 10-K and 10-Q) and the sales exhibits of its quarterly earnings releases (Form 8-K). TRUE on the date of the first Johnson & Johnson report that shows Spravato worldwide net sales at or above US$1 billion for a calendar year. 'Blockbuster' in the forecaster's words is read as US$1 billion of annual sales, the standard industry meaning, so the event resolves as binary at US$1 billion with no band. FALSE at the deadline when no completed calendar year has reached US$1 billion in the reported series. Unresolvable if the series stops and no figure has published 12 months after the deadline. Realized values are stored, not scored.

Johnson & Johnson product sales tables in its Form 10-K, Form 10-Q and earnings-release exhibits on SEC EDGAR

TRUE on the date of the definitive public announcement (press release, SEC filing or a filed Form D) by Lykos Therapeutics, or by the renamed or successor company that holds the midomafetamine (MDMA-assisted therapy) NDA program, of a completed equity, debt or grant financing of any size closed after 31 October 2024. A letter of intent, a rumor or a financing by MAPS (the nonprofit) alone does not count. FALSE at the deadline when no such announcement exists.

Company press release; SEC EDGAR (Form D)

TRUE on the date of the first Compass Pathways topline press release, ClinicalTrials.gov results posting or peer-reviewed publication that reports the primary endpoint result, in either direction, of a Phase 3 trial of COMP360 (synthetic psilocybin) in treatment-resistant depression. A Phase 2 result, an enrollment or trial-start announcement, a guidance statement on the expected readout date, an interim safety report and a conference abstract without the primary estimate do not count. Resolution source: Compass Pathways press releases, with ClinicalTrials.gov results as the secondary source. FALSE at the deadline when no such report is dated by then.

Compass Pathways topline press releases; ClinicalTrials.gov results as the secondary source

TRUE on the date of the first Compass Pathways topline press release, ClinicalTrials.gov results posting or peer-reviewed publication that reports a Phase 3 trial of COMP360 (synthetic psilocybin) in treatment-resistant depression as having met its prespecified primary efficacy endpoint with statistical significance against the control arm, as reported by the sponsor. A Phase 2 result, a secondary endpoint, an interim analysis, a long-term follow-up report and a conference abstract without the primary estimate do not count. Resolution source: Compass Pathways topline press releases, with ClinicalTrials.gov results as the secondary source. FALSE at the deadline when the first reported Phase 3 primary endpoint missed significance, or when no Phase 3 primary result is reported.

Compass Pathways topline press releases; ClinicalTrials.gov results as the secondary source

TRUE on the date of the first sponsor topline press release, ClinicalTrials.gov results posting or peer-reviewed publication that reports the primary endpoint result, positive or negative, of the Phase 2b randomized controlled trial of BPL-003 (intranasal 5-MeO-DMT) in treatment-resistant depression sponsored by Beckley Psytech, its parent company or a successor sponsor of BPL-003. Phase 2a or open-label results, an interim or pooled analysis, a trial-start or enrollment announcement, and a conference abstract that omits the primary endpoint result do not count. Resolution source: the sponsor's topline press release, with the trial's ClinicalTrials.gov record as the secondary source. FALSE at the deadline when no primary endpoint result of that trial has been reported.

Beckley Psytech topline press release; ClinicalTrials.gov record of the trial as the secondary source

Resolved on the named data series only: the Nasdaq daily closing price of atai Life Sciences common stock (ATAI, or its successor listing), adjusted for any split or reverse split. The reference price is the ATAI Nasdaq close on 2025-05-16. TRUE on the first trading day after the statement date on which the closing price is at or above 2.0 times the reference price. The threshold is in the forecaster's words ('a multiple of where it trades today', read at its lower bound of two times), so it resolves as binary at 2.0 with no band. FALSE at the window end when no close has reached 2.0 times the reference price. If the shares stop trading with no successor listing and no price series has published 12 months after the window end, the event is unresolvable. Realized values are stored, not scored.

Nasdaq daily closing prices for ATAI (or successor listing)

TRUE on the date of the first public report of topline results of the Phase 2b trial of RL-007 in cognitive impairment associated with schizophrenia: the topline press release of Recognify Life Sciences or atai Life Sciences, the ClinicalTrials.gov results posting, or the publication that first reports the result. The direction of the result does not matter; the event is the readout. Enrolment or last-patient-out news, an interim or blinded update, a safety update, and a conference abstract without the primary-endpoint result do not count. FALSE at the deadline when no topline result has been reported. Resolution source: the sponsor's topline press release, with the ClinicalTrials.gov record of the trial fixing the date if the sponsor publishes none.

Recognify Life Sciences / atai Life Sciences topline press release; ClinicalTrials.gov record of the RL-007 Phase 2b CIAS trial

TRUE on the date of the first sponsor topline press release, ClinicalTrials.gov results posting or peer-reviewed publication that reports a two-dose induction regimen of BPL-003 (intranasal 5-MeO-DMT) in treatment-resistant depression with a larger point-estimate reduction from baseline in the MADRS total score, at the primary timepoint, than the estimate the sponsor reported for the corresponding single active dose in the BPL-003 Phase 2b trial the forecaster describes. The comparison is on the reported point estimates; statistical significance of the difference is not required. FALSE on the date the sponsor first reports a two-dose induction estimate that is not larger, and FALSE at the deadline when no two-dose induction data have been reported.

Sponsor topline press release; ClinicalTrials.gov results or peer-reviewed publication as a secondary source

TRUE on the date of the first sponsor press release, investor presentation, conference presentation, ClinicalTrials.gov results posting or peer-reviewed publication that reports outcome data from open-label dosing of BPL-003 (intranasal 5-MeO-DMT), including an open-label extension of the Phase 2b programme in treatment-resistant depression. At least one quantitative open-label outcome (for example a MADRS change, a response rate or a remission rate) must be reported. A statement that open-label data exist or are coming, a schedule or guidance with no data, and a safety-only listing do not count. FALSE at the deadline when no such report has appeared.

Sponsor press release or investor presentation; ClinicalTrials.gov results as a secondary source

TRUE on the date of the first peer-reviewed publication (PubMed-indexed) or ClinicalTrials.gov results posting, dated after 2026-01-15, that reports primary-outcome results of a randomized controlled trial of the Monarch eTNS (external trigeminal nerve stimulation) device in one of the indications the forecaster names as cleared (ADHD in youth, or refractory seizures), designed to test the efficacy finding of the trial that supported the existing FDA clearance, and randomizing more participants than that pivotal trial. Any direction of result counts. Secondary analyses of earlier trials, open-label studies, and results already public on the statement date do not count. FALSE at the deadline when no such publication or posting is dated by then. Resolution source: PubMed (peer-reviewed publication), with ClinicalTrials.gov results as a secondary source.

PubMed (peer-reviewed publication); ClinicalTrials.gov results as a secondary source

TRUE on the date of the first sponsor or investigator topline press release, ClinicalTrials.gov results posting or peer-reviewed publication, dated after 2026-01-01, that reports primary-outcome results (positive, negative or mixed) of a clinical trial of a Brainsonix transcranial focused ultrasound device in human participants. Trial-start or enrollment announcements, preclinical or healthy-volunteer mechanistic data without a clinical primary outcome, conference teasers without primary-outcome results, and results already public on the statement date do not count. Resolution source: Brainsonix press releases, with ClinicalTrials.gov results and PubMed as secondary sources. FALSE when no such topline result has been reported by the deadline.

Brainsonix press releases (company newsroom); ClinicalTrials.gov results and PubMed as secondary sources

TRUE on the date of the first atai Life Sciences (or successor company) press release, ClinicalTrials.gov results posting or peer-reviewed publication that reports the primary-endpoint result of the Phase 2 trial of EMP-01 (oral R-MDMA) in social anxiety disorder, in any direction; the sponsor's topline release is the primary source. 'Positive' means the prespecified primary endpoint met significance as reported by the sponsor; the direction is stored, not required. A trial start, an enrollment update, an interim safety report or a conference teaser without the primary-endpoint result does not count. FALSE at the deadline when no such topline result has been reported.

atai Life Sciences (or successor company) press releases; ClinicalTrials.gov results posting as a secondary source

Resolved on the named data series only: atai Life Sciences press releases (SEC filings as the secondary source). TRUE on the date of the fourth press release announcing topline results of a Phase 2 trial of a programme atai sponsors, directly or through a company it controls or partners with (for example Beckley Psytech or Recognify Life Sciences), counted over announcements dated 20 March 2025 to 20 March 2026 inclusive. Each trial counts once; Phase 1 readouts, interim analyses and open-label extension reports do not count. FALSE at the window end when fewer than four such topline announcements have appeared. If no such release series has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

atai Life Sciences press releases; SEC EDGAR filings as a secondary source

TRUE on the meeting date stated in the sponsor's public announcement (press release, SEC filing or investor presentation) that the End-of-Phase-2 (End-of-Phase-2b) meeting with the FDA for BPL-003 (intranasal 5-MeO-DMT, mebufotenin) has been held; when the announcement gives no meeting date, the announcement date counts. An FDA written-response-only outcome counts when the sponsor reports it as that End-of-Phase-2 interaction. A granted meeting request, a scheduled but unheld date, a meeting on another program, and a rumour do not count. The sponsor is atai Life Sciences under any corporate name, including AtaiBeckley or a successor. FALSE at the deadline when no such announcement exists.

atai Life Sciences press releases; SEC EDGAR filings

TRUE on the docket date of a complaint filed in a US federal district court within the window that (a) pleads a claim under ERISA for breach of fiduciary duty against the sponsor, plan committee or other named fiduciaries of an employer-sponsored group health plan over the plan's design or administration, whether brought by plan participants or by the Department of Labor, and (b) cites the Mental Health Parity and Addiction Equity Act (MHPAEA, 'mental health parity') as a basis of the alleged breach, as shown by the complaint text. A suit only for denied benefits under ERISA section 502(a)(1)(B) against an insurer or administrator, a state-court suit, or an amended complaint in a case filed before the window does not count. Legal press reports are a finding aid only. FALSE when no such complaint has been filed by the deadline.

