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
lorigerlimab and vobramitamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
lorigerlimab - FDA Regulatory Timeline and 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:
- 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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vobramitamab duocarmazine - FDA Regulatory Timeline and Events
vobramitamab duocarmazine is a drug developed by MacroGenics for the following indication: In metastatic castration-resistant prostate cancer (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:
- vobramitamab duocarmazine
- Announced Date:
- September 8, 2024
- Indication:
- In metastatic castration-resistant prostate cancer (mCRPC
Announcement
MacroGenics, Inc. announced a poster presentation relating to Phase 2 data of vobramitamab duocarmazine in metastatic castration-resistant prostate cancer (mCRPC) at the European Society for Medical Oncology (ESMO) Congress, taking place in Barcelona, Spain from September 13-17, 2024.
AI Summary
MacroGenics, Inc. announced that it will showcase updated Phase 2 data for its antibody-drug conjugate, vobramitamab duocarmazine, in metastatic castration-resistant prostate cancer (mCRPC) at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain. The poster, titled “TAMARACK: Randomized Phase 2 trial of the B7-H3 targeting antibody-drug conjugate (ADC) vobra duo in mCRPC,” will be available on September 15, 2024, during the session running from 9:00 a.m. to 5:00 p.m. CEST. The data presented will be based on a July 9, 2024, data cut-off and will include updated safety and efficacy information. Key results include insights on the study’s primary endpoint, the landmark 6-month radiographic progression-free survival (rPFS), providing new perspectives on the treatment’s performance in mCRPC patients.
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