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Upcoming Immunology & Inflammation FDA decisions & readouts

Updated ·next FDA decision on the calendar
PDUFA target dates and trial readouts in immunology & inflammation, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (2)

SVRA · 2026-11-22
MOLBREEVI (molgramostim inhalation) - (IMPALA-2): Autoimmune pulmonary alveolar proteinosis (aPAP) BLA
ARQT · 2027-02-23
ZORYVE (roflumilast) cream 0.05%: Atopic dermatitis, infants 3-24 months

Trial readouts (13)

BIIB · Sep 2026 (est.)
Litifilimab
BIIB · Oct 2026 (est.)
Litifilimab
IMVT · Oct 2026 (est.)
IMVT-1402
OGN · Oct 2026 (est.)
150μg CFA (Elonva®) at stimulation day (SD) 1 an
VTRS · Oct 2026 (est.)
Cenerimod
APGE · Nov 2026 (est.)
APG777
RNAC · Dec 2026 (est.)
Decartes-08
MLTX · Feb 2027 (est.)
Sonelokimab
KYMR · Jun 2027 (est.)
KT-621
KYTX · Jun 2027 (est.)
KYV101
ARTV · Aug 2027 (est.)
AB-101
IMVT · Sep 2027 (est.)
IMVT-1402
LLY · Dec 2027 (est.)
Mirikizumab

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

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