KORU Medical Systems (KRMD) FDA Approvals $3.23 +0.01 (+0.31%) Closing price 09/18/2026 04:00 PM EasternExtended Trading$3.13 -0.10 (-3.07%) As of 09/18/2026 07:55 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 EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest KORU Medical Systems' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by KORU Medical Systems (KRMD). Over the past two years, KORU Medical Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FreedomEdge. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. FreedomEdge FDA Regulatory Events FreedomEdge is a drug developed by KORU Medical Systems for the following indication: Infusion system to deliver pegcetacoplan 20 mL solution. 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. Provided Update - December 30,2025Provided Update Drug: FreedomEdgeAnnounced Date: December 30, 2025Indication: Infusion system to deliver pegcetacoplan 20 mL solutionAnnouncementKORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1AI SummaryKORU Medical Systems announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance to use its FreedomEDGE® infusion system to deliver PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneously for HER2-positive breast cancer. The filing is a key step in KORU’s plan to expand FreedomEDGE beyond immunoglobulin treatments into the oncology infusion center market. The company says subcutaneous delivery can speed drug administration, reduce patient chair time, and support a more efficient care model compared with intravenous infusions. Infusion centers still face nursing challenges such as complex workflows, long setup times, and physical discomfort for patients and staff. FreedomEDGE is designed to provide consistent, controlled large‑volume subcutaneous delivery while simplifying clinical workflows. KORU says the system could improve nursing satisfaction by reducing setup time and physical strain. The company anticipates entering the market after receiving 510(k) clearance.Read Announcement KORU Medical Systems FDA Events - Frequently Asked Questions Has KORU Medical Systems received FDA approval? As of now, KORU Medical Systems (KRMD) has not received any FDA approvals for its therapy in the last two years. What drugs has KORU Medical Systems submitted to the FDA? In the past two years, KORU Medical Systems (KRMD) has reported FDA regulatory activity for FreedomEdge. What is the most recent FDA event for KORU Medical Systems? The most recent FDA-related event for KORU Medical Systems occurred on December 30, 2025, involving FreedomEdge. The update was categorized as "Provided Update," with the company reporting: "KORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1" What conditions do KORU Medical Systems' current drugs treat? Currently, KORU Medical Systems has one therapy (FreedomEdge) targeting the following condition: Infusion system to deliver pegcetacoplan 20 mL solution. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AbCellera Biologics FDA EventsAquestive Therapeutics FDA EventsHemab Therapeutics FDA EventsAdherex Technologies FDA EventsMIRA Pharmaceuticals FDA EventsNeuroOne Medical Technologies FDA EventsQuince Therapeutics FDA EventsSol-Gel Technologies FDA EventsAbbVie FDA EventsBristol Myers Squibb FDA EventsNuvation Bio FDA EventsAbeona Therapeutics FDA EventsArtelo Biosciences FDA EventsBiogen FDA EventsFate 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 Delcath Systems FDA Events Brainsway FDA Events NeuroPace FDA Events Tactile Systems Technology FDA Events Sight Sciences FDA Events ClearPoint Neuro FDA Events Mobia Medical FDA Events Avita Medical FDA Events Orchestra BioMed FDA Events Profound Medical FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:KRMD last updated on 12/31/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our Partners$40,000,000,000,000The national debt just hit 40 trillion dollars, and the U.S. now spends more on interest payments than on its ...American Alternative | Sponsored“Elon’s nightmare” could fund your retirementMarc Chaikin, the 60 year Wall Street veteran whose Chaikin Money Flow indicator sits on every Bloomberg termi...Chaikin Analytics | SponsoredYou’ve never seen anything like this beforeFor centuries, families like the Rothschilds, Morgans, and Rockefellers have quietly used one overlooked type ...Porter & Company | SponsoredBank of America: 'Digital Dollar Inevitable'Bank of America just revealed your expiration date. In their Bloomberg interview, they didn't just predict the...Decentralized Masters | SponsoredMy top 3 AI picks for the next decadeAlexander Green bought Apple in 1996, recommended Nvidia at a split-adjusted 66 cents in 2004, and picked up A...The Oxford Club | SponsoredTrump goes "all-in" on Grand Canyon energy breakthroughA drilling crew near the Grand Canyon uncovered a clean energy well producing nearly eight times the output of...Behind the Markets | SponsoredA “bloodbath” Is ComingReports suggest some Silicon Valley billionaires are stockpiling gold, guns, and gas masks - or leaving the co...TradeSmith | SponsoredHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - b...Stansberry Research | 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 KORU Medical Systems, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share KORU Medical Systems With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access 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.
Provided Update - December 30,2025Provided Update Drug: FreedomEdgeAnnounced Date: December 30, 2025Indication: Infusion system to deliver pegcetacoplan 20 mL solutionAnnouncementKORU Medical Systems, Inc announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE® infusion system to subcutaneously administer PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer.1AI SummaryKORU Medical Systems announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance to use its FreedomEDGE® infusion system to deliver PHESGO® (pertuzumab/trastuzumab/hyaluronidase-zzxf) subcutaneously for HER2-positive breast cancer. The filing is a key step in KORU’s plan to expand FreedomEDGE beyond immunoglobulin treatments into the oncology infusion center market. The company says subcutaneous delivery can speed drug administration, reduce patient chair time, and support a more efficient care model compared with intravenous infusions. Infusion centers still face nursing challenges such as complex workflows, long setup times, and physical discomfort for patients and staff. FreedomEDGE is designed to provide consistent, controlled large‑volume subcutaneous delivery while simplifying clinical workflows. KORU says the system could improve nursing satisfaction by reducing setup time and physical strain. The company anticipates entering the market after receiving 510(k) clearance.Read Announcement
Free KRMD Stock Alerts