---
schema_version: "secwatch.filing_event.v1"
accession: "0000879169-26-000013"
form_type: "8-K"
ticker: "INCY"
cik: "0000879169"
company_name: "INCYTE CORP"
filed_at: "2026-03-06T23:59:59+00:00"
generated_at: "2026-05-15T19:13:13.033212+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Incyte's Zynyz in NSCLC due to facility inspection findings

## Summary
- FDA CRL for Zynyz (retifanlimab) sBLA for metastatic NSCLC with platinum chemo, citing Catalent Indiana inspection findings.
- CRL did not cite efficacy or safety concerns; Zynyz's data from Phase 3 POD1UM-304 trial remains positive.
- Incyte working with FDA and Catalent Indiana to address CRL and support potential sBLA resubmission.
- The inspection findings at Catalent Indiana (part of Novo Nordisk) are not specific to Zynyz.
- No other approvability issues raised; drug substance manufacturer not a concern.

## SEC filing metadata
- accession: 0000879169-26-000013
- form_type: 8-K
- ticker: INCY
- cik: 0000879169
- company_name: INCYTE CORP
- filed_at: 2026-03-06T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/879169/000087916926000013/0000879169-26-000013-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/879169/000087916926000013/incy-20260227.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000879169-26-000013
- JSON: https://secwatch.observer/filing/0000879169-26-000013.json
- Plain text: https://secwatch.observer/filing/0000879169-26-000013.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.