Intelligence

Behavioral Health Intelligence Dashboard

Regulation, markets, pipeline status, and news signals across pharma, psychedelics, cannabis, and digital health — monitored from public sources and reviewed with editorial judgment.

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Regulatory tracker

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Recent public filings and regulatory signals from monitored government sources.

September 23, 2026
FDA
Sanjay Kumar: Final Debarment Order
scheduling

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sanjay Kumar for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a findi

View on Federal Register
DEA
Schedules of Controlled Substances: Placement of 4-Hydroxy-N,N-Diisopropyltryptamine (4-OH-DiPT), 5-Methoxy-alpha-Methyltryptamine (5-MeO-AMT), 5-Methoxy-N-Methyl-N-Isopropyltryptamine (5-MeO-MiPT), 5-Methoxy-N,N-Diethyltryptamine (5-MeO-DET), and N,N-Diisopropyltryptamine (DiPT) Into Schedule I
scheduling

The Drug Enforcement Administration proposes placing five tryptamine hallucinogens, 4-hydroxy-N,N-diisopropyltryptamine (other names: 4-OH-DiPT; 3-(2-(diisopropylamino)ethyl)-1H-indol-4- ol), 5-methoxy-alpha-methyltryptamine (other names: 5-MeO-AMT; 1-(5- methoxy-1H-indol-3-yl)pr

View on Federal Register
CT
Effect of Stellate Ganglion Block on Sleep Quality in Patients With Depression
research

Sleep and Circadian Problems — Stellate Ganglion Block

View on ClinicalTrials.gov
CT
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
research

Perinatal Mental Health, Gestational Weight Gain, Postpartum Weight Retention, Child Development — HAP3 Family App

View on ClinicalTrials.gov
CT
Psychoeducation for Anxiety, Depression, Cognitive Avoidance, and Sense of Coherence in Women With Cancer
research

Cancer — Structured Psychoeducational Intervention

View on ClinicalTrials.gov
CT
Psychological Resilience and Quality of Life Among Caregivers of Patients With Schizophrenia
research

Schizophrenia, Caregiver Burden, Quality of Life

View on ClinicalTrials.gov

Market movers

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Tracked equities connected to behavioral health: pharma psychiatry, psychedelics, cannabis, and digital health.

CURLF Curaleaf
Cannabis
$11.60 +1.15 (+11.00%)
Sep 23, 2026 21:15 UTC · Delayed quote
No historical price series is available for CURLF from the current data provider. Last-price and change data below remain from the delayed quote snapshot.
Last
$11.60
Change
+1.15
Change %
+11.00%

Delayed quotes. Last updated 23 Sep 2026, 21:15 UTC.

Movers

Markets →
Gainers
Losers

Delayed quotes. Last updated 23 Sep 2026, 21:15 UTC.

News wire

DIGITAL
Pelago launched an AI-routed behavioral health platform with economic evidence for its old substance-use model, but no evidence the AI's own care-routing decisions are accurate
PHARMA
Vistagen's fasedienol improved for four months in an uncontrolled extension study, nearly three months after its placebo-controlled PALISADE-4 trial missed, a second consecutive Phase 3 miss
REGULATION
FDA's psychedelic hearing surfaced an unresolved provider-qualification fight, with no signal of the agency's own preference across the twenty speakers examined
PSYCHEDELICS
MycoMedica registered the first psilocybin trial in PMDD on ClinicalTrials.gov, a Phase 1b testing six low doses across one menstrual cycle with no psychotherapy component
MARKETS
Lilly completed its AtaiBeckley acquisition; $2.8 billion was fixed at closing, $1 billion remains contingent

Pipeline tracker

Last updated Sep 22, 2026

Selected programs Behavioral Wire tracks across behavioral health markets. Sortable by column; filter by desk or stage.

