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Home › Condition › Immunology & Inflammation

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.
Cancer & OncologyObesity & MetabolicCNS & NeurologyCardiovascularRare DiseaseInfectious Disease & VaccinesHematologyOphthalmology & Eye

Trial readouts (49)

ZBIO · Jun 2026 (est.)
Orelabrutinib: Warm Autoimmune Hemolytic Anemia
EVMN · Jul 2026 (est.)
EVO756: Atoptic Dermatitis
TTRX · Jul 2026 (est.)
GX-03: Eczema Atopic Dermatitis
KYTX · Aug 2026 (est.)
Standard of Care Treatment: Lupus Nephritis
ACRS · Aug 2026 (est.)
A-101: Atopic Dermatitis
TMO · Aug 2026 (est.)
MK-7240: Ulcerative Colitis
APGE · Sep 2026 (est.)
APG777: Asthma
AGMB · Sep 2026 (est.)
AGMB-129: Fibrostenotic Crohn's Disease
BIIB · Sep 2026 (est.)
Litifilimab: Lupus Erythematosus, Systemic
BIIB · Sep 2026 (est.)
Litifilimab: Lupus Erythematosus, Systemic
OGN · Oct 2026 (est.)
150μg CFA (Elonva®) at stimulation day (SD) 1 and 100μg CFA(Elonva®) at SD 5: Plaque Psoriasis
IMVT · Oct 2026 (est.)
IMVT-1402: Subacute Cutaneous Lupus Erythematosus
IRON · Oct 2026 (est.)
DISC-1459: Inflammatory Bowel Disease (IBD)
BIIB · Oct 2026 (est.)
Litifilimab: Subacute Cutaneous Lupus Erythematosus
VTRS · Oct 2026 (est.)
Cenerimod: Lupus Erythematosus, Systemic
SYRE · Oct 2026 (est.)
SPY001: Rheumatoid Arthritis
APGE · Nov 2026 (est.)
APG777: Atopic Dermatitis
SNY · Nov 2026 (est.)
Rilzabrutinib: Immune Thrombocytopenia
ABVX · Dec 2026 (est.)
ABX464: Moderately to Severely Active Crohn Disease
ALMS · Dec 2026 (est.)
Open-Label Envudeucitinib: Plaque Psoriasis
APGE · Dec 2026 (est.)
APG777: Atopic Dermatitis
NKTX · Dec 2026 (est.)
NKX019: Systemic Lupus Erythematosus
RNAC · Dec 2026 (est.)
Decartes-08: Systemic Lupus Erythematosus (SLE)
ALMS · 2026-Q3
Open-Label Envudeucitinib: Plaque Psoriasis
MLTX · Jan 2027 (est.)
Sonelokimab: Arthritis, Psoriatic
XBIT · Jan 2027 (est.)
Methotrexate: Rheumatoid Arthritis
ENLV · Feb 2027 (est.)
Allocetra: Primary Knee Osteoarthritis
MLTX · Feb 2027 (est.)
Sonelokimab: Arthritis, Psoriatic
CLDX · Mar 2027 (est.)
Barzolvolimab: Mild to Moderate Asthma
CLYM · Apr 2027 (est.)
Budoprutug: Systemic Lupus Erythematosus
NKTX · Apr 2027 (est.)
NKX019: Lupus Nephritis
CRVS · Jun 2027 (est.)
Soquelitinib: Atopic Dermatitis
KYMR · Jun 2027 (est.)
KT-621: Atopic Dermatitis
KYTX · Jun 2027 (est.)
Standard of Care Treatment: Rheumatoid Arthritis
SVRA · Jun 2027 (est.)
Molgramostim: Autoimmune Pulmonary Alveolar Proteinosis
ORKA · Jun 2027 (est.)
ORKA-001: Plaque Psoriasis
ARTV · Jul 2027 (est.)
Rituximab: Rheumatoid Arthritis
ARTV · Aug 2027 (est.)
AB-101: Lupus Nephritis - WHO Class III
CLYM · Aug 2027 (est.)
Budoprutug: Immune Thrombocytopenia (ITP)
CLYM · Sep 2027 (est.)
Budoprutug: Systemic Lupus Erthematosus
IMVT · Sep 2027 (est.)
IMVT-1402: Rheumatoid Arthritis
UPB · Sep 2027 (est.)
Verekitug: Severe Asthma
JBIO · Oct 2027 (est.)
JADE101: Rhematoid Arthritis
ORKA · Oct 2027 (est.)
ORKA-001: Plaque Psoriasis
RNAC · Dec 2027 (est.)
Decartes-08: Childhood-onset Systemic Lupus Erythematous
ARWR · Dec 2027 (est.)
Plozasiran: Asthma
CANF · Dec 2027 (est.)
Piclidenoson: Plaque Psoriasis
KYMR · Dec 2027 (est.)
KT-621: Eosinophilic Asthma
LLY · Dec 2027 (est.)
Mirikizumab: Crohn's Disease
We don't show an approval percentage for these immunology & inflammation catalysts. Here's why.