FDA issues Complete Response Letter on Incyte (INCY) Zynyz NSCLC application

Rhea-AI Filing Summary

Incyte Corporation reported that on February 27, 2026, the U.S. Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Zynyz (retifanlimab-dlwr) injection in metastatic non-small cell lung cancer in combination with platinum-based chemotherapy.

The FDA’s letter cited regulatory compliance inspection findings at Catalent Indiana, the third-party fill-finish facility referenced in the application, as the sole approvability issue. The FDA did not raise concerns about Zynyz’s efficacy, safety data in NSCLC, or the third-party drug substance manufacturer. Incyte is working with the FDA and Catalent Indiana to address the letter and support a potential resubmission.

Positive

• None.

Negative

• FDA Complete Response Letter delays NSCLC expansion for Zynyz — The FDA declined to approve the sBLA for Zynyz in metastatic non-small cell lung cancer, citing regulatory compliance issues at the Catalent Indiana fill-finish facility as the sole approvability concern.

Insights

Biopharma regulatory analyst

FDA declines expanded Zynyz use over contractor compliance, not drug data.

The FDA issued a Complete Response Letter for Incyte’s sBLA seeking an additional indication for Zynyz in metastatic non-small cell lung cancer with platinum-based chemotherapy. The decision is tied to inspection findings at Catalent Indiana, the third-party fill-finish facility in the application.

Importantly, the FDA identified Catalent Indiana’s regulatory compliance as the sole approvability issue and did not question Zynyz’s efficacy and safety data in NSCLC or the third-party drug substance manufacturer. This suggests the underlying clinical package remains intact, while approval timing depends on resolving manufacturing compliance.

Incyte states it is working closely with the FDA and Catalent Indiana to address the letter and support a potential resubmission of the sBLA for Zynyz in NSCLC. Future company communications and regulatory updates will clarify the path to resubmission and any impact on launch timing for this additional indication.

FALSE000087916900008791692026-02-272026-02-27

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

INCYTE CORPORATION

(Exact name of registrant as specified in its charter)

Delaware			001-12400			94-3136539
(State or Other Jurisdiction of Incorporation)			(Commission File Number)			(I.R.S. Employer Identification No.)

1801 Augustine Cut-Off Wilmington, DE			19803
(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.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below):

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240-13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol			Name of exchange on which registered
Common Stock, $.001 par value per share			INCY			The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b—2 of the Securities Exchange Act of 1934 (§ 240.12b—2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  o

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.

2

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

3

FAQ

What did the FDA decide about Incyte (INCY) and Zynyz for lung cancer?

The FDA issued a Complete Response Letter for Incyte’s sBLA seeking an additional indication for Zynyz in metastatic non-small cell lung cancer with platinum-based chemotherapy, meaning the application was not approved and must be addressed before potential resubmission.

Why did the FDA issue a Complete Response Letter to Incyte’s Zynyz sBLA?

The Complete Response Letter cited inspection findings at Catalent Indiana, the third-party fill-finish facility in the application. The letter identified the facility’s regulatory compliance as the sole approvability issue, without raising other concerns about the Zynyz clinical data or drug substance manufacturer.

Did the FDA question Zynyz’s efficacy or safety in Incyte’s NSCLC filing?

The FDA did not cite concerns about Zynyz’s efficacy or safety data in metastatic non-small cell lung cancer. The letter specifically stated that regulatory compliance at Catalent Indiana was the only approvability issue, and did not reference problems with the third-party drug substance manufacturer.

What clinical data supported Incyte’s Zynyz sBLA for NSCLC?

The sBLA for Zynyz in metastatic non-small cell lung cancer was supported by positive efficacy and safety data from the Phase 3 POD1UM-304 trial. Those results were previously announced in December 2024 and formed the basis for seeking the additional indication in combination with platinum-based chemotherapy.

How is Incyte (INCY) responding to the FDA’s Complete Response Letter for Zynyz?

Incyte states it is working closely with the FDA and Catalent Indiana to address the issues highlighted in the Complete Response Letter. The company aims to support a potential resubmission of the supplemental Biologics License Application for Zynyz in metastatic non-small cell lung cancer.

What role does Catalent Indiana play in Incyte’s Zynyz application?

Catalent Indiana is identified as the third-party fill-finish facility referenced in the Zynyz sBLA. The FDA’s Complete Response Letter cited inspection findings at this site and described its regulatory compliance as the sole approvability issue affecting the application for the NSCLC indication.

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