Programs tracked
29
Across 4 desks
Phase 3
15
Pivotal stage
Phase 2 / 1
6
Earlier stage
Filed
0
Awaiting action
Approved
8
Marketed or cleared
Desk Stage
Program Sponsor Desk Phase Status Updated
Zuranolone (Zurzuvae)Postpartum depression Supernus (Biogen collaboration) Pharma Approved Marketed for PPD; MDD rejected 2026-04-18
AXS-05 (Auvelity)Major depressive disorder Axsome Therapeutics Pharma Approved Marketed 2026-05-09
Esketamine (Spravato)Treatment-resistant depression Johnson & Johnson Pharma Approved Monotherapy label cleared 2026-02-27
Cobenfy (xanomeline-trospium)Schizophrenia Bristol Myers Squibb Pharma Approved ARISE adjunctive missed; Alzheimer's trials ongoing 2026-05-15
Centanafadine (SIMTRIYO)ADHD (adults and children 6+, at least 20 kg) Otsuka Pharma Approved FDA-approved July 2026 (first-in-class NDSRI); DEA scheduling pending before launch 2026-07-24
Navacaprant (NMRA-140)Major depressive disorder Neumora Therapeutics Pharma Phase 3 KOASTAL-2/-3 missed; development discontinued 2026-06-15
EmraclidineSchizophrenia AbbVie (Cerevel) Pharma Phase 2 Phase 2 failed; program written down 2026-01-22
NBI-1117568 (M4 agonist)Schizophrenia Neurocrine Biosciences Pharma Phase 3 Phase 3 program recruiting (three registration studies plus relapse-prevention); Phase 2 in bipolar I mania 2025-12-24
Brenipatide (LY3537031)Major depressive disorder; alcohol use disorder Eli Lilly Pharma Phase 3 Phase 3 recruiting in MDD and alcohol use disorder; Phase 2 in bipolar I and schizophrenia 2026-02-10
SeltorexantMajor depressive disorder with insomnia symptoms Johnson & Johnson Pharma Phase 3 MDD3001 positive; MDD3005 vs quetiapine XR missed primary endpoint (Sept 2025); additional Phase 3 recruiting 2025-09-22
ACP-204Alzheimer's disease psychosis Acadia Pharmaceuticals Pharma Phase 2 Seamless Phase 2/3 in Alzheimer's disease psychosis recruiting; Phase 2 in Lewy body dementia psychosis 2025-08-06
FasedienolSocial anxiety disorder (acute treatment) Vistagen Therapeutics Pharma Phase 3 PALISADE-3 (Dec 2025) and PALISADE-4 (June 2026) both missed primary endpoint vs. placebo; new multi-dose Phase 3 planned pending FDA meeting 2026-09-22
COMP360 psilocybinTreatment-resistant depression Compass Pathways Psychedelics Phase 3 Phase 3 complete; rolling NDA underway 2026-07-08
DT120 (lysergide ODT)Major depressive disorder Definium Therapeutics (formerly MindMed) Psychedelics Phase 3 Phase 3 positive; second trial enrolling 2026-06-23
DT120 (lysergide ODT)Generalized anxiety disorder Definium Therapeutics (formerly MindMed) Psychedelics Phase 3 Both Phase 3s positive (Voyage, Panorama); NDA filing targeted H1 2027 2026-09-14
MDMA-assisted therapyPTSD Resilient Pharmaceuticals (formerly Lykos) Psychedelics Phase 3 Pivotal trials complete; regulatory path unresolved 2025-06-06
HLP003 (deuterated psilocin)Major depressive disorder Helus Pharma (formerly Cybin) Psychedelics Phase 3 Breakthrough designation; Phase 3 APPROACH topline expected 2H 2026 2026-07-02
GH001 (inhaled mebufotenin)Treatment-resistant depression GH Research Psychedelics Phase 2 Phase 2 positive 2026-03-05
BPL-003 (intranasal mebufotenin)Treatment-resistant depression Eli Lilly (formerly AtaiBeckley) Psychedelics Phase 3 Phase 3 initiated; Lilly acquisition closed Sept 11, 2026 2026-09-11
Luvesilocin (RE104)Postpartum depression Reunion Neuroscience Psychedelics Phase 2 Breakthrough designation; Phase 3 planned for 2026 2026-02-23
TSND-201 (methylone)PTSD Otsuka (formerly Transcend Therapeutics) Psychedelics Phase 3 Phase 3 underway; IMPACT-1 Phase 2 positive; acquired by Otsuka June 2026 2026-06-12
Usona psilocybin (uAspire)Major depressive disorder Usona Institute Psychedelics Phase 3 Phase 3 uAspire primary completion Jan 2026 per registry; results and filing pending 2026-01-05
VLS-01 (buccal DMT)Treatment-resistant depression Eli Lilly (formerly AtaiBeckley) Psychedelics Phase 2 Phase 2b Elumina dosing complete July 2026; topline expected Q4 2026; Phase 3 in MDD planned 2026-07-06
HLP004 (deuterated DMT)Generalized anxiety disorder Helus Pharma (formerly Cybin) Psychedelics Phase 2 Phase 2 signal-detection topline reported March 2026 (adjunct to standard of care) 2026-03-05
Epidiolex (cannabidiol)Epilepsy; behavioral indications explored Jazz Pharmaceuticals Cannabis Approved Additional indications under study 2026-02-14
Zygel (CBD transdermal gel)Fragile X syndrome Harmony Biosciences Cannabis Phase 3 RECONNECT readout; FXS program phased out 2026-02-24
RejoynMajor depressive disorder (adjunct) Otsuka / Click Therapeutics Digital Approved First FDA-cleared MDD app 2026-04-04
