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Home › Condition › CNS & Neurology

Upcoming CNS & Neurology FDA decisions & readouts

Page updated ·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET
PDUFA target dates and trial readouts in CNS & neurology, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (3)

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)

Trial readouts (19)

ABOS · Oct 2026 (est.)
sabirnetug
ILMN · Oct 2026 (est.)
18F-MFBG
IMUX · Nov 2026 (est.)
IMU-838 tablets
DWTX · Dec 2026 (est.)
Halneuron
CNTA · Dec 2026 (est.)
cleminorexton
SUPN · Dec 2026 (est.)
BIS-001
ATAI · 2026-12-31
VLS-01 readout
RAPP · 2026-12-31
RAP-219 readout
DNLI · Mar 2027 (est.)
BIIB122
NMRA · 2027-03-31
NMRA-511 readout
KYTX · Apr 2027 (est.)
KYV-101
MNOV · Apr 2027 (est.)
MN-166
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
CNTA · Sep 2027 (est.)
cleminorexton
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.