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Upcoming CNS & Neurology FDA decisions & readouts

PDUFA target dates and trial readouts in CNS and neurological disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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Trial readouts (70)

CMPS · Jun 2026 (est.)
COMP360 psilocybin — Major Depressive Disorder
DWTX · Jul 2026 (est.)
Halneuron — Chemotherapy Induced Neuropathic Pain
DFTX · Jul 2026 (est.)
DT120 — Generalized Anxiety Disorder
AXSM · Jul 2026 (est.)
AXS-14 — Major Depressive Disorder (MDD)
ILMN · Jul 2026 (est.)
18F-MFBG — Neuroblastoma
HELP · Aug 2026 (est.)
CYB003 — Major Depressive Disorder
IGC · Aug 2026 (est.)
IGC-AD1-Active — Alzheimer Disease
DFTX · Aug 2026 (est.)
DT120 — Generalized Anxiety Disorder
ENSC · Aug 2026 (est.)
PF614 capsule — Postoperative Pain, Acute
MPLT · Aug 2026 (est.)
ML-007C-MA — Schizophrenia
XENE · Aug 2026 (est.)
Azetukalner — Major Depressive Disorder
ANRO · Aug 2026 (est.)
ALTO-100 — Bipolar Disorder I or II With a Major Depressive Episode
RAPP · Sep 2026 (est.)
RAP-219 — Bipolar 1 Disorder
ILMN · Sep 2026 (est.)
18F-MFBG — Parkinson Disease (PD)
ALEC · Sep 2026 (est.)
AL001 — Alzheimer's Disease
XENE · Oct 2026 (est.)
Azetukalner — Focal Onset Seizures
ABOS · Oct 2026 (est.)
sabirnetug — Alzheimer Disease
CORT · Oct 2026 (est.)
Relacorilant — Amyotrophic Lateral Sclerosis
IMUX · Nov 2026 (est.)
IMU-838 tablets — Multiple Sclerosis
QURE · Nov 2026 (est.)
AMT-260 — Mesial Temporal Lobe Epilepsy
BHVN · Dec 2026 (est.)
BHV-7000 — Focal Epilepsy
ALZN · Dec 2026 (est.)
AL001 — Bipolar I Disorder
ANRO · Dec 2026 (est.)
ALTO-300 — Major Depressive Disorder
VNDA · Dec 2026 (est.)
VQW-765 — Social Anxiety Disorder (SAD)
SNY · Dec 2026 (est.)
Rilzabrutinib — Focal Segmental Glomerulosclerosis
SUPN · Dec 2026 (est.)
BIS-001 — Focal Impaired Awareness Seizures
PLYX · Dec 2026 (est.)
PLX-200 — Juvenile Neuronal Ceroid Lipofuscinosis
HELP · 2026-Q1
CYB003 — Major Depressive Disorder
ZURA · 2026-Q3
Tibulizumab — Systemic Sclerosis (SSc)
HELP · 2026-Q4
CYB003 — Major Depressive Disorder
COYA · Jan 2027 (est.)
COYA 302 — Amyotrophic Lateral Sclerosis (ALS)
XENE · Jan 2027 (est.)
Azetukalner — Major Depressive Disorder
SPTX · Mar 2027 (est.)
SPT-300 — Major Depressive Disorder (MDD)
DNLI · Mar 2027 (est.)
BIIB122 — Parkinson Disease
TVTX · Mar 2027 (est.)
Pegtibatinase — Focal Segmental Glomerulosclerosis
HELP · Mar 2027 (est.)
CYB003 — Major Depressive Disorder (MDD)
CGTX · Apr 2027 (est.)
Dextromethorphan-Bupropion — Early Alzheimer's Disease
KYTX · Apr 2027 (est.)
Standard of Care Treatment — Multiple Sclerosis, Primary Progressive
MNOV · Apr 2027 (est.)
MN-166 — Amyotrophic Lateral Sclerosis
XENE · Apr 2027 (est.)
Azetukalner — Primary Generalized Tonic-Clonic Seizures
TLX · Apr 2027 (est.)
177Lu-TLX591 — Bone Pain
VYGR · May 2027 (est.)
VY7523 — Alzheimer's Disease (AD)
XENE · May 2027 (est.)
Azetukalner — Major Depressive Disorder
ZURA · May 2027 (est.)
Tibulizumab — Systemic Sclerosis (SSc)
SPTX · May 2027 (est.)
SPT-300 — Major Depressive Disorder (MDD)
ARWR · Jun 2027 (est.)
Plozasiran — Alzheimer Disease
LBRX · Jun 2027 (est.)
LB-102 — Schizophrenia
LNTH · Jun 2027 (est.)
PI-2620 — Alzheimer Disease
NMRA · Jun 2027 (est.)
NMRA-335140 — Major Depressive Disorder
NBIX · Jul 2027 (est.)
NBI-1065845 — Major Depressive Disorder
NTLA · Jul 2027 (est.)
NTLA-2002 — Neuromuscular Disease
TGTX · Jul 2027 (est.)
Ublituximab — Multiple Sclerosis
BTAI · Jul 2027 (est.)
Sublingual film containing dexmedetomidine — Schizophrenia
SUPN · Aug 2027 (est.)
SPN-817 — Focal Onset Seizures
ACAD · Aug 2027 (est.)
ACP-204 — Major Depressive Disorder (MDD)
NBIX · Aug 2027 (est.)
NBI-1065845 — Schizophrenia
BHVN · Aug 2027 (est.)
BHV-8000 — Parkinson Disease
ALKS · Sep 2027 (est.)
Olz/Sam — Bipolar I Disorder
DFTX · Sep 2027 (est.)
DT120 — Major Depressive Disorder
EVMN · Oct 2027 (est.)
EVO756 — Migraine
NBIX · Oct 2027 (est.)
NBI-1065845 — Schizophrenia
NBIX · Nov 2027 (est.)
NBI-1065845 — Schizophrenia
ANRO · Nov 2027 (est.)
ALTO-207 — Treatment-resistant Depression (TRD)
SRPT · Nov 2027 (est.)
SRP-1005 — Huntington's Disease
ANVS · Dec 2027 (est.)
buntanetap/posiphen — Early Alzheimers Disease
JNJ · Dec 2027 (est.)
Apathy — Parkinson Disease
MPLT · Dec 2027 (est.)
ML-007C-MA — Psychosis Associated With Alzheimer's Disease
NERV · Dec 2027 (est.)
Roluperidone — Negative Symptoms of Schizophrenia
QGEN · Dec 2027 (est.)
INCB161734 — Parkinson Disease
SPTX · 2027-H1
SPT-300 — Major Depressive Disorder (MDD)
We don't show an approval percentage for these cns & neurology catalysts — here's why.