Incyte Corp. filed SEC Form 8-K: Other Events
$INCY
Biotechnology: Commercial Physical & Biological Resarch
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2026
(Exact name of registrant as specified in its charter)
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| (Address of principal executive offices) | (Zip Code) | ||||
(302 ) 498-6700
(Registrant’s telephone number,
including area code)
N/A
(Former name or former address, if changed since last report.)
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Item 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 License Application (“sBLA”) for Zynyz® (retifanlimab-dlwr) injection (375mg) for an additional indication for the treatment of adult patients with metastatic non-small cell lung cancer (“NSCLC”) in combination with platinum-based chemotherapy. The sBLA was supported by positive efficacy and safety data from the Phase 3 POD1UM-304 trial announced in December 2024.
The CRL cited inspection findings (not specific to Zynyz) at Catalent Indiana, LLC (“Catalent Indiana”), part of Novo Nordisk, the third-party fill-finish facility referenced in the sBLA. The CRL cited the regulatory compliance of Catalent Indiana as the sole approvability issue, and did not cite other approvability concerns, including Zynyz’s efficacy and safety data in NSCLC or the third-party drug substance manufacturer.
Incyte Corporation is working closely with the FDA and Catalent Indiana to address the CRL and support a potential sBLA resubmission of Zynyz in NSCLC.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: March 6, 2026 | ||||||||
| INCYTE CORPORATION | ||||||||
| By: | /s/ Richard Hoffman | |||||||
| Richard Hoffman | ||||||||
| Executive Vice President and General Counsel | ||||||||
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