8-K - Incyte Corporation | StockGist

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Incyte Corporation disclosed that on February 27, 2026, the FDA issued a Complete Response Letter for the sBLA of Zynyz® (retifanlimab-dlwr) for metastatic NSCLC in combination with platinum-based chemotherapy, citing inspection findings at third-party fill-finish facility Catalent Indiana as the sole approvability issue. Incyte is working with the FDA and Catalent Indiana to address the CRL for potential resubmission.

Key Takeaways

1FDA issued CRL on February 27, 2026 for Zynyz sBLA

2sBLA seeks indication for adult patients with metastatic NSCLC in combination with platinum-based chemotherapy

3CRL supported by Phase 3 POD1UM-304 trial data announced December 2024

4Sole issue: inspection findings at Catalent Indiana, part of Novo Nordisk

5No concerns raised on Zynyz efficacy, safety data or drug substance manufacturer

6Incyte working with FDA and Catalent Indiana for potential sBLA resubmission

Current Report Details

Event Type

Other Event

Disclosure

Voluntary

Variant

8-K

Items Reported

8.01

Other Events. On February 27, 2026, the U.S. Food and Drug Administration (“FDA”) issued a Complete Response Letter (“CRL”) for the supplemental Biologics Licen

Other Event

Exhibits (1)

8-K