MacroGenics (MGNX) FDA Approvals $4.08 -0.12 (-2.74%) As of 01:35 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest MacroGenics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by MacroGenics (MGNX). Over the past two years, MacroGenics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as lorigerlimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Lorigerlimab FDA Regulatory Events Lorigerlimab is a drug developed by MacroGenics for the following indication: In patients with mCRPC. 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. Clinical hold Removed - April 8,2026Clinical Hold Removed Drug: lorigerlimabAnnounced Date: April 8, 2026Indication: In patients with mCRPCAnnouncementMacroGenics, Inc. announced that the U. S. Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4.AI SummaryMacroGenics, Inc. announced that the U.S. Food and Drug Administration has removed a partial clinical hold on the company's Phase 2 LINNET study of lorigerlimab. This decision allows MacroGenics to resume important clinical work and progress the program. The company plans to resume enrollment in the trial of lorigerlimab in gynecologic cancers and says it is on track to provide a program update in mid-2026. Resuming enrollment means patients can again be enrolled, and data collection will continue toward planned milestones. Lorigerlimab is an investigational, bispecific DART® molecule that targets two immune checkpoints, PD‑1 and CTLA‑4, aiming to boost anti‑tumor immune response. The LINNET study is a Phase 2 trial testing its safety and activity in gynecologic cancers, and MacroGenics will proceed under regulatory oversight as the study restarts.Read AnnouncementProvided Update - March 20,2025Provided Update Drug: lorigerlimabAnnounced Date: March 20, 2025Indication: In patients with mCRPCAnnouncementMacroGenics, Inc. provided an update on its recent corporate progressAI SummaryMacroGenics, Inc. recently updated stakeholders on its corporate progress. The company announced the full enrollment of the LORIKEET Phase 2 study, which is testing lorigerlimab combined with docetaxel in patients with metastatic castration-resistant prostate cancer. In addition, MacroGenics is set to start the LINNET Phase 2 trial to evaluate lorigerlimab as a single treatment in patients with platinum-resistant ovarian cancer and clear cell gynecologic cancer, conditions where treatment options are limited. The company is also advancing its pipeline of antibody-drug conjugates that use novel topoisomerase I inhibitor-based payloads, including candidates MGC026, MGC028, and the preclinical MGC030. Lastly, MacroGenics is discontinuing its internal development of vobra duo and will explore potential partnering options for the program. The company ended 2024 with strong financials and a cash runway extended into the second half of 2026.Read Announcement MacroGenics FDA Events - Frequently Asked Questions Has MacroGenics received FDA approval? As of now, MacroGenics (MGNX) has not received any FDA approvals for its therapy in the last two years. What drugs has MacroGenics submitted to the FDA? In the past two years, MacroGenics (MGNX) has reported FDA regulatory activity for lorigerlimab. What is the most recent FDA event for MacroGenics? The most recent FDA-related event for MacroGenics occurred on April 8, 2026, involving lorigerlimab. The update was categorized as "Clinical hold Removed," with the company reporting: "MacroGenics, Inc. announced that the U. S. Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4." What conditions do MacroGenics' current drugs treat? Currently, MacroGenics has one therapy (lorigerlimab) targeting the following condition: In patients with mCRPC. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Arrowhead Pharmaceuticals FDA EventsBioVie FDA EventsBlossomHill Therapeutics FDA EventsConnect Biopharma FDA EventsCogent Biosciences FDA EventsErnexa Therapeutics FDA EventsGT Biopharma FDA EventsOcular Therapeutix FDA EventsPulse Biosciences FDA EventsRocket Pharmaceuticals FDA EventsSummit Therapeutics FDA EventsVera Therapeutics FDA EventsNuvation Bio FDA EventsAkebia Therapeutics FDA EventsBioNTech 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 Solid Biosciences FDA Events Avalo Therapeutics FDA Events Sana Biotechnology FDA Events Arbutus Biopharma FDA Events Sensei Biotherapeutics FDA Events Lexicon Pharmaceuticals FDA Events Geron FDA Events WAVE Life Sciences FDA Events Candel Therapeutics FDA Events Olema Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:MGNX last updated on 4/9/2026 by MarketBeat.com Staff. 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Clinical hold Removed - April 8,2026Clinical Hold Removed Drug: lorigerlimabAnnounced Date: April 8, 2026Indication: In patients with mCRPCAnnouncementMacroGenics, Inc. announced that the U. S. Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4.AI SummaryMacroGenics, Inc. announced that the U.S. Food and Drug Administration has removed a partial clinical hold on the company's Phase 2 LINNET study of lorigerlimab. This decision allows MacroGenics to resume important clinical work and progress the program. The company plans to resume enrollment in the trial of lorigerlimab in gynecologic cancers and says it is on track to provide a program update in mid-2026. Resuming enrollment means patients can again be enrolled, and data collection will continue toward planned milestones. Lorigerlimab is an investigational, bispecific DART® molecule that targets two immune checkpoints, PD‑1 and CTLA‑4, aiming to boost anti‑tumor immune response. The LINNET study is a Phase 2 trial testing its safety and activity in gynecologic cancers, and MacroGenics will proceed under regulatory oversight as the study restarts.Read Announcement
Provided Update - March 20,2025Provided Update Drug: lorigerlimabAnnounced Date: March 20, 2025Indication: In patients with mCRPCAnnouncementMacroGenics, Inc. provided an update on its recent corporate progressAI SummaryMacroGenics, Inc. recently updated stakeholders on its corporate progress. The company announced the full enrollment of the LORIKEET Phase 2 study, which is testing lorigerlimab combined with docetaxel in patients with metastatic castration-resistant prostate cancer. In addition, MacroGenics is set to start the LINNET Phase 2 trial to evaluate lorigerlimab as a single treatment in patients with platinum-resistant ovarian cancer and clear cell gynecologic cancer, conditions where treatment options are limited. The company is also advancing its pipeline of antibody-drug conjugates that use novel topoisomerase I inhibitor-based payloads, including candidates MGC026, MGC028, and the preclinical MGC030. Lastly, MacroGenics is discontinuing its internal development of vobra duo and will explore potential partnering options for the program. The company ended 2024 with strong financials and a cash runway extended into the second half of 2026.Read Announcement
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