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.
- Drug:
- FID-007
- Announced Date:
- May 21, 2026
- Indication:
- 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Announcement
Fulgent Genetics, Inc announced that its full abstract has been released on the ASCO 2026 website.
AI Summary
Fulgent Genetics, Inc. said its full abstract is now available on the ASCO 2026 website. The release gives investors and researchers a closer look at the company’s latest oncology-related findings. The abstract highlights key observations from the study, showing the main results and early data that Fulgent wants to share with the medical community.
This update matters because ASCO is one of the most important cancer research meetings in the world. Having the full abstract posted online allows doctors, scientists, and investors to review the details ahead of the conference. Fulgent said the information reflects its ongoing work in precision medicine and cancer testing, and it may help guide future research and product development.
The company also included standard forward-looking statement language and investor contact information in the announcement.
Read Announcement- 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).
Announcement
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).
AI Summary
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.
Read Announcement
Fulgent Genetics FDA Events - Frequently Asked Questions
As of now, Fulgent Genetics (FLGT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Fulgent Genetics (FLGT) has reported FDA regulatory activity for FID-007.
The most recent FDA-related event for Fulgent Genetics occurred on May 21, 2026, involving FID-007. The update was categorized as "Abstract," with the company reporting: "Fulgent Genetics, Inc announced that its full abstract has been released on the ASCO 2026 website."
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)..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:FLGT last updated on 5/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
