INNOVATE (VATE) FDA Approvals $13.13 -0.03 (-0.26%) Closing price 05/21/2026 03:59 PM EasternExtended Trading$16.24 +3.12 (+23.76%) As of 05:03 AM 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 Adagio Medical FDA EventsAgenus FDA EventsAktis Oncology FDA EventsAkari Therapeutics FDA EventsAlign Technology FDA EventsBioCardia FDA EventsBicycle Therapeutics FDA EventsCrescent Biopharma FDA EventsCognition Therapeutics FDA EventsCompass Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsCardiff Oncology FDA EventsDenali Therapeutics FDA EventsPrecision BioSciences FDA EventsAdherex Technologies 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. We continuously monitor for new FDA events and market data. From Our PartnersSystem failure: The strongest leverage for gold…$9 trillion in U.S. debt must be refinanced in 2026 - at current rates - while the largest foreign buyers of T...Golden Portfolio | SponsoredI had never heard of this 1888 accountAn investment account dating back to 1888 has quietly delivered average annual returns of 29% over the last 25...The Oxford Club | Sponsored"Computers are about to become obsolete" - George Gilder. Here’s why.George Gilder predicted the iPhone 16 years early, called Netflix a decade before it dominated streaming, and ...Eagle Publishing | SponsoredSpaceX controls two-thirds of all satellites - and it is about to go publicSpaceX is targeting an IPO on June 11th, with trading set to begin June 12th and the roadshow kicking off June...NXT Wave Research | SponsoredHey, it's Jon Najarian. The SpaceX IPO is right around the corner. But I discovered Elon may have something BIGGER planned. Check this out before June 9th...After being invited to the SpaceX launch headquarters in Cape Canaveral from one of Elon's top lobbyists… Hall...Banyan Hill Publishing | SponsoredHow to Profit from Elon’s AI lab before it goes publicElon Musk's AI lab has partnered with the Department of Defense, Oracle, and Palantir - and he just filed conf...InvestorPlace | SponsoredI’m sounding the alarmMeta is cutting 10% of its workforce. Microsoft offered voluntary retirement to 7% of U.S. employees. Oracle, ...Porter & Company | SponsoredYour $29.97 book is free todayWhy Some Traders Skip Stocks Entirely You don't need a big account to trade options. In fact, options ca...Profits Run | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding INNOVATE Corp. Please log in to your account or sign up in order to add this asset to your watchlist. Share INNOVATE With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