Federal court dockets (CourtListener / PACER)

TRUE on the date of the index provider's announcement (an addition notice or a reconstitution list) that names AtaiBeckley (atai Life Sciences, Nasdaq: ATAI) as an addition to a major stock market index, read as: the S&P 500, S&P MidCap 400 or S&P SmallCap 600; the Russell 1000, 2000 or 3000; the Nasdaq-100 or the Nasdaq Biotechnology Index; or an MSCI standard or small-cap country, regional or world index. An index of which ATAI was already a constituent on the statement date, a thematic or custom index built for one fund, or a total-market index that admits every listed stock automatically (for example the Nasdaq Composite) does not count. FALSE at the deadline when no such announcement is dated by then. Resolution source: the index provider's announcement (S&P Dow Jones Indices, FTSE Russell, Nasdaq or MSCI); the company's press release or SEC filing as a secondary source.

Index provider announcements (S&P Dow Jones Indices, FTSE Russell, Nasdaq, MSCI); AtaiBeckley press release or SEC filing as a secondary source

TRUE on the decision date in the FDA 510(k), De Novo or PMA database of a marketing authorization, dated after 2024-01-04, for a transcranial magnetic stimulation device whose indications-for-use statement names a disease or condition that no TMS device was authorized for on 2024-01-04. Conditions already authorized at the statement date (major depressive disorder including treatment-resistant depression, anxious depression, smoking cessation, obsessive-compulsive disorder, migraine for single-pulse TMS) do not count. A new population or protocol within an authorized condition, a breakthrough designation, an investigational device exemption or a non-US authorization does not count. Resolution source: the FDA 510(k) Premarket Notification database, with the De Novo and PMA databases for other pathways. FALSE at the deadline when no such authorization appears there.

FDA 510(k) Premarket Notification database; De Novo and PMA databases for other pathways

TRUE on the docket date on which the second qualifying case is filed. A qualifying case is a federal criminal case (indictment, information or complaint) filed after the statement date by US federal prosecutors against a company that sells or prescribes controlled substances (manufacturer, distributor, pharmacy, or telehealth or clinic prescriber), or against its principals, on charges about that sale, distribution or prescribing, as in the Done Global prosecution. Each qualifying case is a distinct docket against a different company. Civil or DEA administrative actions, settlements without charges, superseding indictments in an existing case, and the pending Done Global case do not count. FALSE at the deadline when fewer than two qualifying cases have been filed by then. Resolution source: federal court dockets (CourtListener/PACER); DOJ press releases as a secondary source.

Federal court dockets (CourtListener/PACER); DOJ press releases as a secondary source

TRUE on the date of the sponsor's topline press release, ClinicalTrials.gov results posting or peer-reviewed publication that first reports, after 7 May 2026, the primary endpoint result of a Phase 3 trial of DT120 (MM120, lysergide) for any indication, when that report states that the prespecified primary endpoint was met with statistical significance as reported by the sponsor. FALSE on that date when the report states the primary endpoint was not met. Only the first Phase 3 topline reported after 7 May 2026 resolves the event; secondary endpoints, interim analyses and open-label data do not count.

Sponsor topline press release; ClinicalTrials.gov results; peer-reviewed publication

TRUE on the date of the definitive public announcement (atai press release or SEC filing) of a partnership, collaboration, co-development or licensing agreement between atai Life Sciences, under any corporate name including AtaiBeckley or a successor, and a large pharmaceutical company, for one of atai's psychedelic programs. A large pharmaceutical company is one with annual revenue at or above US$10 billion in its last reported fiscal year. Rumours, letters of intent and non-binding term sheets do not count. An equity investment, a financing, a supply contract or a service contract without a program agreement does not count. FALSE at the deadline when no such announcement exists.

atai Life Sciences press releases; SEC EDGAR filings

TRUE on the date of the first public report of the Voyage trial's primary endpoint result: Definium Therapeutics' topline press release, a results posting on the ClinicalTrials.gov record NCT06741228, or the first peer-reviewed publication that reports the primary result, whichever is first. The result may be positive or negative; the event is about a primary result being reported. An enrollment-complete or last-patient-visit announcement, an interim safety update, a conference abstract without the primary endpoint estimate, or a readout of a different DT120 trial (for example the MDD trial EMERGE) does not count. FALSE at the deadline when no such report is dated by then. Resolution source: Definium Therapeutics' topline press release, with the ClinicalTrials.gov record NCT06741228 as a secondary source.

Definium Therapeutics topline press release; ClinicalTrials.gov record NCT06741228 as secondary source

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder is dated, on any review cycle and under any sponsor name. A complete response letter, a positive advisory vote, a filing acceptance, a breakthrough designation or an expanded-access program is not an approval. A label narrower than PTSD (for example a PTSD subgroup or severity band) counts if the claim's indication reasonably includes it and the reading is logged at intake; a label that requires a REMS or a psychological-intervention component counts. Resolution source: Drugs@FDA, with the sponsor's press release as a secondary source. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA; sponsor press release as a secondary source

TRUE on the date of the first FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a drug product whose active ingredient is psilocybin, for any indication and under any sponsor (COMP360 by Compass Pathways, or another psilocybin product). A complete response letter, a positive advisory vote, a breakthrough therapy designation, a filing acceptance or a state program that permits psilocybin use is not an FDA approval. Approval of a psilocybin analogue (for example a deuterated psilocybin) or of another tryptamine (5-MeO-DMT, DMT) does not count. Resolution source: Drugs@FDA. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA

TRUE on the earlier of the date of a CHMP positive opinion recommending marketing authorisation, or the date of the European Commission marketing authorisation decision, for a midomafetamine (MDMA) product for post-traumatic stress disorder, under any sponsor name. A negative opinion, a withdrawal of the application, a PRIME designation, a national compassionate-use scheme or a single-country authorisation is not EU approval. A label narrower than PTSD counts if it names a PTSD population and the reading is logged. Resolution source: the EMA medicines database (EPAR pages), with the European Commission Union Register as the secondary source for the Commission decision date. FALSE at the deadline when neither a CHMP positive opinion nor a Commission authorisation for midomafetamine for PTSD is recorded there.

EMA medicines database (EPAR); European Commission Union Register as a secondary source

TRUE on the Federal Register publication date of a DEA final rule (or the effective date of an enacted statute that the DEA implements) that permits a practitioner to prescribe controlled substances to patients located in a state where the practitioner holds no DEA registration at a physical location, on a non-emergency basis. A proposed rule, a temporary emergency exception, or the extension of an emergency exception is not adoption. Resolution source: the Federal Register. FALSE at the deadline when no such final rule has been published in the Federal Register.

Federal Register

TRUE on the date of the definitive public announcement (SEC filing, press release or court filing) that BetterHelp ceases operations, or that Teladoc Health files for bankruptcy or is dissolved. A fine, a settlement, a stock decline, a write-down or a sale of BetterHelp as a going concern does not count. Resolution source: SEC EDGAR filings of Teladoc Health, with the company press release or bankruptcy docket as a secondary source. FALSE at the deadline when BetterHelp still operates and Teladoc Health has not filed for bankruptcy or been dissolved.

SEC EDGAR (Teladoc Health filings); company press release or bankruptcy docket as a secondary source

TRUE on the publication date of an American Psychiatric Association practice guideline, or guideline update, for major depressive disorder that recommends TMS (any protocol, including accelerated protocols) or another non-ECT neuromodulation modality as a first-line treatment option, that is, as an initial treatment not conditioned on prior antidepressant failure. A draft for comment, a payer policy, or a recommendation limited to treatment-resistant depression is not adoption. Resolution source: the APA Practice Guidelines (psychiatryonline.org). FALSE at the deadline when no such APA guideline has been published.

