Liminatus Pharma (LIMN) FDA Approvals $0.14 -0.01 (-6.60%) Closing price 04:00 PM EasternExtended Trading$0.13 -0.01 (-5.71%) As of 07:59 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 EventsHeadlinesSEC FilingsTrendsBuy This Stock Liminatus Pharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Liminatus Pharma (LIMN). Over the past two years, Liminatus Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IBA101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. IBA101 FDA Regulatory Events IBA101 is a drug developed by Liminatus Pharma for the following indication: next-generation CD47 antibody. 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. Initiation - March 17,2026Initiation Phase 1Drug: IBA101Announced Date: March 17, 2026Indication: next-generation CD47 antibodyAnnouncementLiminatus announced plans to initiate a Phase 1 clinical trial evaluating IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and complement established immuno-oncology therapies.AI SummaryLiminatus plans to start a Phase 1 clinical trial of IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and work alongside PD-1/PD-L1 checkpoint inhibitors. IBA101 targets the CD47 "don't-eat-me" signal that helps tumor cells evade macrophages. By boosting macrophage-mediated tumor clearance and improving antigen presentation, the drug aims to increase the depth and durability of responses to established immuno-oncology treatments in solid tumors. The planned Phase 1 is a seamless program beginning with monotherapy dose escalation to assess safety, tolerability and pharmacokinetics, then moving into combination cohorts with PD-1/PD-L1 therapies under the same protocol. Lung cancer is the initial focus. The study, led by Dr. Se-Hoon Lee, will include translational analyses to measure immune activity and identify markers associated with benefit. Liminatus expects to complete manufacturing, nonclinical work and regulatory planning before advancing the program.Read AnnouncementProvided Update - June 24,2025Provided Update Drug: IBA101Announced Date: June 24, 2025Indication: next-generation CD47 antibodyAnnouncementLiminatus announced that it has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates.AI SummaryLiminatus Pharma is preparing to redefine the immune-oncology landscape with its novel CD47 checkpoint inhibitor, IBA101. Unlike earlier candidates, IBA101 is engineered to avoid side effects such as anemia and thrombocytopenia by sparing red blood cells and platelets. This is achieved through precise epitope selection and Fc engineering, allowing for higher dosing levels and potentially a more effective anti‑tumor response. Preclinical studies in non‑human primates have shown promising safety, with no significant reductions in hemoglobin or platelet counts. By blocking the “don’t‑eat‑me” signal on tumor cells, IBA101 reactivates the body’s immune clearance system, which may lead to more robust immune responses against cancer. Liminatus’ progress marks an important step toward safer and more potent immunotherapy, with upcoming clinical trials planned in both the United States and Korea.Read Announcement Liminatus Pharma FDA Events - Frequently Asked Questions Has Liminatus Pharma received FDA approval? As of now, Liminatus Pharma (LIMN) has not received any FDA approvals for its therapy in the last two years. What drugs has Liminatus Pharma submitted to the FDA? In the past two years, Liminatus Pharma (LIMN) has reported FDA regulatory activity for IBA101. What is the most recent FDA event for Liminatus Pharma? The most recent FDA-related event for Liminatus Pharma occurred on March 17, 2026, involving IBA101. The update was categorized as "Initiation," with the company reporting: "Liminatus announced plans to initiate a Phase 1 clinical trial evaluating IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and complement established immuno-oncology therapies." What conditions do Liminatus Pharma's current drugs treat? Currently, Liminatus Pharma has one therapy (IBA101) targeting the following condition: next-generation CD47 antibody. