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Upcoming Immunology & Inflammation FDA decisions & readouts

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
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 (6)

SVRA · 2026-11-22
MOLBREEVI (molgramostim inhalation) - (IMPALA-2): Autoimmune pulmonary alveolar proteinosis (aPAP) BLA
RHHBY · Dec 2026 (est.)
Gazyva (obinutuzumab) - systemic lupus erythematosus (ALLEGORY): Systemic lupus erythematosus (SLE)
PHAR · 2027-01-30
Joenja (leniolisib) lower doses - APDS, ages 4+ from 13 kg (sNDA): Activated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation)
ARQT · 2027-02-23
ZORYVE (roflumilast) cream 0.05%: Atopic dermatitis, infants 3-24 months
AQST · 2027-03-16
Anaphylm (dibutepinephrine) sublingual film - NDA resubmission: Anaphylaxis (Class 2 resubmission after the January 30, 2026 CRL)
ZBIO · 2027-05-27
Obexelimab - IgG4-related disease: IgG4-related disease

Trial readouts (12)

APGE · Nov 2026 (est.)
APG777
RNAC · Dec 2026 (est.)
Decartes-08
KYTX · Feb 2027 (est.)
KYV-101
TTRX · 2027-03-31
GX-03 readout: moderate-to-severe atopic dermatitis
KYMR · Jun 2027 (est.)
KT-621
KYTX · Jun 2027 (est.)
KYV101
ARTV · Aug 2027 (est.)
AB-101
IMVT · Sep 2027 (est.)
IMVT-1402
INCY · Sep 2027 (est.)
Corticosteroids
LLY · Dec 2027 (est.)
Mirikizumab
IMA · 2027-12-31
olevaprubart (IMG-007) ADAPTIVE Phase 2b: moderate-to-severe atopic dermatitis
TRXB · 2027-12-31
TRB-061 (TNFR2 agonist) Phase 1a/b, Phase 1b portion: moderate-to-severe atopic dermatitis

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.