American Psychiatric Association Practice Guidelines (psychiatryonline.org)

TRUE on the effective date (1 October of the fiscal year) of the Medicare inpatient prospective payment system (IPPS) final rule, published in the Federal Register by CMS, that approves a new technology add-on payment for a psychedelic-class drug (psilocybin, MDMA, LSD, DMT or a related compound) or for a therapy that administers one. An NTAP application, a proposed rule, a CPT code, an FDA approval, a Medicaid or commercial payer decision, or a payment for ketamine or esketamine does not count. Resolution source: the Federal Register, Medicare IPPS final rule, new technology add-on payment section. FALSE at the deadline when no such NTAP approval has been published.

Federal Register (Medicare IPPS final rule, new technology add-on payment section)

TRUE on the date of the first definitive public statement by the sponsor of PCN-101 (atai Life Sciences, its subsidiary Perception Neuroscience, or a successor owner or licensee of the asset), in a press release, SEC filing or investor presentation, that development of PCN-101 (arketamine, R-ketamine) is discontinued or terminated, or that the program has been removed from the pipeline with no further development planned. A missed endpoint, a pause pending data, a search for a partner, or a deprioritization that keeps the program under evaluation is not discontinuation. Development that continues under a licensee or new owner of the asset is not discontinuation. Resolution source: atai Life Sciences press releases and SEC filings (EDGAR). FALSE at the deadline when no such discontinuation statement has been made.

atai Life Sciences press releases and SEC filings (EDGAR)

TRUE on the date of the first public report of the primary endpoint result (sponsor topline press release, ClinicalTrials.gov results posting or peer-reviewed publication, whichever is first) of a Phase 3 trial of midomafetamine (MDMA-assisted therapy) for PTSD whose ClinicalTrials.gov start date is after 2024-06-05. The result may be positive or negative. The two Phase 3 trials discussed at the 4 June 2024 advisory committee (MAPP1, MAPP2) do not count; a trial start, an enrollment announcement or an FDA request for a trial does not count. Resolution source: ClinicalTrials.gov, with the sponsor's topline press release as a secondary source. FALSE at the deadline when no such trial has reported a primary endpoint result.

ClinicalTrials.gov; sponsor topline press release as a secondary source

Resolved on the FDA REMS database (REMS@FDA) read together with Drugs@FDA. For each drug in the psychedelic class (MDMA or midomafetamine, psilocybin, ibogaine and any other compound its sponsor or the FDA describes as a psychedelic or an entactogen; esketamine and ketamine excluded) that receives FDA approval between the statement date and the item's deadline, check whether a REMS is in force on the approval date. FALSE on the date of the first such approval that has no REMS. TRUE at the deadline if every such approval carried a REMS. If no drug in the class is approved by the deadline, the condition is unmet and the item is void. Resolution source: REMS@FDA, with Drugs@FDA for the approval dates.

FDA REMS database (REMS@FDA), with Drugs@FDA for approval dates

TRUE on the date of the first FDA approval letter or Drugs@FDA entry (the sponsor's approval announcement is the secondary source) for a drug in the psychedelic class: MDMA (midomafetamine), psilocybin, ibogaine, or another compound that its sponsor or the FDA describes as a psychedelic or an entactogen; esketamine and ketamine are excluded. Any indication counts. A complete response letter, a positive advisory vote, a filing acceptance or a breakthrough therapy designation is not an approval. FALSE when no such approval appears in Drugs@FDA by the deadline.

Drugs@FDA; sponsor press release as a secondary source

TRUE on the date of a Department of Justice press release (justice.gov) announcing an indictment or criminal complaint against a telehealth or digital health company, or its executives, for unlawful distribution of controlled substances prescribed through the company's platform, in a case other than the Done case the author cites. The docket date of the charging document is the secondary source. Civil settlements, DEA administrative actions, state actions and cases against individual clinicians with no company platform do not count. FALSE when no such announcement has appeared by the deadline.

US Department of Justice press releases; federal court dockets (CourtListener) as a secondary source

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) adds PTSD or PTSD-associated nightmares or sleep disturbance to the labeled indications of any prazosin product. A complete response letter, a positive advisory vote or a filing acceptance is not an approval. Off-label use, a clinical guideline, a compendium listing or a VA/DoD recommendation is not an FDA label. A label limited to PTSD-associated nightmares counts, since the claim's context concerns nightmares. FALSE when no such indication appears on a prazosin label in Drugs@FDA by the deadline.

Drugs@FDA; sponsor press release as a secondary source

Resolved on the named data series only: the market capitalization of atai Life Sciences (Nasdaq: ATAI, or its successor listing), computed as the Nasdaq closing share price multiplied by the shares outstanding stated on the cover page of atai's most recent periodic SEC filing on EDGAR. TRUE on the first trading day on which that closing market capitalization is at or above US$10 billion. The threshold is in the forecaster's words, so it resolves as binary at US$10 billion with no band. FALSE at the deadline when no market close has reached US$10 billion. If the shares stop trading with no successor listing and no price series has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

Nasdaq closing price for ATAI and shares outstanding in atai Life Sciences periodic filings on SEC EDGAR

TRUE on the date the FDA approval letter or Drugs@FDA entry, or the approval entry in the database of another major regulator (EMA, MHRA, TGA or another national agency), or atai's approval announcement, is dated for a psychedelic therapeutic, for any indication, that atai Life Sciences (or its successor company) developed, owns, or holds under a licence, co-development or partnering agreement at the time of approval. A psychedelic therapeutic is a compound its sponsor or the regulator describes as a psychedelic or an entactogen; esketamine and ketamine are excluded. A complete response letter, a positive advisory vote or opinion, a filing acceptance, a designation, or a compassionate or special-access scheme is not an approval. FALSE when no such approval appears in Drugs@FDA or another major regulator's database by the deadline.

Drugs@FDA or the approving regulator's database; atai Life Sciences press release as a secondary source

TRUE on the date of the FDA's written decision (or, if that letter is not public, the sponsor's public announcement of it) that grants the request for reconsideration or the formal dispute resolution appeal of the August 2024 complete response letter: the FDA withdraws its request for an additional Phase 3 trial or approves the NDA on the data already submitted. A meeting granted or held, a resubmission accepted for review, or an approval that follows a new Phase 3 trial does not count. If no reconsideration request or appeal is decided in the sponsor's favour by the end of the window, the event is FALSE.

Lykos Therapeutics press releases; FDA CDER formal dispute resolution decision letters

TRUE on the docket date of the first criminal indictment, information or complaint (or the date of the Department of Justice or state attorney general press release announcing the charges) that names Acadia Healthcare, a subsidiary, or a current or former Acadia employee or executive as a criminal defendant for conduct that includes holding psychiatric patients against their will or beyond medical necessity, as alleged in the New York Times investigation of Acadia Healthcare that the author discusses. A civil suit, a civil settlement, a CMS or state licensing action, a subpoena, or an announced investigation without charges does not count. FALSE when no such charge appears on a court docket or in a prosecutor's announcement by the deadline.

Court dockets (CourtListener, PACER); DOJ and state attorney general press releases

TRUE on the docket date of the first complaint filed in a US federal or state court, or the announcement date of the first enforcement action by the US Department of Labor, a state attorney general or a state insurance regulator, that names UnitedHealthcare, United Behavioral Health or Optum as defendant or respondent and alleges that pre-payment review (post-service, pre-payment claim review) of mental health or substance use disorder claims violates the Mental Health Parity and Addiction Equity Act or a state mental health parity law. Actions about prior authorization or other utilization review that do not name pre-payment review do not count. A filed complaint counts; no verdict, order or settlement is needed. Regulator press releases are a secondary source. FALSE when no such complaint or action has been filed or announced by the deadline.

CourtListener (RECAP federal and state dockets); DOL/EBSA and New York Attorney General press releases as secondary

TRUE on the date the FDA approval letter or the Drugs@FDA entry (or the sponsor's approval announcement) is dated for an application that adds a bipolar disorder indication to the xanomeline-trospium (Cobenfy) label. Any bipolar I or bipolar II indication counts (for example, acute manic or mixed episodes, depressive episodes, or maintenance), as monotherapy or as an adjunct, and the reading is logged. A complete response letter, a positive advisory vote, a filing acceptance, a trial start or a trial result is not an approval. Approval by a regulator other than the FDA does not count. FALSE when no such indication appears on the Cobenfy label in Drugs@FDA by the deadline.

Drugs@FDA (xanomeline-trospium / Cobenfy approval letters and labeling); Bristol Myers Squibb press release as a secondary source

TRUE on the date of the first public report of the Early-TMS trial's primary outcome result: the peer-reviewed primary results publication, or the investigators' topline release or a results posting in the trial registry named in the Becker-Sadzio et al. 2025 protocol, whichever is first. The result may favour either arm or neither; the event is about a primary result being reported. The protocol publication, a recruitment update, an interim safety report or a conference abstract without the primary outcome estimate does not count. Resolution source: the peer-reviewed Early-TMS primary results publication (PubMed), with the trial registry entry named in the protocol as the secondary source. FALSE when no primary outcome result has been reported by the deadline.

