Fulgent shows strong Phase 2 data for FID-007

Fulgent Genetics reported interim Phase 2 results for its cancer drug candidate FID-007 in combination with cetuximab for recurrent or metastatic head and neck squamous cell carcinoma.

Rhea-AI Filing Summary

Fulgent Genetics reported interim Phase 2 results for its cancer drug candidate FID-007 in combination with cetuximab for recurrent or metastatic head and neck squamous cell carcinoma. The data come from an open-label, randomized study presented in a full abstract at ASCO 2026.

Among 42 efficacy-evaluable patients, the combination showed an objective response rate of 60%, with median progression-free survival of 7.2 months across two dosing arms. Median duration of response was 7.4 months, and over half of responders were still responding at the data cut-off of December 20, 2025.

The safety profile was described as favorable overall, with most treatment-related side effects in grades 1–2, though grade 3–4 events such as neutropenia, anemia, leukopenia and rash occurred, and there was one grade 5 treatment-related pneumonia. Overall survival data remain immature. The abstract is available on ASCO’s site, with final presentation slides to follow on June 1, 2026.

Insights

Biotech and clinical-trials analyst

Interim Phase 2 FID-007 data show high response rate with manageable safety, but overall survival and durability remain to be confirmed.

Fulgent released interim data from an open-label, randomized Phase 2 trial of FID-007 plus cetuximab in recurrent or metastatic head and neck squamous cell carcinoma. In 42 evaluable patients, the objective response rate was 60%, with a median progression-free survival of 7.2 months across both dosing arms.

The company highlights this against historical standards of care with objective response rates of 5.8%-19.1% and progression-free survival of 2.3-3.7 months, suggesting potentially meaningful activity. Median duration of response was 7.4 months, and 56% of responders were still in response at the December 20, 2025 data cut-off.

Safety appears manageable, dominated by grade 1–2 treatment-related adverse events, though grade 3–4 hematologic and dermatologic events occurred and there was one grade 5 treatment-related pneumonia. Overall survival is still immature, so future updates, including the June 1, 2026 ASCO presentation and later trial readouts, will be important for understanding the long-term benefit–risk profile.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Objective response rate: 60% Median progression-free survival: 7.2 months Patients evaluable for efficacy: 42 patients +5 more

8 metrics

Objective response rate 60% FID-007 plus cetuximab in 42 efficacy-evaluable R/M HNSCC patients

Median progression-free survival 7.2 months Overall mPFS across both arms in Phase 2 FID-007 study

Patients evaluable for efficacy 42 patients Interim Phase 2 FID-007 plus cetuximab analysis

Responders still in response 56% (14/25) Proportion of responders ongoing at December 20, 2025 cut-off

US annual HNSCC cases 73,000 cases Estimated new head and neck squamous cell carcinoma cases per year in U.S.

Worldwide annual HNSCC cases 930,000 cases Estimated new HNSCC cases per year worldwide

Historical ORR range 5.8%–19.1% Current standard-of-care objective response rate in R/M HNSCC

Historical PFS range 2.3–3.7 months Current standard-of-care progression-free survival in R/M HNSCC

Key Terms

objective response rate (ORR), progression-free survival (PFS), treatment-related adverse events (TRAEs), open-label, randomized Phase 2 study, +2 more

6 terms

objective response rate (ORR) financial

"Of the 42 patients evaluable for efficacy, the objective response rate (ORR) was 60%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink by a pre-set amount for a minimum time, counting both complete disappearance and meaningful partial shrinkage. Investors watch ORR because it gives an early, quantitative signal that a treatment is having a direct effect on disease—like the percent of people whose fever drops after taking a medicine—which can influence expectations for later trial success, regulatory approval, and market potential.

progression-free survival (PFS) financial

"a progression-free survival (PFS) of only 2.3 to 3.7 months"

Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.

treatment-related adverse events (TRAEs) financial

"a favorable safety and tolerability profile consisting mostly of grade 1-2 treatment-related adverse events (TRAEs)"

