pdufa.bio
CalendarReadoutsDevicesDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › Condition › Immunology & Inflammation

Upcoming Immunology & Inflammation FDA decisions & readouts

PDUFA target dates and trial readouts in immune and inflammatory disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
Cancer & OncologyObesity & MetabolicCNS & NeurologyCardiovascularRare DiseaseInfectious Disease & VaccinesHematology

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.