Strong FID-007 Phase 2 results for Fulgent Genetics (NASDAQ: FLGT)

(High)

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Fulgent Genetics filed an 8-K to share updated clinical data for its cancer drug candidate FID-007. The company presented preliminary Phase 2 results at the ASCO 2026 Annual Meeting in a rapid oral abstract session focused on head and neck cancer.

The open-label, randomized Phase 2 study evaluates two dosing regimens of FID-007 combined with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after PD-1–based immunotherapy. As of the April 16, 2026 data cutoff, investigators reported meaningful clinical activity and a manageable safety profile.

According to a principal investigator, the combination produced an objective response rate of 61.9%, median progression-free survival of 6.7 months, median duration of response of 7.4 months, and one-year overall survival of 63.4%. A Phase 3 study of FID-007 is planned, and the ASCO presentation slides are being made available on Fulgent’s investor relations website.

Positive

Encouraging Phase 2 efficacy data for FID-007: In PD-1–refractory recurrent or metastatic head and neck squamous cell carcinoma, FID-007 plus cetuximab showed a 61.9% objective response rate, 6.7‑month median progression-free survival, 7.4‑month median duration of response, and 63.4% one-year overall survival, with a manageable safety profile and a Phase 3 study planned.

Negative

None.

Insights

FID-007 shows promising Phase 2 efficacy signals in difficult head and neck cancer.

Fulgent reported updated preliminary Phase 2 data for FID-007 plus cetuximab in recurrent or metastatic head and neck squamous cell carcinoma after PD-1 therapy. This is a high‑need setting with no established best second-line standard of care, so any strong signal can be noteworthy.

As of the April 16, 2026 cutoff, the investigator cited an objective response rate of 61.9%, median progression-free survival of 6.7 months, median duration of response of 7.4 months, and one‑year overall survival of 63.4%, alongside a manageable safety profile. These metrics, while still early and from a preliminary dataset, compare favorably to typical expectations in this population.

The company states that a Phase 3 study is planned, which would be necessary to confirm benefit and support any potential approval. Actual impact will depend on full Phase 2 data, Phase 3 design, and whether similar efficacy and safety are reproduced in larger, controlled studies.

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, and exhibit attachments filed with this report.

Key Figures

Objective response rate: 61.9% Median progression-free survival: 6.7 months Median duration of response: 7.4 months +3 more

6 metrics

Objective response rate 61.9% FID-007 plus cetuximab in R/M HNSCC as of April 16, 2026

Median progression-free survival 6.7 months FID-007 combination Phase 2 study in R/M HNSCC

Median duration of response 7.4 months Preliminary Phase 2 data for FID-007 plus cetuximab

One-year overall survival 63.4% Patients treated with FID-007 plus cetuximab after PD-1 therapy

Data cutoff date April 16, 2026 Reference date for reported FID-007 clinical outcomes

ASCO 2026 session time 4:30–6:00 p.m. CDT Rapid Oral Abstract Session in Hall D1, McCormick Place

Key Terms

Phase 2 study, objective response rate, progression-free survival, head and neck squamous cell carcinoma, +2 more

6 terms

Phase 2 study financial

"updated preliminary data from the Company’s open-label, randomized Phase 2 study (NCT06332092)"

A phase 2 study is a mid-stage clinical trial that tests whether an experimental drug or treatment actually works for the intended condition and continues to check safety in a larger group of patients than early trials. Think of it as a focused pilot test before a full market launch; positive or negative results strongly affect a drug’s chances of approval, the remaining development time and costs, and therefore an investment’s risk and potential value.

objective response rate financial

"The objective response rate was 61.9%, median progression-free survival was 6.7 months"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival financial

"median progression-free survival was 6.7 months, median duration of response was 7.4 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

head and neck squamous cell carcinoma medical

"in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020"

A type of cancer that starts in the thin, flat cells that line the mouth, throat, voice box and upper airway; imagine the lining like roof shingles that, when damaged, can grow into a harmful lump. It matters to investors because its diagnosis, treatment options and regulatory approvals drive demand for drugs, tests and therapies—affecting clinical trial outcomes, market size, company valuations and the financial risk/reward of healthcare investments.

nanoencapsulation technical

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

immune checkpoint inhibitor therapy medical

"patients whose disease progressed following PD-1 based immune checkpoint inhibitor therapy"

Immune checkpoint inhibitor therapy is a type of cancer treatment that releases natural “brakes” on the immune system so white blood cells can recognize and attack tumors. Think of it as taking the hand off a guard dog so it can chase an intruder more effectively, but sometimes the dog can also chase the wrong targets. Investors watch these drugs because they can create large markets, hinge on regulatory approvals and patient tests, and carry safety or competition risks that affect revenues.

