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Upcoming CNS & Neurology FDA decisions & readouts

Updated ยทnext FDA decision on the calendar
PDUFA target dates and trial readouts in CNS & neurology, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
Cancer & OncologyObesity & MetabolicImmunology & InflammationCardiovascularRare DiseaseInfectious Disease & VaccinesHematologyOphthalmology & Eye

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.