This 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
MGC030 and lorigerlimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
MGC030 FDA Regulatory Events
MGC030 is a drug developed by MacroGenics for the following indication: In Patients With Advanced Solid Tumors.
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.
- Drug:
- MGC030
- Announced Date:
- October 15, 2026
- Indication:
- In Patients With Advanced Solid Tumors
Announcement
MacroGenics, Inc announced that the first patient has been dosed in the Phase 1 study of MGC030, a first-in-class antibody-drug conjugate (ADC) directed against an undisclosed target, in patients with advanced solid tumors.
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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.
- Drug:
- lorigerlimab
- Announced Date:
- April 8, 2026
- Indication:
- In patients with mCRPC
Announcement
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.
AI Summary
MacroGenics, 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- Drug:
- lorigerlimab
- Announced Date:
- March 20, 2025
- Indication:
- In patients with mCRPC
Announcement
MacroGenics, Inc. provided an update on its recent corporate progress
AI Summary
MacroGenics, 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.
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