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

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Understanding 8-K Material Events →

Available on EDGAR 06/02/2026 - 06:06 AM Accepted by SEC EDGAR 06/01/2026 - 07:07 PM

FAQ

What did Fulgent Genetics (FLGT) announce about FID-007 in this 8-K?

Fulgent Genetics reported updated preliminary Phase 2 data for FID-007 in combination with cetuximab in recurrent or metastatic head and neck squamous cell carcinoma after PD-1 therapy. The results were presented at ASCO 2026 and showed meaningful clinical activity with a manageable safety profile.

What are the key efficacy results for FID-007 reported by Fulgent Genetics?

The preliminary data showed an objective response rate of 61.9%, median progression-free survival of 6.7 months, median duration of response of 7.4 months, and one-year overall survival of 63.4% for FID-007 plus cetuximab in the targeted patient population, as of the April 16, 2026 data cutoff.

Which patient population is Fulgent’s FID-007 targeting in this Phase 2 study?

FID-007 is being evaluated in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after PD-1 based immune checkpoint inhibitor therapy. This group lacks an established best second-line standard of care, making new treatment options particularly important.

Where and when were Fulgent Genetics’ FID-007 results presented?

The updated FID-007 data were presented in the Head and Neck Cancer Track during the ASCO 2026 Annual Meeting Rapid Oral Abstract Session, scheduled from 4:30 p.m. to 6:00 p.m. CDT in Hall D1 at McCormick Place in Chicago, as described by the company.

Is Fulgent Genetics planning further trials for FID-007 after this Phase 2 study?

Yes. The company stated that a Phase 3 study is planned for FID-007. Advancing to Phase 3 is an important step toward confirming the preliminary Phase 2 efficacy and safety findings in a larger, more definitive clinical trial setting.

How can investors access the detailed FID-007 ASCO 2026 presentation from Fulgent?

Fulgent indicated that the presentation slides with updated FID-007 data will be available on its investor relations website at the conclusion of the ASCO 2026 session. This provides direct access to the clinical details beyond the headline efficacy statistics.

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): June 1, 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 June 1, 2026, Fulgent Genetics, Inc. (the “Company”) issued a press release announcing that the Company will present updated data in the Head and Neck Cancer Track during the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting Rapid Oral Abstract Session based on 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”, previously released on May 21, 2026. 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 June 1, 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: June 1, 2026	FULGENT GENETICS, INC.

	By:	/s/ Paul Kim
	Name:	Paul Kim
	Title:	Chief Financial Officer

Exhibit 99.1

Fulgent Presents Updated FID-007 Data at ASCO 2026

EL MONTE, Calif.—June 1, 2026—Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with established laboratory services and therapeutic development businesses, today announced it presented updated data in the Head and Neck Cancer Track during the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting Rapid Oral Abstract Session, scheduled from 4:30 p.m. to 6:00 p.m. CDT in Hall D1 at McCormick Place in Chicago.

The abstract, entitled “FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020,” will present updated preliminary data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study is evaluating the efficacy of two dosing regimens and characterizing the pharmacokinetics, safety, and tolerability of FID-007 in combination with cetuximab in patients whose disease progressed following PD-1 based immune checkpoint inhibitor therapy. As of the April 16, 2026, data cutoff, FID-007 demonstrated meaningful clinical activity and a manageable safety profile in combination with cetuximab in this target patient population.

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

Dr. Guilherme Rabinowits, one of the study’s Principal Investigators and a Senior Member in the Department of Head and Neck-Endocrine Oncology at Moffitt Cancer Center said: “Patients with R/M HNSCC who progress after anti PD-1 based therapy lack an established, best second-line standard of care. In this setting, preliminary data showed encouraging clinical activity and a manageable safety profile for FID-007 in combination with cetuximab. The objective response rate was 61.9%, median progression-free survival was 6.7 months, median duration of response was 7.4 months, and one-year overall survival was 63.4%. Additionally, this combination showed activity in both human papilloma virus-related and -unrelated head and neck squamous cell carcinoma.” A Phase 3 study is planned.

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.

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

2 documents

Press Releases

EX-99.1 EX-99.1 14.1 KB