Treatment-related adverse events (TRAEs) are unwanted symptoms or medical problems that patients experience and clinicians determine are likely caused by a drug, device, or medical procedure. Investors care because TRAEs influence a treatment’s safety profile, regulatory approval, labeling, market acceptance and potential legal or cost implications—similar to customer complaints for a product that can limit sales, trigger warnings or require fixes.

open-label, randomized Phase 2 study financial

"interim data from the Company’s open-label, randomized Phase 2 study"

nanoencapsulation and targeted therapy platform technical

"using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window"

head and neck squamous cell carcinoma (HNSCC) medical

"head and neck squamous cell carcinoma (HNSCC), Abstract #6020"

Head and neck squamous cell carcinoma (HNSCC) is a common type of cancer that arises from the flat, thin cells lining the mouth, throat, voice box and nearby areas. It matters to investors because diagnosis, treatment and clinical trial progress directly affect the commercial prospects of drugs, diagnostics and medical services; a successful new therapy can lift a company’s revenue outlook while failed trials can hurt valuations — like a weather forecast that shifts a company’s expected future.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Fulgent Genetics (FLGT) announce in its latest 8-K filing?

Fulgent Genetics announced that a full abstract with interim Phase 2 data for FID-007 in combination with cetuximab in recurrent or metastatic head and neck squamous cell carcinoma was released on the ASCO 2026 website and will be presented in a Rapid Oral Abstract Session.

What are the key efficacy results for FID-007 in Fulgent Genetics’ Phase 2 trial?

In 42 efficacy-evaluable patients, FID-007 plus cetuximab achieved a 60% objective response rate, with 58% in Arm A and 61% in Arm B. Median progression-free survival was 7.2 months overall, including 6.7 months in Arm A and 7.2 months in Arm B, based on the interim analysis.

How durable were responses to FID-007 plus cetuximab in the Fulgent Genetics study?

The median duration of response was 7.4 months overall, with 7.4 months in Arm A and not reached in Arm B at the cut-off. At the December 20, 2025 data cut-off, 56% of responders, or 14 out of 25 patients, were still responding to treatment.

What safety profile did Fulgent Genetics report for FID-007 in the Phase 2 trial?

Fulgent reported a favorable safety and tolerability profile, with most treatment-related adverse events graded 1–2. Grade 3–4 events in at least two patients included neutropenia, anemia, leukopenia, acneiform dermatitis and rash. There was one grade 5 treatment-related adverse event, pneumonia, in Arm B.

When and where will Fulgent Genetics present the FID-007 Phase 2 data at ASCO 2026?

The abstract will be presented in the Head and Neck Cancer Track Rapid Oral Abstract Session at the ASCO 2026 Annual Meeting on June 1, 2026, from 4:30pm to 6:00pm (CDT) in Hall D1 at McCormick Place in Chicago.

How does Fulgent position FID-007 relative to current treatments for head and neck cancer?

Fulgent notes that current standard-of-care regimens for recurrent or metastatic head and neck squamous cell carcinoma historically achieve objective response rates of 5.8% to 19.1% and progression-free survival of 2.3 to 3.7 months, suggesting FID-007’s interim results may represent a meaningful potential treatment option.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 05/21/2026 - 05:04 PM Learn about SEC filing dates

0001674930false00016749302026-05-212026-05-21

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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): May 21, 2026

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 May 21, 2026, Fulgent Genetics, Inc. (the “Company”) issued a press release announcing that the Company's full abstract entitled “FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020”, presenting interim data from the Company's open-label, randomized Phase 2 study, was released. 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 May 21, 2026
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: May 21, 2026	FULGENT GENETICS, INC.
	By:		/s/ Paul Kim
	Name:		Paul Kim
	Title:		Chief Financial Officer

Exhibit 99.1

Fulgent Announces Rapid Oral Full Abstract Publication for FID-007 Within the Head and Neck Cancer Track Session at the ASCO 2026 Annual Meeting

EL MONTE, Calif.—May 21, 2026—Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established laboratory services business and a therapeutic development business, today announced that its full abstract has been released on the ASCO 2026 website. The abstract will be presented within the Head and Neck Cancer Track of the American Society of Clinical Oncology (ASCO) Rapid Oral Abstract Session on June 1, 2026, from 4:30pm to 6:00pm (CDT) in Hall D1 of McCormick Place, Chicago.

