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Home › Condition › CNS & Neurology

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

PDUFA decisions (4)

BTAI · 2026-11-14
IGALMI (dexmedetomidine sublingual film) - (SERENITY At-Home): At-home agitation in bipolar disorder or schizophrenia (sNDA)
PRAX · 2026-12-27
Relutrigine (PRAX-562) - (EMBOLD): Developmental epileptic encephalopathies (DEEs)
VTRS · 2026-12-27
MR-107A-02 (fast-acting meloxicam): Moderate-to-severe acute pain (non-opioid)
ABBV · Dec 2026 (est.)
Tavapadon (TEMPO): Early Parkinson's disease

Trial readouts (11)

ALEC · Sep 2026 (est.)
AL001
ALZN · 2026-09-30
AL001 Phase II topline (bipolar disorder)
ABOS · Oct 2026 (est.)
sabirnetug
ILMN · Oct 2026 (est.)
18F-MFBG
DNLI · Mar 2027 (est.)
BIIB122
CGTX · May 2027 (est.)
Dextromethorphan-Bupropion
VYGR · May 2027 (est.)
VY7523
LNTH · Jun 2027 (est.)
PI-2620
BTAI · Jul 2027 (est.)
Sublingual film containing dexmedetomidine
ANVS · Dec 2027 (est.)
buntanetap/posiphen
CMPS · Jun 2028 (est.)
COMP360 psilocybin

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

We don't show an approval percentage for these cns & neurology catalysts: here's why.