FLGT files 8-K on FID-007 + cetuximab phase 2 preliminary data

Rhea-AI Filing Summary

Fulgent Genetics reported preliminary clinical data from its ongoing phase 2 study of FID-007 in combination with cetuximab for ≤ 2nd line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma. The company furnished a press release with these details as Exhibit 99.1.

false000167493000016749302025-10-202025-10-20

!

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): October 20, 2025

FULGENT GENETICS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware	001-37894	81-2621304
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

4399 Santa Anita Avenue El Monte, California	91731
(Address of Principal Executive Offices)	(Zip Code)

(626) 350-0537

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	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(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		FLGT		The Nasdaq Stock Market  (Nasdaq Global Market)

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. ☐

Item 8.01 Other Events.

On October 20, 2025, Fulgent Genetics, Inc. (the “Company”) issued a press release announcing preliminary clinical data from the ongoing phase 2 trial of FID-007 in combination with cetuximab in ≤ 2nd line treatment in patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). A copy of the Company’s press release containing this information is filed as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release dated October 20, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: October 20, 2025	FULGENT GENETICS, INC.
	By:		/s/ Paul Kim
	Name:		Paul Kim
	Title:		Chief Financial Officer

FAQ

What did Fulgent Genetics (FLGT) announce in this 8-K?

The company announced preliminary clinical data from an ongoing phase 2 trial of FID-007 plus cetuximab in R/M HNSCC.

Which patient population is included in the FID-007 study?

Patients with recurrent or metastatic head and neck squamous cell carcinoma in ≤ 2nd line treatment.

What is the treatment combination being studied?

FID-007 in combination with cetuximab.

What stage is the clinical study?

Phase 2 and ongoing.

Where can I find more details about the preliminary data?

Details are in the press release furnished as Exhibit 99.1.

What form did Fulgent Genetics file?

A Form 8-K under Item 8.01 (Other Events).