The abstract is entitled “FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020”. It presents interim data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study was designed to evaluate the efficacy of two different dosing regimens and to characterize the pharmacokinetics (PK) and safety and tolerability of FID-007 in combination with cetuximab in patients with disease progression after treatment with PD-1-based immune checkpoint inhibitor. As of the data cut-off date of December 20, 2025, FID-007 exhibited meaningful clinical activity and a favorable safety profile when combined with cetuximab in target patient population.

Key observations in the abstract include:

•FID-007 combined with cetuximab demonstrated anticancer activity at both dose levels for the 1L–2L treatment of R/M HNSCC. Of the 42 patients evaluable for efficacy, the objective response rate (ORR) was 60% (58% in Arm A, 61% in Arm B), and the median progression-free survival (mPFS) was 7.2 mo [6.7 mo in Arm A (95% CI: 2.0-12.8), and 7.2 mo in Arm B (95% CI: 4.0-NR)]. The median duration of response (DoR) was 7.4 mo (7.4 mo in Arm A, NR in Arm B) with 56% (14/25) of responders continuing to respond at the time of data cut-off. The overall survival data (OS) are immature at present.

•FID-007 exhibited a favorable safety and tolerability profile consisting mostly of grade 1-2 treatment-related adverse events (TRAEs). Grade 3-4 TRAEs occurring in ≥ 2 patients included neutropenia (3 in Arm A, 5 in Arm B), anemia (2 in Arm A, 4 in Arm B), leukopenia (3 in Arm B), acneiform dermatitis (2 in Arm A), maculo-papular rash and other rash (2 in Arm B). There was 1 Grade 5 TRAE (pneumonia in Arm B).

The full abstract is now available on the ASCO® website, as well as on Fulgent’s investor relations website.

The final presentation slides with updated data will be available on Fulgent’s investor relations website at the start of the session on June 1, 2026.

Dr. Ray Yin, Co-Founder and President of Fulgent Pharma, said, “Based on available estimates, there are approximately 73,000 new head and neck Squamous Cell Carcinoma (HNSCC) cases in the U.S. and 930,000 worldwide each year, with 50% to 60% progressing to the recurrent or metastatic stage. We are encouraged by the clinical progress achieved so far and believe in the potential of FID-007 to serve as a meaningful treatment for R/M HNSCC patients, particularly given that the current standard of care offers

a historical objective response rate (ORR) of just 5.8% to 19.1% and a progression-free survival (PFS) of only 2.3 to 3.7 months.”

About Fulgent

Fulgent is a technology-based company with a well-established laboratory services business and a therapeutic development business. Fulgent’s laboratory services business includes technical laboratory and testing services and professional interpretation of laboratory results by licensed physicians. Fulgent’s therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a diagnostic business into a fully integrated precision medicine company.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: future performance; Fulgent’s research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials, the expected timing of enrollment and regulatory filings for these trials and the availability of data or results of these trials and the potential future benefits of FID-007. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Fulgent’s future performance, and they are based on management’s current assumptions, expectations, and beliefs concerning future developments and their potential effect on Fulgent’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the success of Fulgent’s development efforts, including its ability to progress its candidates through clinical trials on the timelines expected; its compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and its ability to protect its proprietary technology and intellectual property. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events. The forward-looking statements made in this press release speak only as of the date of this press release, and Fulgent assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law. Fulgent files reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 27, 2026, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Fulgent’s website upon their filing with the SEC. These reports contain more information about Fulgent, its business and the risks affecting their business.

Investor Relations Contact:

The Blueshirt Group

Lauren Sloane, Lauren@blueshirtgroup.com

Source: Fulgent Genetics, Inc.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 17.0 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 24.6 KB