CT-155Schizophrenia (negative symptoms) Click Therapeutics (Boehringer Ingelheim) Digital Phase 3 CONVOKE Phase 3 positive; commercialization transferred to Click 2026-04-09
Sleepio / DaylightInsomnia and anxiety Big Health Digital Approved Marketed digital therapeutics 2026-01-12
Zuranolone (Zurzuvae) Pharma
Postpartum depression
Marketed for PPD; MDD rejected
Approved Updated 2026-04-18
AXS-05 (Auvelity) Pharma
Major depressive disorder
Marketed
Approved Updated 2026-05-09
Esketamine (Spravato) Pharma
Treatment-resistant depression
Monotherapy label cleared
Approved Updated 2026-02-27
Cobenfy (xanomeline-trospium) Pharma
Schizophrenia
ARISE adjunctive missed; Alzheimer's trials ongoing
Approved Updated 2026-05-15
Centanafadine (SIMTRIYO) Pharma
ADHD (adults and children 6+, at least 20 kg)
FDA-approved July 2026 (first-in-class NDSRI); DEA scheduling pending before launch
Approved Updated 2026-07-24
Navacaprant (NMRA-140) Pharma
Major depressive disorder
KOASTAL-2/-3 missed; development discontinued
Phase 3 Updated 2026-06-15
Emraclidine Pharma
Schizophrenia
Phase 2 failed; program written down
Phase 2 Updated 2026-01-22
NBI-1117568 (M4 agonist) Pharma
Schizophrenia
Phase 3 program recruiting (three registration studies plus relapse-prevention); Phase 2 in bipolar I mania
Phase 3 Updated 2025-12-24
Brenipatide (LY3537031) Pharma
Major depressive disorder; alcohol use disorder
Phase 3 recruiting in MDD and alcohol use disorder; Phase 2 in bipolar I and schizophrenia
Phase 3 Updated 2026-02-10
Seltorexant Pharma
Major depressive disorder with insomnia symptoms
MDD3001 positive; MDD3005 vs quetiapine XR missed primary endpoint (Sept 2025); additional Phase 3 recruiting
Phase 3 Updated 2025-09-22
ACP-204 Pharma
Alzheimer's disease psychosis
Seamless Phase 2/3 in Alzheimer's disease psychosis recruiting; Phase 2 in Lewy body dementia psychosis
Phase 2 Updated 2025-08-06
Fasedienol Pharma
Social anxiety disorder (acute treatment)
PALISADE-3 (Dec 2025) and PALISADE-4 (June 2026) both missed primary endpoint vs. placebo; new multi-dose Phase 3 planned pending FDA meeting
Phase 3 Updated 2026-09-22
COMP360 psilocybin Psychedelics
Treatment-resistant depression
Phase 3 complete; rolling NDA underway
Phase 3 Updated 2026-07-08
DT120 (lysergide ODT) Psychedelics
Major depressive disorder
Phase 3 positive; second trial enrolling
Phase 3 Updated 2026-06-23
DT120 (lysergide ODT) Psychedelics
Generalized anxiety disorder
Both Phase 3s positive (Voyage, Panorama); NDA filing targeted H1 2027
Phase 3 Updated 2026-09-14
MDMA-assisted therapy Psychedelics
PTSD
Pivotal trials complete; regulatory path unresolved
Phase 3 Updated 2025-06-06
HLP003 (deuterated psilocin) Psychedelics
Major depressive disorder
Breakthrough designation; Phase 3 APPROACH topline expected 2H 2026
Phase 3 Updated 2026-07-02
GH001 (inhaled mebufotenin) Psychedelics
Treatment-resistant depression
Phase 2 positive
Phase 2 Updated 2026-03-05
BPL-003 (intranasal mebufotenin) Psychedelics
Treatment-resistant depression
Phase 3 initiated; Lilly acquisition closed Sept 11, 2026
Phase 3 Updated 2026-09-11
Luvesilocin (RE104) Psychedelics
Postpartum depression
Breakthrough designation; Phase 3 planned for 2026
Phase 2 Updated 2026-02-23
TSND-201 (methylone) Psychedelics
PTSD
Phase 3 underway; IMPACT-1 Phase 2 positive; acquired by Otsuka June 2026
Phase 3 Updated 2026-06-12
Usona psilocybin (uAspire) Psychedelics
Major depressive disorder
Phase 3 uAspire primary completion Jan 2026 per registry; results and filing pending
Phase 3 Updated 2026-01-05
VLS-01 (buccal DMT) Psychedelics
Treatment-resistant depression
Phase 2b Elumina dosing complete July 2026; topline expected Q4 2026; Phase 3 in MDD planned
Phase 2 Updated 2026-07-06
HLP004 (deuterated DMT) Psychedelics
Generalized anxiety disorder
Phase 2 signal-detection topline reported March 2026 (adjunct to standard of care)
Phase 2 Updated 2026-03-05
Epidiolex (cannabidiol) Cannabis
Epilepsy; behavioral indications explored
Additional indications under study
Approved Updated 2026-02-14
Zygel (CBD transdermal gel) Cannabis
Fragile X syndrome
RECONNECT readout; FXS program phased out
Phase 3 Updated 2026-02-24
Rejoyn Digital
Major depressive disorder (adjunct)
First FDA-cleared MDD app
Approved Updated 2026-04-04
CT-155 Digital
Schizophrenia (negative symptoms)
CONVOKE Phase 3 positive; commercialization transferred to Click
Phase 3 Updated 2026-04-09
Sleepio / Daylight Digital
Insomnia and anxiety
Marketed digital therapeutics
Approved Updated 2026-01-12