Early-TMS primary results publication (PubMed); trial registry entry named in the Becker-Sadzio et al. 2025 protocol as secondary source

TRUE on the docket date of the first complaint filed in a US federal or state court (CourtListener or PACER; the state court docket when filed in state court) that names Cigna, Evernorth or a Cigna health plan as a defendant and that challenges, or alleges harm from, the adolescent TMS coverage policy's requirement of prior antidepressant trials (medication failure) for adolescents. A regulatory complaint, a demand letter, an internal appeal or an external review request is not a lawsuit. The plaintiff type (parent, patient, class) and the cause of action (ERISA or state law) are not restricted. FALSE when no such complaint has been filed by the deadline.

Court dockets (CourtListener, PACER; state court dockets)

Resolved on Cigna/Evernorth's published medical coverage policy for transcranial magnetic stimulation (coverage policy bulletin). TRUE on the effective date of a revised policy that no longer requires prior antidepressant trials (medication failure) before TMS for adolescents with depression, at minimum for ages 15 to 18, the range in the author's proposed rewrite. A revision that only reduces the number of required trials, an individual case exception, or a change by another payer does not count. FALSE at the deadline when the policy in force still requires prior antidepressant trials for adolescents.

Cigna/Evernorth published medical coverage policy for TMS (coverage policy bulletin)

TRUE on the decision date, in the FDA 510(k) or De Novo database (Devices@FDA), of a clearance or De Novo grant for PRISM (GrayMatters Health) whose indications for use name the treatment of depression (major depressive disorder or another depressive disorder), alone or with other conditions. The sponsor's announcement is the secondary source. A breakthrough device designation, a clearance limited to another indication, an investigational device exemption or a CE mark does not count. The intended use must name depression; the claim names no care setting, so any setting in the cleared labeling counts. FALSE when no such clearance appears in Devices@FDA by the deadline.

Devices@FDA (510(k) and De Novo databases); GrayMatters Health press release as a secondary source

TRUE on the date of the FDA approval letter or Drugs@FDA supplement entry (the sponsor's approval announcement is the secondary source) that adds a PTSD indication for brexpiprazole used in combination with sertraline. A complete response letter, a positive advisory committee vote or a filing acceptance is not an approval; a complete response letter does not resolve the event FALSE, the event stays open to the end of the window. A label that names PTSD with any sertraline co-administration wording counts. FALSE when no such indication appears in Drugs@FDA by the deadline.

Drugs@FDA; sponsor press release as a secondary source

TRUE on the effective date of a UnitedHealthcare medical policy or coverage determination guideline, published in UnitedHealthcare's provider policy library, that lists an accelerated TMS protocol (more than one TMS session per day, including accelerated iTBS or fMRI-guided SAINT-type protocols) as proven or medically necessary for major depressive disorder. A policy that covers only standard once-daily TMS, an individual case exception, coverage limited to a clinical trial, or a policy of another payer does not count. FALSE at the deadline when no such UnitedHealthcare policy is in force.

UnitedHealthcare medical policies and coverage determination guidelines (UHCprovider.com policy library)

TRUE on the date S.1717, or another bill that carries the operative text of S.1717 (a Medicare coverage pathway for FDA breakthrough-designated products), is signed into law or otherwise becomes law, as recorded on Congress.gov. Passage by one chamber, committee action, or inclusion in a bill that is not enacted does not count. FALSE when no such enactment is recorded on Congress.gov by the deadline.

Congress.gov

TRUE on the docket date of a jury verdict of guilty, or of a guilty plea entered and accepted by the court, on any count of the December 2025 federal indictment of Done Global and Mindful Mental Wellness P.A. (the indictment announced in the DOJ press release the post annotates), against Done Global as a corporate defendant or against any Done Global executive charged in that indictment. A superseding indictment in the same case is the same case. Convictions in the earlier Done case, convictions of co-defendants other than Done Global or its executives, deferred-prosecution or non-prosecution agreements, civil settlements and dismissals do not count. FALSE on the docket date of the disposition of the last count against the Done Global defendants without a conviction or plea, or at the deadline when no such conviction has been entered.

Federal court docket for the December 2025 Done Global and Mindful Mental Wellness P.A. indictment (PACER via CourtListener); DOJ press releases as a secondary source

Resolved on the named data series only: the calendar-year total of disclosed venture investment into AI-enabled BCI and neuromodulation health-tech companies, taken from the same source and with the same company definition that the forecaster's post uses for its 2025 baseline of over US$300 million. TRUE when that source's figure for calendar 2026 is at or above US$600 million; the threshold (double the 2025 baseline) resolves as binary, with no band. FALSE when that source's figure for calendar 2026 is below US$600 million. If the source has not published a 2026 figure 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

The venture-funding source the forecaster's post cites for its 2025 baseline figure (over US$300 million)

TRUE on the date of the FDA approval letter (Drugs@FDA entry; Compass Pathways' approval announcement as a secondary source) for COMP360 (psilocybin) with an indication in major depressive disorder, including treatment-resistant depression or another MDD subpopulation. A complete response letter, a positive advisory committee vote, filing acceptance, priority review or breakthrough therapy designation is not approval. An approval for an indication outside the depressive disorders (for example PTSD alone) does not count. FALSE at the deadline when no such approval is dated in Drugs@FDA by then. Resolution source: Drugs@FDA.

Drugs@FDA; Compass Pathways press release as a secondary source

TRUE on the date of the FDA approval letter (Drugs@FDA entry; NRx Pharmaceuticals' approval announcement as a secondary source) of NRx Pharmaceuticals' new drug application for its intravenous ketamine product (KetaFree) with an indication in a depressive disorder (major depressive disorder, including depression with suicidal ideation or treatment-resistant depression). A complete response letter, filing acceptance, a tentative approval, or a marketing authorization without a depressive-disorder indication is not approval. FALSE at the deadline when no such approval is dated in Drugs@FDA by then. Resolution source: Drugs@FDA.

Drugs@FDA; NRx Pharmaceuticals press release as a secondary source

Resolved on IQVIA global antidepressant volume data only (IQVIA MIDAS, as published by IQVIA or the IQVIA Institute in its global medicine-use reports). TRUE if the published global antidepressant volume for calendar year 2026 (prescriptions, or the report's standard-unit or defined-daily-dose measure for antidepressants, ATC N06A) is lower than the published figure for calendar year 2025 in the same series and unit; FALSE if it is equal or higher. A direction resolves as binary at the prior-year value. Regional or single-country series do not count. If the series has not published both years' values 12 months after the deadline, the event is unresolvable.

IQVIA global antidepressant volume (IQVIA MIDAS), as published by IQVIA or the IQVIA Institute

TRUE on the effective date of (a) a published medical policy, bulletin or fee schedule of a US health payer with national scope (a national commercial insurer or a federal program) that lists an accelerated TMS protocol (more than one session per day, e.g. accelerated iTBS or SAINT/SNT) as covered or medically necessary in an outpatient clinic, or (b) a public announcement by such a payer, alone or with a provider, of a pilot or network agreement that pays for accelerated TMS in outpatient clinics. Once-daily TMS coverage, trial-only coverage, case exceptions, a single-state or regional plan, an unpublished contract, or inpatient-only coverage does not count. FALSE at the deadline when no such policy or announcement is dated by then. Resolution source: the payer's policy bulletin or fee schedule, or the payer's or provider's press release for the agreement.

The payer's published medical policy bulletin or fee schedule; payer or provider press release for a pilot or network agreement

TRUE on the publication date of an official policy statement, clinical practice guideline, clinical report or public warning issued by the American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP), or another professional society whose members care for children or adolescents, that recommends against, or advises clinicians not to prescribe, antidepressants other than fluoxetine for depression in children and/or adolescents, as shown by the document text. A guideline that ranks fluoxetine first while still endorsing other antidepressants, a statement about a single drug, an individual member's editorial, or an FDA action does not count. FALSE at the deadline when no such document has been published by then. Resolution source: the issuing society's official publication or website (AAP: Pediatrics, aap.org; AACAP: JAACAP, aacap.org).

The issuing society's official publication or website (AAP: Pediatrics, aap.org; AACAP: JAACAP, aacap.org)

TRUE on the date of the first sponsor topline press release, ClinicalTrials.gov results posting or peer-reviewed publication, dated after 2026-01-01, that reports primary-outcome results (positive, negative or mixed) of a clinical trial of a Sanmai transcranial focused ultrasound treatment in human participants. Trial-start or enrollment announcements, preclinical or healthy-volunteer mechanistic data without a clinical primary outcome, conference teasers without primary-outcome results, and results already public on the statement date do not count. FALSE at the deadline when no such report is dated by then. Resolution source: Sanmai press releases, with ClinicalTrials.gov results and PubMed as secondary sources.

