Fulgent Genetics (FLGT) FDA Approvals $16.19 +0.23 (+1.44%) Closing price 04:00 PM EasternExtended Trading$16.19 0.00 (0.00%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Fulgent Genetics' Drug in the FDA Approval ProcessThis 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 20,2025Preclinical Data Drug: FID-007Announced Date: October 20, 2025Indication: 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).AnnouncementFulgent 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 SummaryFulgent 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 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).. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Aardvark Therapeutics FDA EventsAgenus FDA EventsApyx Medical FDA EventsAtossa Genetics FDA EventsBiogen FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCelcuity FDA EventsClimb Bio FDA EventsCorvus Pharmaceuticals FDA EventsEditas Medicine FDA EventsEyepoint Pharmaceuticals FDA EventsGenprex FDA EventsGT Biopharma FDA EventsMiNK Therapeutics FDA Events 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 Related Companies CareDx FDA Events Castle Biosciences FDA Events Personalis FDA Events Burning Rock Biotech FDA Events Aclarion FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:FLGT last updated on 10/20/2025 by MarketBeat.com Staff. 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Preclinical Data - October 20,2025Preclinical Data Drug: FID-007Announced Date: October 20, 2025Indication: 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).AnnouncementFulgent 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 SummaryFulgent 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
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