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[8-K] Fulgent Genetics, Inc. Reports Material Event

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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.

Fulgent Genetics ha riportato dati clinici preliminari dal suo studio di fase 2 in corso di FID-007 in combinazione con cetuximab per una terapia di seconda linea ≤ per pazienti con carcinoma a cellule squamose della testa e del collo ricorrente o metastatico. L'azienda ha fornito un comunicato stampa con questi dettagli come Exhibit 99.1.

Fulgent Genetics informó datos clínicos preliminares de su estudio de fase 2 en curso de FID-007 en combinación con cetuximab para el tratamiento de segunda línea ≤ en pacientes con carcinoma de células escamosas de cabeza y cuello recurrente o metastásico. La empresa proporcionó un comunicado de prensa con estos detalles como Exhibit 99.1.

Fulgent Genetics는 재발 또는 전이성 두경부 편평세포암종 환자에서 재발 또는 전이성 두경부 편평세포암종의 2차 이하 치료를 위한 FID-007와 cetuximab의 병용에 대한 진행 중인 2상 연구의 예비 임상 데이터를 발표했습니다. 회사는 이 정보를 Exhibit 99.1로 보도자료로 제공했습니다.

Fulgent Genetics a rendu publics des données cliniques préliminaires issues de son étude de phase 2 en cours sur le FID-007 en association avec le cetuximab pour un traitement de 2e ligne ≤ chez les patients atteints d'un carcinome épidermoïde de la tête et du cou récurrent ou métastatique. L'entreprise a fourni un communiqué de presse avec ces détails sous Exhibit 99.1.

Fulgent Genetics gab vorläufige klinische Daten aus seiner laufenden Phase-2-Studie zu FID-007 in Kombination mit Cetuximab für die Behandlung der 2. oder weniger Linie bei Patienten mit rezidivierendem oder metastasierendem Kopf-Hals-Plattenepithelkarzinom bekannt. Das Unternehmen stellte diese Details in einer Pressemitteilung unter Exhibit 99.1 zur Verfügung.

Fulgent Genetics أعلنت عن بيانات سريرية تمهيدية من دراستها من المرحلة الثانية الجارية لـ FID-007 بالاشتراك مع cetuximab لعلاج خط ثانٍ ≤ للمرضى المصابين بسرطان الخلايا الحرشفية في الرأس والرقبة المتكرر أو النقيلي. قدمت الشركة بياناً صحفياً بهذه التفاصيل بعنوان Exhibit 99.1.

Fulgent Genetics 报告了其正在进行的 FID-007 联合 cetuximab 的二期研究初步临床数据,用于复发或转移性头颈部鳞状细胞癌患者的 ≤ 二线治疗。公司以 Exhibit 99.1 的形式提供了这份新闻稿。

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Fulgent Genetics ha riportato dati clinici preliminari dal suo studio di fase 2 in corso di FID-007 in combinazione con cetuximab per una terapia di seconda linea ≤ per pazienti con carcinoma a cellule squamose della testa e del collo ricorrente o metastatico. L'azienda ha fornito un comunicato stampa con questi dettagli come Exhibit 99.1.

Fulgent Genetics informó datos clínicos preliminares de su estudio de fase 2 en curso de FID-007 en combinación con cetuximab para el tratamiento de segunda línea ≤ en pacientes con carcinoma de células escamosas de cabeza y cuello recurrente o metastásico. La empresa proporcionó un comunicado de prensa con estos detalles como Exhibit 99.1.

Fulgent Genetics는 재발 또는 전이성 두경부 편평세포암종 환자에서 재발 또는 전이성 두경부 편평세포암종의 2차 이하 치료를 위한 FID-007와 cetuximab의 병용에 대한 진행 중인 2상 연구의 예비 임상 데이터를 발표했습니다. 회사는 이 정보를 Exhibit 99.1로 보도자료로 제공했습니다.

Fulgent Genetics a rendu publics des données cliniques préliminaires issues de son étude de phase 2 en cours sur le FID-007 en association avec le cetuximab pour un traitement de 2e ligne ≤ chez les patients atteints d'un carcinome épidermoïde de la tête et du cou récurrent ou métastatique. L'entreprise a fourni un communiqué de presse avec ces détails sous Exhibit 99.1.

Fulgent Genetics gab vorläufige klinische Daten aus seiner laufenden Phase-2-Studie zu FID-007 in Kombination mit Cetuximab für die Behandlung der 2. oder weniger Linie bei Patienten mit rezidivierendem oder metastasierendem Kopf-Hals-Plattenepithelkarzinom bekannt. Das Unternehmen stellte diese Details in einer Pressemitteilung unter Exhibit 99.1 zur Verfügung.

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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): 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).
Fulgent Genetics

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