Drugs / Lorigerlimab
Lorigerlimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | uterine adnexa cancer | 2026-02-23 | “FDA has placed partial clinical hold on LINNET study of lorigerlimab in gynecologic cancer” macrogenics.com ↗ |
Trials 9
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | MacroGenics | Results MacroGenics Reports First Quarter 2026 Financial Results and Highlights Business Transformation macrogenics.com ↗
Of the 16 evaluable patients with CCGC, 4 (25%) had objective responses, including 4 with confirmed partial responses (PR), of which 1 patient subsequently had an unconfirmed complete response (CR). |
| 2026-04-08 | MacroGenics | Regulatory FDA Removes Partial Clinical Hold on MacroGenics’ LINNET Study macrogenics.com ↗ |
| 2026-02-23 | MacroGenics | Regulatory MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial macrogenics.com ↗ |
| 2023-02-13 | MacroGenics | Results MacroGenics Announces Preliminary Clinical Results from Single Arm Study of Lorigerlimab in Patients with Metastatic Castration-Resistant Prostate Cancer to be Presented at ASCO Genitourinary Cancers Symposium macrogenics.com ↗
Twelve of 42 patients (28.6%) in metastatic castration-resistant prostate cancer (mCRPC) cohort achieved ≥ 50% prostate-specific antigen (PSA) reduction (PSA50), including 9 (21.4%) who achieved ≥ 90% PSA reduction (PSA90) |
All press releases naming this drug 4 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lorigerlimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07223567 ↗ |
| Known as | AEX-1344 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095278 ↗ |
| Known as | MGD-019 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095278 ↗ |
| Modality | Protein / enzyme biologic | “Bispecific DART protein” NCT03761017 ↗ |
| Route | Intravenous | “administered IV” NCT03761017 ↗ |