Liminatus Pharma (LIMN) FDA Approvals $0.19 +0.00 (+1.55%) Closing price 05/19/2026 04:00 PM EasternExtended Trading$0.19 0.00 (-1.58%) As of 05/19/2026 07:50 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 FilingsShort InterestTrendsBuy 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 Alterity Therapeutics FDA EventsBlack Diamond Therapeutics FDA EventsJaguar Animal Health FDA EventsLipocine FDA EventsLantern Pharma FDA EventsZenas BioPharma FDA EventsMerck & Co., Inc. FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex 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 BioXcel Therapeutics FDA Events Rein Therapeutics FDA Events Lantern Pharma FDA Events Polyrizon FDA Events Briacell Therap FDA Events NeuroSense Therapeutics FDA Events Sensei Biotherapeutics FDA Events Tempest Therapeutics FDA Events Neuphoria Therapeutics FDA Events Werewolf Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:LIMN last updated on 3/17/2026 by MarketBeat.com Staff. 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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
