Saturday, May 30, 2026 U.S. Edition · Independent
Markets
CMPS 13.00 ▲ 9.06%
ATAI 4.57 ▲ 3.63%
GHRS 23.78 ▲ 6.26%
AXSM 233.72 ▲ 0.38%
NBIX 158.06 ▲ 1.07%
ACAD 21.82 ▲ 0.88%
LLY 1095.92 ▼ 2.74%
JNJ 226.73 ▼ 1.76%
ABBV 216.57 ▼ 0.94%
CURLF 3.56 ▲ 12.66%
GTBIF 8.01 ▲ 5.67%
TCNNF 9.67 ▲ 14.62%
VRNO 1.19 ▲ 6.25%
TLRY 5.59 ▼ 1.06%
CGC 1.11 ▼ 0.89%
MSOS 5.04 ▼ 1.56%
MJ 27.18 ▼ 0.18%
TDOC 7.94 ▲ 5.73%
HIMS 26.16 ▲ 3.07%
TALK 5.20 ▲ 0.19%
LFMD 4.37 ▼ 4.79%
ACHC 23.26 ▼ 2.10%
UHS 149.49 ▼ 0.42%
CMPS 13.00 ▲ 9.06%
ATAI 4.57 ▲ 3.63%
GHRS 23.78 ▲ 6.26%
AXSM 233.72 ▲ 0.38%
NBIX 158.06 ▲ 1.07%
ACAD 21.82 ▲ 0.88%
LLY 1095.92 ▼ 2.74%
JNJ 226.73 ▼ 1.76%
ABBV 216.57 ▼ 0.94%
CURLF 3.56 ▲ 12.66%
GTBIF 8.01 ▲ 5.67%
TCNNF 9.67 ▲ 14.62%
VRNO 1.19 ▲ 6.25%
TLRY 5.59 ▼ 1.06%
CGC 1.11 ▼ 0.89%
MSOS 5.04 ▼ 1.56%
MJ 27.18 ▼ 0.18%
TDOC 7.94 ▲ 5.73%
HIMS 26.16 ▲ 3.07%
TALK 5.20 ▲ 0.19%
LFMD 4.37 ▼ 4.79%
ACHC 23.26 ▼ 2.10%
UHS 149.49 ▼ 0.42%
Opinion

Read the executive order as a process change, not a methodological one

The voucher list does the talking. The same FDA that issued the Lykos CRL still issued the vouchers, and it sent them to programs whose methods it considers defensible. Sponsors who hear political acceleration as scientific accommodation will misread it as the field misread the original draft guidance, and pay the same kind of price.

regulation

FDA issues first psychedelic priority vouchers to Compass, Usona, and Otsuka. Resilient passed over.

Six days after Trump's executive order, the agency named three programs for one-to-two-month reviews. The picks reset the field's near-term hierarchy and confirm the methodological reasons the MDMA program is still on the outside.

The desks

Pharma

Coverage launching soon

First reporting in this vertical publishes this week.

Psychedelics

Coverage launching soon

First reporting in this vertical publishes this week.

Cannabis

Coverage launching soon

First reporting in this vertical publishes this week.

Digital health

Coverage launching soon

First reporting in this vertical publishes this week.

Pipeline

Key programs in development · scroll →
Approved

Zuranolone (Zurzuvae)

Postpartum depression

Sage Therapeutics / Biogen Marketed for PPD; MDD rejected
Approved

AXS-05 (Auvelity)

Major depressive disorder

Axsome Therapeutics Marketed; Alzheimer's agitation filed
Approved

Esketamine (Spravato)

Treatment-resistant depression

Johnson & Johnson Monotherapy label cleared
Approved

Cobenfy (xanomeline-trospium)

Schizophrenia

Bristol Myers Squibb Adjunctive MDD trials underway
Phase 3

Navacaprant (NMRA-140)

Major depressive disorder

Neumora Therapeutics KOAST program enrolling
Phase 2

Emraclidine

Schizophrenia

AbbVie (Cerevel) Phase 2 missed; under review
Phase 3

COMP360 psilocybin

Treatment-resistant depression

Compass Pathways Topline data expected
Phase 3

MM120 (LSD D-tartrate)

Generalized anxiety disorder

Mind Medicine Breakthrough designation
NDA Filed

MDMA-assisted therapy

PTSD

Lykos Therapeutics Resubmission planned after CRL
Phase 3

CYB003 (deuterated psilocin)

Major depressive disorder

Cybin Breakthrough designation
Phase 2

GH001 (inhaled mebufotenin)

Treatment-resistant depression

GH Research Readout pending
Phase 2

BPL-003 (intranasal mebufotenin)

Treatment-resistant depression

atai / Beckley Psytech Topline positive
Approved

Epidiolex (cannabidiol)

Epilepsy; behavioral indications explored

Jazz Pharmaceuticals Follow-on indications in study
Phase 3

Nabiximols (Sativex)

Multiple sclerosis spasticity

Jazz Pharmaceuticals U.S. program ongoing
Phase 3

Zygel (CBD transdermal gel)

Fragile X syndrome

Harmony Biosciences Pivotal readout expected
Approved

Rejoyn

Major depressive disorder (adjunct)

Otsuka / Click Therapeutics First FDA-cleared MDD app
Phase 3

CT-155

Schizophrenia (negative symptoms)

Boehringer Ingelheim / Click Pivotal trial enrolling
Approved

Sleepio / Daylight

Insomnia and anxiety

Big Health Marketed digital therapeutics

Analysis

Analysis

Cannabis rescheduling: what an actual schedule III decision changes for operators

Most coverage of rescheduling fixates on 280E tax relief. The bigger story is what happens to research registration, FDA pathway access, and the M&A market for MSOs that have been frozen out of institutional capital for a decade.

Analysis

Sage's zuranolone disappointment and the structural problem with PPD-only labels

When the FDA approved zuranolone for postpartum depression but rejected it for major depressive disorder, it built a commercial trap that the company has been unable to escape. The lesson generalizes.

Analysis

Hims, Talkspace, and the coming reckoning on telehealth psychiatry margins

Direct-to-consumer mental health platforms built businesses on the difference between cash-pay convenience and insurance reimbursement complexity. That gap is closing on both sides at once.

Start here

Understanding mental health

Plain-language context behind the industry headlines — no jargon, no hype.