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Fate Therapeutics FDA EventsLantheus FDA EventsAgenus FDA EventsBiomea Fusion FDA EventsMiNK Therapeutics FDA EventsRigel Pharmaceuticals FDA EventsBristol Myers Squibb FDA EventsAligos Therapeutics FDA EventsAnnexon FDA EventsAlterity Therapeutics FDA EventsCullinan Therapeutics FDA EventsDefinium Therapeutics FDA EventsFreenome FDA EventsAthira Pharma FDA EventsNeurocrine Biosciences 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 Celularity FDA Events Novogen FDA Events Atossa Genetics FDA Events NeuroSense Therapeutics FDA Events Werewolf Therapeutics FDA Events Jasper Therapeutics FDA Events Marker Therapeutics FDA Events Quantum Biopharma FDA Events NextCure FDA Events NLS Pharmaceutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:LIMN last updated on 3/17/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - b...Stansberry Research | SponsoredTrump’s New Currency ResetTrump is launching a new $250 bill - but that may be a distraction. Behind the scenes, Executive Order 14241 i...Porter & Company | SponsoredAI insiders stockpile guns, gold & gas masksKeith Kaplan, CEO of TradeSmith, has spent more than $17 million studying AI since 2022. He says a major shift...TradeSmith | SponsoredWall Street is staring at the wrong AI tradeAnthropic just signed a 9.1 billion dollar, 20 year data center agreement covering 191 megawatts of capacity, ...The Oxford Club | SponsoredYour book is insideThe "Sucker's Bet" Most New Options Traders Fall For Most people who try options lose money the same way. ...Profits Run | SponsoredCODE RED: AI Meltdown Imminent?After correctly predicting the 2008 and 2020 stock market meltdowns, I believe this AI company is about to tri...Paradigm Press | SponsoredWho Really Gets Rich from IPOs?Peter Thiel turned a $500,000 stake in Meta into nearly $1 billion by investing eight years before its IPO. Tr...Weiss Ratings | Sponsored$100 for this… $500 for that. Here’s how to stop the bleeding todayRising costs are squeezing households nationwide. USA Today reports more families are moving in together, whil...Brownstone 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 Liminatus Pharma Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Liminatus Pharma 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.
Initiation - March 17,2026Initiation Phase 1Drug: IBA101Announced Date: March 17, 2026Indication: next-generation CD47 antibodyAnnouncementLiminatus announced plans to initiate a Phase 1 clinical trial evaluating IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and complement established immuno-oncology therapies.AI SummaryLiminatus plans to start a Phase 1 clinical trial of IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and work alongside PD-1/PD-L1 checkpoint inhibitors. IBA101 targets the CD47 "don't-eat-me" signal that helps tumor cells evade macrophages. By boosting macrophage-mediated tumor clearance and improving antigen presentation, the drug aims to increase the depth and durability of responses to established immuno-oncology treatments in solid tumors. The planned Phase 1 is a seamless program beginning with monotherapy dose escalation to assess safety, tolerability and pharmacokinetics, then moving into combination cohorts with PD-1/PD-L1 therapies under the same protocol. Lung cancer is the initial focus. The study, led by Dr. Se-Hoon Lee, will include translational analyses to measure immune activity and identify markers associated with benefit. Liminatus expects to complete manufacturing, nonclinical work and regulatory planning before advancing the program.Read Announcement
Provided Update - June 24,2025Provided Update Drug: IBA101Announced Date: June 24, 2025Indication: next-generation CD47 antibodyAnnouncementLiminatus announced that it has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates.AI SummaryLiminatus Pharma is preparing to redefine the immune-oncology landscape with its novel CD47 checkpoint inhibitor, IBA101. Unlike earlier candidates, IBA101 is engineered to avoid side effects such as anemia and thrombocytopenia by sparing red blood cells and platelets. This is achieved through precise epitope selection and Fc engineering, allowing for higher dosing levels and potentially a more effective anti‑tumor response. Preclinical studies in non‑human primates have shown promising safety, with no significant reductions in hemoglobin or platelet counts. By blocking the “don’t‑eat‑me” signal on tumor cells, IBA101 reactivates the body’s immune clearance system, which may lead to more robust immune responses against cancer. Liminatus’ progress marks an important step toward safer and more potent immunotherapy, with upcoming clinical trials planned in both the United States and Korea.Read Announcement
