MacroGenics, Inc. (MGNX), a clinical-stage biopharmaceutical company announced that the U. S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 2 LINNET study evaluating lorigerlimab in gynecologic cancer.
As per the terms of the clinical hold, no new patients will be enrolled in the LINNET study until the hold is lifted. But the current study participants may continue to receive the study drug.
To date, 41 study participants have been dosed at 6 mg/kg every 3 weeks across the platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) cohorts.
Notably, the study was also designed to enrol up to 20 patients with CCGC who have received at least one prior line of therapy.
The FDA's partial clinical hold was initiated following MacroGenics' recent notification to the FDA regarding safety events in the Linnet Trial, including 3 participants experiencing Grade 4 (life-threatening) events and 1 participant with a Grade 5 (fatal) event.
Following the news, MGNX is plunging 8.57% to $1.60.
Lorigerlimab is an investigational, bispecific DART molecule that targets PD-1 and CTLA-4 in patients with gynecologic cancers.
The LINNET study is evaluating lorigerlimab as monotherapy in a Simon two-stage trial in eligible patients with PROC who have received up to three prior lines of therapy. If a predefined activity threshold is met in the first stage based on approximately 20 patients, the study may expand to enrol an additional 20 patients.The primary endpoint is objective response rate (ORR), with multiple secondary endpoints.
The safety events that made the enrollment pause occurred across four patients and included,
-Grade 4 (Life-threatening ) thrombocytopenia, indicating a drop in platelets in 2 participants.
- Grade 4 Myocarditis, representing inflammation of the heart muscle, in 1 participant.
- Grade 4 Neutropenia and concurrent septic shock, indicating very low neutrophils for fighting infection and a critical drop in blood pressure due to excess infection in 1 participant, which led to a Grade 5 event (fatal).
Eric Risser, President and CEO said that "MacroGenics is fully committed to working closely with the FDA to resolve the partial clinical hold and we intend to resume study enrollment as soon as possible."
MGNX has traded between $0.99 and $2.78 in the last one year. The stock closed Monday's trade at $1.75, up 2.94%.
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