Demo·seeded data·not investment advice
BioSight
ReadoutTopline Readout

DUPIXENT Pediatric AD Phase 3 Topline

REGN·DUPIXENT·Atopic Dermatitis··NCT05629468
current best date
H1
'27
HALF8 months
Takeaway

Phase 3 efficacy readout for DUPIXENT in atopic dermatitis patients aged 6 months to 5 years. DUPIXENT is currently approved for ages 6+. Watch: EASI-75 response and pruritus NRS reduction vs. placebo.

What’s at stake

market · comparables · base rate · prior moves
Market opportunity
company filings
Peer comparables
1 readout
ClinicalTrials.gov
Stage base rate
~100%
BIO Industry Analysis 2023 (2011–2020)
Avg prior-readout move
historical price reactions
Drug
mAb
DUPIXENT
dupilumab · INN
MoAIL-4Rα blocker

DUPIXENT (dupilumab) is a biologic therapy co-developed by Regeneron and Sanofi that blocks the interleukin-4 receptor alpha (IL-4Rα), shutting down the IL-4 and IL-13 signaling pathways that drive type 2 inflammation — the immune overreaction underlying atopic dermatitis, asthma, chronic sinusitis, and other allergic conditions. It is given by subcutaneous injection every two weeks and is among the most commercially successful biologic drugs of the past decade, approved across atopic dermatitis, asthma, CRS with nasal polyps, eosinophilic esophagitis, prurigo nodularis, COPD, and alopecia areata. Regeneron continues to expand its approved age range and indications in ongoing trials.

Indication
Immunology
Atopic Dermatitis
MeSH · D003876

No primer in glossary yet.

Trial
recruiting
NCT05629468
Phase 3 Dupilumab in Pediatric AD
Phase
Ph 3
N
1,200
Primary completion
Nov 30, 2026
Reference data · comparable readouts

How Appr readouts in Immunology have landed.

Reference, not prediction. We surface the historical record so you can read it yourself. We never extrapolate to the upcoming event.

Positive
0/0
0% in record
Primary endpoint hit
0%
across 0 readouts
Drug · sponsorPhase · yearOutcomeKey metricSource
litifilimab
BIIB · CLE
Ph2 · Sep 2022positiveCLASI-A 38% reductionPR
rocatinlimab
KYME · Atopic dermatitis
Ph2 · Aug 2022positiveEASI-75 56% vs 22% pboPR
sorted by phase match, then recency · sources span PR wires, CT.gov, FDA notices, and conference presentations · we never editorialize the outcome label

Competitive landscape

3 peers in Immunology · ranked by indication + modality match
DrugCompanyModalityMechanismPhaseNext catalyst
batoclimabIMVTmAbanti-FcRn mAbCONFERENCE · Apr 26
ORLADEYOberotralstatBCRXsmall moleculeplasma kallikrein inhibitorCMC · Jun 26
NTLA-2002NTLAgene therapyin vivo CRISPR knockout of KLKB1ENROLLMENT · Sep 26

Disclosure trail

1 observation · sorted by confidence
  1. Apr 8, 2026·22d agopinned · highest confidence
    MED confPR
    top claim
    H1'27
    HALF
    Topline results from the global Phase 3 study of DUPIXENT in pediatric atopic dermatitis (aged 6 months to 5 years) are expected in the first half of 2027.
    conf 82%via llm

MethodologyEvery catalyst date is anchored to a primary source. Disclosures with confidence ≥ 0.85 auto-publish; the rest are reviewed by a human within 24 hours. We never interpret data — we organize public information.

Disclaimer·BioSight aggregates publicly available data (SEC EDGAR, ClinicalTrials.gov, FDA, company press releases) and is provided as is for informational purposes only. Nothing here is investment, financial, legal, tax, or medical advice, or an offer to buy or sell any security. We make no warranty as to accuracy, completeness, or timeliness; dates and filings may contain errors or be superseded without notice; past events do not predict future outcomes. To the maximum extent permitted by law, BioSight, its operators, contributors, and affiliates disclaim all liability for any loss or damage arising from use of or reliance on this site. You are solely responsible for your own investment decisions — consult a licensed professional before acting on any information.

Unlock 12-month calendar