Fulgent Genetics (FLGT) FDA Approvals

Fulgent Genetics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Fulgent Genetics (FLGT). Over the past two years, Fulgent Genetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FID-007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

FID-007 FDA Regulatory Events

FID-007 is a drug developed by Fulgent Genetics for the following indication: 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Preclinical Data - October 20,2025

• Drug: FID-007
• Announced Date: October 20, 2025
• Indication: 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Fulgent Genetics, Inc. announced preliminary clinical data as of September 25, 2025, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in ≤ 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Fulgent Genetics announced preliminary data as of September 25, 2025, from its phase 2 study of FID-007 plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. The results will be shared October 20 at the ESMO Congress in Berlin.

Of 39 randomized patients (36 treated), the objective response rate was 44% at 75 mg/m2 and 59% at 125 mg/m2, for an overall 51%. Median progression-free survival was 9.2 months and 7.8 months in the two arms, compared to a 2.3-month historical benchmark.

Safety was acceptable, with a 6% serious adverse event rate. Grade 3 or higher side effects included decreased blood counts, anemia, rash and pneumonia. No grade 3 or higher peripheral neuropathy was seen.

An optimal dose will be selected after further data analysis to guide the next steps in development.

Fulgent Genetics FDA Events - Frequently Asked Questions

Has Fulgent Genetics received FDA approval?

As of now, Fulgent Genetics (FLGT) has not received any FDA approvals for its therapy in the last two years.

What drugs has Fulgent Genetics submitted to the FDA?

In the past two years, Fulgent Genetics (FLGT) has reported FDA regulatory activity for FID-007.

What is the most recent FDA event for Fulgent Genetics?

The most recent FDA-related event for Fulgent Genetics occurred on October 20, 2025, involving FID-007. The update was categorized as "Preclinical Data," with the company reporting: "Fulgent Genetics, Inc. announced preliminary clinical data as of September 25, 2025, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in ≤ 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)."

What conditions do Fulgent Genetics' current drugs treat?

Currently, Fulgent Genetics has one therapy (FID-007) targeting the following condition: 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)..