Sanmai press releases (company newsroom); ClinicalTrials.gov results and PubMed as secondary sources

Resolved on FDA device authorization records and sponsor announcements only. Count the distinct hardware devices that, at the period end, (a) hold an FDA marketing authorization (510(k) clearance, De Novo grant or PMA approval, per the FDA 510(k), De Novo and PMA databases) whose indications for use name a depressive disorder (major depressive disorder or depression) and home use or use outside a clinical setting, and (b) are commercially available to patients in the United States per the sponsor's public announcement (press release or product website). TRUE if the count is three or more; FALSE otherwise. Devices marketed for depression without such an authorization, software-only products, and devices authorized only for in-clinic use do not count. If the FDA databases and sponsor announcements cannot establish the count 12 months after the deadline, the event is unresolvable.

FDA 510(k), De Novo and PMA databases (authorizations) with sponsor press releases (commercial availability)

TRUE on the date of the second definitive public announcement after the statement date that a distinct pandemic-era mental-health company is ceasing operations: a company statement or press release, an SEC filing, a Chapter 7 or dissolution filing, or a closure notice to patients or customers. 'Pandemic-era mental-health company' = a company whose main business is mental-health care or software (telehealth psychiatry or therapy, apps, clinics, benefits platforms), founded or launched in that business between March 2020 and December 2022. A layoff, a pivot, an acquisition that keeps the service running, a Chapter 11 filing with continued operations, or a rumor does not count. FALSE at the deadline when fewer than two such shutdowns have been announced by then. Resolution source: company press releases and statements; SEC EDGAR and bankruptcy dockets as secondary sources.

Company press releases and public statements; SEC EDGAR filings and bankruptcy dockets as secondary sources

TRUE on the effective date of a published medical policy or coverage bulletin from a US health plan (commercial or public), other than UnitedHealth Group/UnitedHealthcare and Cigna, that newly lists transcranial magnetic stimulation as covered or medically necessary for major depressive disorder in adolescents (an age range that includes patients under 18), where the plan's policy in force on 2026-01-05 did not cover TMS for patients under 18, as shown by the policy's revision history or the prior policy text. Adult-only TMS coverage, individual case exceptions and coverage limited to clinical trials do not count. FALSE at the deadline when no such policy has taken effect by then. Resolution source: the health plan's published medical policy bulletin (policy library with revision history).

The health plan's published medical policy bulletin (policy library with revision history)

TRUE on the date of the FDA's first action on Compass Pathways' new drug application for COMP360 (psilocybin) in treatment-resistant depression, in either direction: the approval letter as dated in Drugs@FDA (or in Compass Pathways' approval announcement), or a complete response letter as dated in Compass Pathways' announcement of it. The event is about the FDA reaching its decision, not the direction. A filing acceptance, a PDUFA goal date, an advisory committee vote, a review extension, a refuse-to-file letter or withdrawal of the application is not an action; if the application is never submitted, no action occurs. FALSE at the deadline when neither an approval in Drugs@FDA nor an announced complete response letter is dated by then. Resolution source: Drugs@FDA for an approval; Compass Pathways' press release for a complete response letter.

Drugs@FDA (approval); Compass Pathways press release for a complete response letter

TRUE on the date of the first public report of the Kale Award trial's primary outcome result: the peer-reviewed primary results publication, the investigators' topline release, or a results posting in the trial's registry entry, whichever is first. The result may favour bilateral, unilateral or neither; the event is about a primary result being reported. A protocol publication, a recruitment update, an interim safety report or a conference abstract without the primary outcome estimate does not count. FALSE at the deadline when no such report is dated by then. Resolution source: the peer-reviewed primary results publication (PubMed), with the trial registry entry as the secondary source.

Kale Award trial primary results publication (PubMed); trial registry entry as secondary source

TRUE on the publication date, in the Federal Register or on the FDA or DEA site, of a final rule, final guidance, order, scheduling action or operational program from the FDA or the DEA under which a patient in the United States may lawfully receive ibogaine treatment outside a registered clinical trial (for example a Right to Try pathway as directed by the 18 April 2026 executive order). A proposed rule, draft guidance, request for comment, statement of intent or the executive order itself is not the pathway. A state law or a foreign program does not count. FALSE at the deadline when no such final action has been published by then. Resolution source: the Federal Register (FDA and DEA documents), with FDA and DEA announcements as secondary sources.

Federal Register (FDA and DEA documents); FDA and DEA announcements as secondary sources

TRUE on the decision date in the FDA 510(k), De Novo or PMA database of a marketing authorization for a transcranial magnetic stimulation device, from any sponsor, whose indications for use name attention-deficit/hyperactivity disorder (adult or pediatric). Any setting of use (clinic or home) counts, as the claim names none. A breakthrough device designation, an investigational device exemption, a trial result or a publication is not an authorization. Off-label use and clinical guidelines do not count. FALSE at the deadline when no such authorization decision is dated in the FDA databases by then. Resolution source: the FDA 510(k), De Novo and PMA databases.

FDA 510(k), De Novo and PMA databases

TRUE on the date of the first FDA approval letter in Drugs@FDA for a drug product whose active ingredient is psilocybin, LSD (lysergide, any salt) or MDMA (midomafetamine, any salt), for any indication and from any sponsor. A complete response letter, a positive advisory vote or a filing acceptance is not an approval. FALSE at the deadline when no approval letter for such a product is dated in Drugs@FDA by then. Resolution source: Drugs@FDA.

Drugs@FDA

Resolved on Drugs@FDA (approval letters and approved labeling) read with the FDA REMS database (REMS@FDA). For each drug product whose active ingredient is psilocybin, LSD (lysergide, any salt) or MDMA (midomafetamine, any salt) that the FDA approves between the statement date and the deadline, check the approved labeling and any REMS in force on the approval date. TRUE on the approval date of the first such product whose labeling or REMS permits a retail or community pharmacy to dispense it to the patient or caregiver for use outside a healthcare setting. FALSE at the deadline if at least one such product has been approved and every such approval restricts dispensing to certified healthcare settings or requires administration under healthcare-provider supervision in a healthcare setting. If no such product is approved in the window, the condition is unmet and the item is void.

Drugs@FDA (approval letters and labeling) with the FDA REMS database (REMS@FDA)

Resolved on Drugs@FDA (approval letters and labeling) read with REMS@FDA. A novel psychedelic drug product is the first FDA-approved product with a psychedelic or entactogen active ingredient (the class the forecaster illustrates with psilocybin, LSD and MDMA); ketamine and esketamine products and new formulations of approved drugs do not count. TRUE on the approval date of the first such product, approved after the statement date, whose labeling and REMS require no monitoring of the patient by a healthcare provider during or after dosing (no observation period, no certified-setting dosing requirement). FALSE at the deadline if at least one such product has been approved and every one requires in-clinic monitoring during or after dosing. If none is approved in the window, the condition is unmet and the item is void.

Drugs@FDA (approval letters and labeling) with the FDA REMS database (REMS@FDA)

Resolved on Drugs@FDA (approval letters and labeling) read with REMS@FDA. A novel psychedelic drug product is the first FDA-approved product with a psychedelic or entactogen active ingredient (the class the forecaster illustrates with psilocybin, LSD and MDMA); ketamine and esketamine do not count. TRUE on the approval date of the first such product, approved after the statement date, whose labeling or REMS (including elements to assure safe use) requires video recording of dosing sessions, or a video record of each session kept or available for audit. Observation without recording, a non-binding recommendation, or a sponsor's voluntary program outside the labeling or REMS does not count. FALSE at the deadline if at least one such product has been approved and none carries such a requirement. If none is approved in the window, the condition is unmet and the item is void.

Drugs@FDA (approval letters and labeling) with the FDA REMS database (REMS@FDA)

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a botanical whole-plant or smoked marijuana drug product with a post-traumatic stress disorder indication is dated, under any sponsor name. Approval of a purified or synthetic cannabinoid (for example dronabinol, nabilone or a purified cannabidiol product) does not count. A complete response letter, a positive advisory vote or an IND clearance is not an approval. A label narrower than PTSD counts if the claim's indication reasonably includes it and the reading is logged at intake. Resolution source: Drugs@FDA. FALSE at the deadline when no such approval appears there.

Drugs@FDA

TRUE on the effective date of the first published coverage policy, medical policy bulletin, formulary listing or fee schedule of a US health insurer, Medicare or a state Medicaid program that covers an FDA-approved botanical (whole-plant or smoked) marijuana product for the indication named on its FDA-approved label. Coverage of cannabinoid drugs that are not botanical marijuana (for example dronabinol, nabilone or a purified cannabidiol product) does not count. Reimbursement under a state medical-marijuana program without FDA approval does not count. Resolution source: the payer's published policy bulletin, with the CMS Medicare Coverage Database for Medicare and Medicaid policies. FALSE at the deadline when no such policy is in effect.

Payer policy bulletins (commercial insurers, state Medicaid); CMS Medicare Coverage Database

TRUE on the date the DEA issues a Schedule I bulk manufacturer registration to Prof. Lyle Craker, or to the University of Massachusetts Amherst facility he directs, for the manufacture of marijuana for research, as published in the Federal Register or announced by the DEA Diversion Control Division. A DEA policy statement that it will accept applications, an acceptance of an application for filing, or a court or administration order directing the DEA to act is not a registration. Resolution source: the Federal Register DEA registration notices. FALSE at the deadline when no such registration has been issued.

