INNOVATE (VATE) FDA Approvals $16.52 -2.15 (-11.50%) Closing price 03:59 PM EasternExtended Trading$16.62 +0.10 (+0.59%) 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 EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock INNOVATE's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by INNOVATE (VATE). Over the past two years, INNOVATE has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Lumitrace. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Lumitrace FDA Regulatory Events Lumitrace is a drug developed by INNOVATE for the following indication: for the assessment of kidney function in patients with normal or impaired renal function. 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. Approved - October 21,2025Approved National Medical Products AdministrationDrug: LumitraceAnnounced Date: October 21, 2025Indication: for the assessment of kidney function in patients with normal or impaired renal function.AnnouncementINNOVATE Corp. announced that it has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). Lumitrace will be sold as an integral component of the Transdermal GFR System in China.Read Announcement INNOVATE FDA Events - Frequently Asked Questions Has INNOVATE received FDA approval? As of now, INNOVATE (VATE) has not received any FDA approvals for its therapy in the last two years. What drugs has INNOVATE submitted to the FDA? In the past two years, INNOVATE (VATE) has reported FDA regulatory activity for Lumitrace. What is the most recent FDA event for INNOVATE? The most recent FDA-related event for INNOVATE occurred on October 21, 2025, involving Lumitrace. The update was categorized as "Approved," with the company reporting: "INNOVATE Corp. announced that it has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). Lumitrace will be sold as an integral component of the Transdermal GFR System in China." What conditions do INNOVATE's current drugs treat? Currently, INNOVATE has one therapy (Lumitrace) targeting the following condition: for the assessment of kidney function in patients with normal or impaired renal function.. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Artelo Biosciences FDA EventsBiogen FDA EventsNLS Pharmaceutics FDA EventsAC Immune FDA EventsAptevo Therapeutics FDA EventsHeartBeam FDA EventsCandel Therapeutics FDA EventsCogent Biosciences FDA EventsDesign Therapeutics FDA EventsMoleculin Biotech FDA EventsNovoCure FDA EventsSCYNEXIS FDA EventsSarepta Therapeutics FDA EventsStoke Therapeutics FDA EventsVistaGen 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 Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NYSE:VATE last updated on 10/21/2025 by MarketBeat.com Staff. 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Approved - October 21,2025Approved National Medical Products AdministrationDrug: LumitraceAnnounced Date: October 21, 2025Indication: for the assessment of kidney function in patients with normal or impaired renal function.AnnouncementINNOVATE Corp. announced that it has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). Lumitrace will be sold as an integral component of the Transdermal GFR System in China.Read Announcement