Federal Register (DEA registration notices); DEA Diversion Control Division announcements

TRUE on the date of an FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, whose approval letter or REMS@FDA entry shows a REMS in force at approval: any REMS with elements to assure safe use, or other elements that restrict who may prescribe, dispense or administer the drug, or where it is given. FALSE on the date of an approval with no REMS. A REMS added after approval does not count. The event is unresolved while no approval exists. Resolution source: Drugs@FDA (approval letter) read with REMS@FDA.

Drugs@FDA (approval letter) with REMS@FDA

TRUE on the date of an FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, whose approved labeling or REMS document requires that the therapists or healthcare providers who administer the drug or conduct dosing sessions complete a training or certification program provided or certified by the sponsor (MAPS, MAPS PBC or a successor), with no other route to eligibility. FALSE on the date of an approval whose labeling and REMS permit administration by providers without sponsor-provided training, name the sponsor's program as one acceptable route among others, or set no provider training requirement. The event is unresolved while no approval exists. Resolution source: Drugs@FDA (approved labeling) read with REMS@FDA.

Drugs@FDA (approved labeling) with REMS@FDA

TRUE on the date of an FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, whose approved labeling or REMS document requires that each dose is administered in a certified healthcare setting under the supervision of a healthcare provider, and does not permit dispensing the drug to the patient for use outside that setting. FALSE on the date of an approval whose labeling or REMS permits a pharmacy to dispense the product to the patient for use outside a healthcare setting, or permits unsupervised use. The event is unresolved while no approval exists. Resolution source: Drugs@FDA (approved labeling) read with REMS@FDA.

Drugs@FDA (approved labeling) with REMS@FDA

TRUE on the date of a Health Canada Notice of Compliance (with or without conditions) for a midomafetamine (MDMA) drug product with an indication of post-traumatic stress disorder, as recorded in the Notice of Compliance database or the Drug Product Database; any sponsor name counts. A Special Access Program authorization, a clinical trial authorization, or a Notice of Deficiency or Non-compliance is not an approval. A label narrower than PTSD counts if the claim's indication reasonably includes it and the reading is logged at intake. Resolution source: Health Canada Notice of Compliance database, with the sponsor's press release as a secondary source. FALSE at the deadline when that database lists no such Notice of Compliance.

Health Canada Notice of Compliance database; sponsor press release as a secondary source

TRUE on the date the Israel Ministry of Health registers a midomafetamine (MDMA) drug product with an indication of post-traumatic stress disorder in its drug registry, under any sponsor name, or the date the sponsor announces that registration. A compassionate-use or named-patient permit, an expanded-access programme, or a clinical trial authorization is not an approval. A label narrower than PTSD counts if the claim's indication reasonably includes it and the reading is logged at intake. Resolution source: the Israel Ministry of Health drug registry, with the sponsor's press release as a secondary source. FALSE at the deadline when no such registration appears there.

Israel Ministry of Health drug registry (Israel Drug Registry); sponsor press release as a secondary source

TRUE on the date MAPS, MAPS Public Benefit Corporation or its successor first states publicly that the FDA has agreed to all three proposals named in the claim: the protocol under which therapists receive MDMA themselves, the Expanded Access program for MDMA-assisted therapy for PTSD, and the co-therapist credential requirements. All three must be reported as accepted; acceptance of one or two does not resolve TRUE. A submitted proposal, a scheduled or held FDA meeting, a pending request or an FDA comment short of agreement is not acceptance. Resolution source: MAPS announcements (press releases and the MAPS Bulletin). FALSE at the deadline when MAPS has not reported all three as accepted.

MAPS (MAPS Public Benefit Corporation) press releases and MAPS Bulletin announcements

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) is dated for a midomafetamine (MDMA) drug product, under any sponsor name, whose approved labeling names an indication other than post-traumatic stress disorder (for example an eating disorder, social anxiety or a substance use disorder). An approval for PTSD alone, a PTSD subgroup, a complete response letter, a positive advisory vote, a breakthrough designation or a filing acceptance is not an approval for another indication. Resolution source: Drugs@FDA. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA

TRUE on the date of the FDA approval letter or Drugs@FDA entry for a new drug application, 505(b)(2) application or abbreviated new drug application for a product whose active ingredient is MDMA (midomafetamine, any salt or enantiomer mix marketed as MDMA), for any indication, whose applicant is not MAPS Public Benefit Corporation, its successor under any name, or a company that markets the MAPS PBC product under license. A tentative approval, a complete response letter, an IND, a breakthrough designation or a filing acceptance is not an approval. Resolution source: Drugs@FDA (application holder and approval date). FALSE at the deadline when Drugs@FDA lists no such approval.

Drugs@FDA (approval letters and application holders)

TRUE on the effective date of a Texas Register notice or a Texas Department of State Health Services schedule action that removes MDMA (midomafetamine) or an FDA-approved MDMA drug product from Schedule I of the Texas Schedules of Controlled Substances, or places it in Schedule II, III, IV or V. A schedule change that takes effect through the Commissioner of Health's non-objection to a federal rescheduling counts the same as any other schedule action. A federal DEA rescheduling alone, a proposal or a legislative bill does not resolve the event. Resolution source: the Texas Register (Texas Secretary of State) and the DSHS Texas Schedules of Controlled Substances page. FALSE at the deadline when no such Texas schedule action has taken effect.

Texas Register (Texas Secretary of State) and the Texas Department of State Health Services schedules of controlled substances

Resolved on the named data series only: the count of US sites certified to administer an FDA-approved psychedelic-assisted therapy (an MDMA or psilocybin drug product) under that product's REMS, per the REMS program's published certified-site list, summed across approved products with duplicate sites counted once. 'About 5,000 or 6,000' is a point estimate of 5,500 and takes the template's fixed band of plus or minus 20 percent: TRUE when the count at the deadline is 4,400 to 6,600, FALSE otherwise. If no such list has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored. Resolution source: the REMS certified-site lists in REMS@FDA.

REMS certified-site lists of FDA-approved psychedelic-assisted therapy products (FDA REMS@FDA database and the REMS program websites)

TRUE on the publication date in the Federal Register of a DEA final rule (or interim final rule) that places midomafetamine (MDMA), or an FDA-approved midomafetamine drug product, in Schedule II, III, IV or V, or removes it from control. A proposed rule, a scheduling recommendation from HHS or FDA, a state law, or a rescheduling of another substance does not count. Resolution source: the Federal Register. FALSE at the deadline when no such rule is published there.

Federal Register

TRUE on the publication date in the Federal Register of the DEA final rule (or interim final rule) that reschedules midomafetamine (MDMA), or an FDA-approved midomafetamine drug product, when that rule places it in Schedule III or Schedule IV. FALSE on the publication date of a rescheduling rule that places it in Schedule II or Schedule V, and FALSE at the deadline when no rescheduling rule has been published. A proposed rule or an HHS/FDA scheduling recommendation does not count. Resolution source: the Federal Register.

Federal Register

Resolved on the named data series only: the cumulative count of people treated with midomafetamine (MDMA-assisted therapy) for PTSD, as published by MAPS or by the sponsor of the midomafetamine programme (annual report, press release or investor materials), with a named prescription-data series (for example IQVIA) as the secondary count when the sponsor publishes none. TRUE on the date of the first such publication that reports a cumulative total at or above 1.12 million people, the lower edge of the fixed band of plus or minus 20 percent around the bare point number of about 1.4 million. Patients dosed in clinical trials count. FALSE at the deadline when no publication reports a total in or above that band. If no count has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

MAPS and sponsor public counts of people treated with MDMA-assisted therapy; a named prescription-data series (IQVIA) as the secondary count

TRUE on the date the FDA approval letter or the Drugs@FDA entry for an ibogaine drug product with a substance use disorder indication (for example opioid, alcohol, stimulant or polysubstance use disorder) is dated, under any sponsor and with or without patents. A label for one substance use disorder counts, because the claim names the class. A complete response letter, a positive advisory vote, a filing acceptance, a breakthrough designation or an expanded-access programme is not an approval, and approval of a different molecule (for example noribogaine or another ibogaine analogue) does not count. FALSE at the deadline when no such approval is dated. Resolution source: Drugs@FDA, with the sponsor's approval announcement as a secondary source.

Drugs@FDA; sponsor approval announcement as a secondary source

TRUE on the date of a definitive public announcement by MAPS (press release, annual report or MAPS Bulletin), or by the entity that runs the MAPS ibogaine research programme for substance use disorders, that the programme is fully funded by government money or by donations for the work needed to reach an FDA decision. A single grant, a donation, a fundraising target or a pledge that MAPS does not state covers the whole programme does not count, and funding raised by a for-profit sponsor as equity does not count. FALSE at the deadline when no such announcement exists. Resolution source: MAPS press releases and the MAPS Bulletin.

MAPS press releases and MAPS Bulletin

Resolved on the named data series only: Johnson & Johnson's public disclosures (annual report, earnings materials, investor presentations or press releases) of the number of patients treated with Spravato (esketamine) per year or in a stated 12-month period. TRUE on the date of the first such disclosure, dated between the statement date and the window end, that reports 200,000 or more patients treated with Spravato in a 12-month period (worldwide if J&J reports worldwide; US if J&J reports only US). The threshold is in the forecaster's words ('hundreds of thousands', read at its lower bound), so it resolves as binary at 200,000 with no band. FALSE at the window end when no such disclosure reports 200,000 or more. If Johnson & Johnson has published no patient count 12 months after the window end, the event is unresolvable. Realized values are stored, not scored.

Johnson & Johnson public disclosures of Spravato patients treated (annual report, earnings materials, investor presentations, press releases)

TRUE on the date of the first public report of topline results of the Phase 2 trial of VLS-01 (buccal film DMT) in treatment-resistant depression: atai Life Sciences' topline press release, the ClinicalTrials.gov results posting, or the publication that first reports the result. The direction of the result does not matter; the event is the readout. Enrolment or dosing news, an interim or blinded update, a safety update, open-label data from another VLS-01 study, and a conference abstract without the primary-endpoint result do not count. FALSE at the deadline when no topline result has been reported. Resolution source: atai Life Sciences' topline press release, with the ClinicalTrials.gov record of the trial fixing the date if the sponsor publishes none.

atai Life Sciences topline press release; ClinicalTrials.gov record of the VLS-01 Phase 2 trial in treatment-resistant depression

TRUE on the date the sponsor of the midomafetamine (MDMA-assisted therapy) NDA for PTSD publicly announces, or the FDA publishes, that the FDA has agreed the application can be resubmitted or reviewed without an additional Phase 3 trial (a Phase 4 or other post-approval requirement does not defeat the condition). FALSE when the FDA requires an additional Phase 3 trial before resubmission or approval, per the sponsor's announcement or the FDA's published correspondence, and FALSE at the deadline when no such agreement has been announced.

Sponsor press release; FDA published correspondence (Drugs@FDA)

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) is dated for a psychedelic drug product (midomafetamine, psilocybin, LSD, ibogaine or another psychedelic or entactogen) whose approved prescribing information or REMS permits administration of the drug in a session with more than one patient present as a treated group. An approval whose labeling requires individual (one-patient) dosing sessions, a complete response letter, a designation or a filing acceptance does not count. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA

TRUE on the date of the last of four sponsor topline press releases (atai Life Sciences or its successor, Beckley Psytech or Recognify Life Sciences), ClinicalTrials.gov results postings or peer-reviewed publications that each report the prespecified primary endpoint met with statistical significance, as reported by the sponsor, for the four trials named in the asset: BPL-003 Phase 2b in treatment-resistant depression, RL-007 Phase 2b in cognitive impairment associated with schizophrenia, VLS-01 Phase 2 in treatment-resistant depression and EMP-01 Phase 2a in social anxiety disorder. FALSE on the date the sponsor first reports that any one of the four did not meet its primary endpoint, and FALSE at the window end if any of the four has not reported a primary endpoint result. Open-label, interim and pooled analyses do not count.

atai Life Sciences (or successor company) topline press releases; ClinicalTrials.gov results as a secondary source

Resolved on the named data series only: the IQVIA Institute's global medicine spending by therapeutic area (Global Use of Medicines report). TRUE for the first reporting year in which the series ranks the mental health therapeutic area first by global spending, above oncology, cardiovascular and every other area. The rank is read from the series as published; when the series publishes no separate mental health line, its nearest mental health category is used and the reading is logged at intake. FALSE at the deadline when no published year ranks mental health first. If the series has not published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

IQVIA Institute, Global Use of Medicines (spending by therapeutic area)

Resolved on the named data series only: worldwide net product sales of BPL-003 (intranasal 5-MeO-DMT, mebufotenin) reported by its sponsor, licensee or successor in audited annual financial statements filed with the SEC. TRUE for the first reported financial year in which those net sales are at or above US$1,000,000,000. The threshold is the blockbuster number the word 'blockbuster' names, so it resolves as binary at US$1 billion with no band. Milestone payments, upfront licence fees, collaboration revenue and non-BPL-003 product sales do not count. FALSE at the deadline when no reported year reaches the threshold. If no such sales figure has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

Sponsor annual report filed with the SEC (EDGAR); sponsor results press release as a secondary source

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a new drug application for BPL-003 (intranasal 5-MeO-DMT, mebufotenin), for any indication and under any sponsor name, is dated, when the approval letter, the FDA clinical review or the approved labeling (clinical studies section) lists exactly one adequate and well-controlled Phase 3 efficacy trial as the basis of efficacy; Phase 2 trials, open-label extensions and safety studies are not Phase 3 efficacy trials. An approval whose efficacy basis lists two or more Phase 3 efficacy trials resolves FALSE. A complete response letter, an FDA meeting agreement on a single-trial path, a designation or a filing acceptance is not an approval. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA (approval letter, review documents and labeling); sponsor press release as a secondary source

TRUE on the date atai Life Sciences' topline press release, the ClinicalTrials.gov results posting, or the first publication reports that the Phase 2 trial of VLS-01 (buccal film DMT) in treatment-resistant depression met its prespecified primary endpoint with statistical significance, as reported by the sponsor at the trial's prespecified alpha. FALSE on the date the sponsor first reports that the primary endpoint was not met, and FALSE at the deadline when no primary-endpoint result has been reported. Secondary endpoints, subgroup analyses, interim analyses and open-label data do not count. Resolution source: atai Life Sciences' topline press release, with the ClinicalTrials.gov record of the trial as the secondary source.

atai Life Sciences topline press release; ClinicalTrials.gov record of the VLS-01 Phase 2 trial in treatment-resistant depression

TRUE on the publication date, in the guideline body's own published guideline document, of a clinical practice guideline for a psychiatric disorder that lists a psychedelic medicine (for example psilocybin, MDMA, LSD or 5-MeO-DMT) as a first-line treatment option for that disorder. A major guideline body is the American Psychiatric Association, NICE, the VA/DoD, the WFSBP or CANMAT. A draft, a proposal or a public-comment version is not adoption. A guideline that names the medicine only for treatment-resistant, second-line, adjunctive or last-resort use does not count. FALSE at the deadline when no such guideline is published.

The published clinical practice guideline of the guideline body (American Psychiatric Association, NICE, VA/DoD, WFSBP or CANMAT)

Resolved on the named data series only: the market capitalization of atai Life Sciences (Nasdaq: ATAI, or its successor listing), computed as the Nasdaq closing share price multiplied by the shares outstanding stated on the cover page of atai's most recent periodic SEC filing on EDGAR. TRUE on the first trading day on which that closing market capitalization is at or above US$20 billion. The threshold is in the forecaster's words, so it resolves as binary at US$20 billion with no band. FALSE at the deadline when no market close has reached US$20 billion. If the shares stop trading with no successor listing and no price series has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

Nasdaq closing price for ATAI and shares outstanding in atai Life Sciences periodic filings on SEC EDGAR

Resolved on the named data series only: the market capitalization of atai Life Sciences (Nasdaq: ATAI, or its successor listing), computed as the Nasdaq closing share price multiplied by the shares outstanding stated on the cover page of atai's most recent periodic SEC filing on EDGAR. TRUE on the first trading day on which that closing market capitalization is at or above US$50 billion. The threshold is in the forecaster's words, so it resolves as binary at US$50 billion with no band. FALSE at the deadline when no market close has reached US$50 billion. If the shares stop trading with no successor listing and no price series has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

Nasdaq closing price for ATAI and shares outstanding in atai Life Sciences periodic filings on SEC EDGAR

TRUE on the date of the sponsor's public announcement (press release or SEC filing) that the new drug application for COMP360 (synthetic psilocybin) in treatment-resistant depression has been submitted to the FDA. For a rolling submission, the date the sponsor announces completion of the submission counts. An FDA filing acceptance is not required and is not itself a submission. The sponsor is Compass Pathways under any corporate name or a successor, because the entry is on the asset. FALSE at the deadline when no such announcement exists.

Compass Pathways press releases; SEC EDGAR filings

TRUE on the effective date of a published medical or coverage policy, fee schedule entry, NCD or LCD, or public policy bulletin from a US health insurer, health plan or government program (Medicare, Medicaid, VA or a commercial plan) that covers midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder and pays for both the drug and the therapy sessions delivered with it. A policy that covers the drug alone, a pilot announcement without a policy, or coverage of unapproved use does not count. FALSE at the deadline when no such policy has been published.

Payer policy bulletins; CMS Medicare Coverage Database

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) is dated for a drug product whose active ingredient is midomafetamine (MDMA) or psilocybin, for any indication. A complete response letter, a positive advisory vote, a designation or a filing acceptance is not an approval. An LSD approval alone does not satisfy the condition (unlike E-0066). FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA

TRUE on the date of the Ministry of Health of Ukraine order, or the entry in the State Register of Medicinal Products of Ukraine, that registers a medicinal product whose active ingredient is midomafetamine (MDMA) or psilocybin for any indication (or the sponsor's announcement of that registration). A clinical trial authorisation, an import permit for a trial, a compassionate-use or named-patient permission, or an approval in another country does not count. FALSE at the deadline when no such registration exists.

State Register of Medicinal Products of Ukraine (Ministry of Health of Ukraine); sponsor press release

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a new drug application for BPL-003 (intranasal 5-MeO-DMT, mebufotenin), for any indication and under any sponsor name, is dated. A complete response letter, a breakthrough therapy designation, a positive advisory vote or a filing acceptance is not an approval. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA; sponsor press release as a secondary source

TRUE on the date the FDA approval letter or Drugs@FDA entry (or the sponsor's approval announcement) for a new drug application for DT120 (MM120, lysergide D-tartrate), for any indication and under any sponsor name, is dated. A complete response letter, a breakthrough therapy designation, a positive advisory vote or a filing acceptance is not an approval. FALSE at the deadline when no such approval appears in Drugs@FDA.

Drugs@FDA; sponsor press release as a secondary source

TRUE on the earlier of (1) the date the sponsor (Resilient Pharmaceuticals, formerly Lykos Therapeutics, or a successor) announces that the FDA has accepted a resubmission of the midomafetamine (MDMA-assisted therapy) NDA for PTSD for review, with or without a stated goal date, or the FDA publishes that acceptance, and (2) the date of an FDA action letter (approval or complete response) on that resubmission, as dated in Drugs@FDA or the sponsor's announcement. A report that the sponsor resubmitted, a meeting, or FDA correspondence that refuses to file the resubmission does not count. FALSE at the deadline when neither has occurred.

Sponsor press release; Drugs@FDA

Resolved on the named data series only: annual US prescription counts in the IQVIA National Prescription Audit. TRUE for the first calendar year in which that series reports prescriptions dispensed for approved psilocybin drug products at or above prescriptions dispensed for classic antidepressants (SSRIs, SNRIs, tricyclics and MAOIs) in the same year and the same series. The threshold is a comparison of the two counts, so it resolves as binary at a ratio of 1, with no band. A year with no dispensed psilocybin prescriptions resolves FALSE for that year. FALSE at the deadline when no published year meets the comparison. If the series has not published the figures for the deadline year 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

IQVIA National Prescription Audit, annual US prescription counts by product class

TRUE on the date of the sponsor's topline press release, or the publication, that first reports a Phase 3 trial of a psychedelic therapeutic developed, owned or partnered by atai Life Sciences (or its subsidiary, successor or partner) with its prespecified primary endpoint met with statistical significance, as reported by the sponsor. A psychedelic therapeutic is a compound its sponsor or the regulator describes as a psychedelic or an entactogen; esketamine and ketamine are excluded. A Phase 2 result, an open-label result, an interim analysis or a secondary endpoint is not a Phase 3 primary result. Resolution source: the sponsor's topline press release, with ClinicalTrials.gov results as a secondary source. FALSE at the deadline when no such Phase 3 result has been reported.

Sponsor topline press release; ClinicalTrials.gov results as a secondary source

TRUE on the decision date, in the FDA 510(k), De Novo or PMA database, of a marketing authorization dated after 2026-03-23 for a transcranial magnetic stimulation device whose indications-for-use statement names a psychotic disorder or a symptom of psychosis (for example schizophrenia, schizoaffective disorder, auditory hallucinations or auditory verbal hallucinations). A breakthrough device designation, a published trial, a professional-society guideline and off-label clinical use are not an authorization. Resolution source: the FDA device databases (510(k), De Novo, PMA). FALSE at the deadline when no such authorization is listed.

FDA 510(k), De Novo and PMA databases

TRUE on the Federal Register publication date of a DEA final rule that sets a permanent framework for the prescribing of controlled substances by telemedicine without a prior in-person medical evaluation. A proposed rule, a temporary rule, and an extension of the COVID-era telemedicine flexibilities are not adoption. FALSE at the deadline when no such final rule has been published in the Federal Register. Resolution source: the Federal Register (DEA final rules).

Federal Register (DEA final rules)

TRUE on the effective date of a published medical or coverage policy, fee schedule entry, national coverage determination, local coverage determination or public policy bulletin from a US health insurer, health plan or public program (a commercial plan, Medicare, Medicaid or the VA) that lists intravenous ketamine as covered or medically necessary for bipolar depression. A policy that covers esketamine (Spravato), a policy limited to major depressive disorder, an individual case exception, coverage limited to a clinical trial, and a payment for the infusion visit without the drug do not count. FALSE at the deadline when no such policy is in force. Resolved on the payer's published policy bulletin and the CMS Medicare Coverage Database.

Payer medical policy bulletins; CMS Medicare Coverage Database

TRUE on the effective date of a published coverage policy, bulletin, fee schedule, national coverage determination or local coverage determination of a US health insurer or US public health program (Medicare, Medicaid, the Veterans Health Administration or a commercial plan) that pays for a psychedelic medicine, meaning a drug product whose active ingredient is a classic psychedelic (for example psilocybin, LSD or ibogaine) or MDMA, or for the administration of such a product. A pilot grant, a research grant, a cash-pay price list and a single negotiated case are not coverage. FALSE at the deadline when no such policy has taken effect. Resolution source: the CMS Medicare Coverage Database and the published policy bulletins of the paying insurer or program.

CMS Medicare Coverage Database; published payer policy bulletins of the paying insurer or program

TRUE on the date of the first marketing authorisation, registration or approval decision by a national or regional medicines regulator outside the United States (for example the European Commission on a CHMP positive opinion, the MHRA, Health Canada, the TGA or the Israel Ministry of Health) for a midomafetamine (MDMA) product for post-traumatic stress disorder, under any sponsor name. A special access, compassionate use, authorised prescriber or named-patient scheme, a designation, a rescheduling and a filing acceptance are not approvals. FALSE at the deadline when no such approval has been granted. Resolution source: the approving regulator's own medicines database or decision notice, with the sponsor's press release as a secondary source.

The approving regulator's medicines database (EMA EPAR, MHRA, Health Canada Drug Product Database, TGA ARTG, Israel Ministry of Health); sponsor press release as a secondary source

TRUE on the effective date of the first federal or state law, regulation or licensed programme in the United States, as published in the Federal Register, a state register or the text of the enacted bill, under which an adult who holds a licence, permit or certificate may lawfully purchase a psychedelic drug (for example psilocybin, MDMA or LSD) and take it on their own, outside medical or facilitator supervision. A programme that requires the dose to be taken under supervision at a licensed service centre, a medical prescription route, a decriminalisation measure that removes penalties without creating a licence to purchase, and a bill that has not taken effect, do not count. FALSE at the deadline when no such law, regulation or programme has taken effect. Resolution source: the Federal Register and state legislature records.

Federal Register; state registers and enacted state legislation (state legislature records)

Resolved on the named data series only: the count of European sites certified or registered to administer an approved psychedelic-assisted therapy (an MDMA or psilocybin medicine), per the certified treatment-centre list published under that medicine's controlled-distribution or risk-management plan on the European Medicines Agency medicine page and by the marketing authorisation holder, summed across approved medicines with duplicate sites counted once. 'Another 6,000' is a bare point number and takes the template's fixed band of plus or minus 20 percent: TRUE when the count at the deadline is 4,800 to 7,200, FALSE otherwise. If no such list has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored.

Certified treatment-centre lists published under the controlled-distribution or risk-management plan of an EMA-approved psychedelic medicine (EMA medicine page and marketing authorisation holder site)

Resolved on the named data series only: the count of US sites certified to administer an FDA-approved psychedelic-assisted therapy (an MDMA or psilocybin drug product) under that product's REMS, per the REMS programme's published certified-site list, summed across approved products with a duplicate site counted once. 'Six or 7,000' is a point estimate of 6,500 and takes the template's fixed band of plus or minus 20 percent: TRUE when the count at the deadline is 5,200 to 7,800, FALSE otherwise. If no such list has published 12 months after the deadline, the event is unresolvable. Realized values are stored, not scored. Resolution source: the REMS certified-site lists in REMS@FDA.

REMS certified-site lists in REMS@FDA

Resolved on the named data series only: worldwide net trade sales of Spravato (esketamine nasal spray) in Johnson & Johnson's product-sales tables in its periodic reports on SEC EDGAR (Form 10-K and Form 10-Q) and the sales exhibits of its quarterly earnings releases (Form 8-K). TRUE on the date of the first Johnson & Johnson report that shows Spravato worldwide net sales at or above US$3 billion for calendar year 2026. 'Several billion revenues in 2026' is read at its lower bound, US$3 billion, the smallest count that is 'several' billion, so the event resolves as binary at US$3 billion with no band. FALSE at the deadline when the reported calendar-2026 figure is below US$3 billion. Unresolvable if no calendar-2026 figure has published 12 months after the deadline. Realized values are stored, not scored.

Johnson & Johnson product sales tables in its Form 10-K, Form 10-Q and earnings-release sales exhibits on SEC EDGAR