MacroGenics, Inc. (MGNX), a clinical-stage biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has removed the partial clinical hold on the firm's Phase 2 LINNET study of Lorigerlimab in ovarian cancer or clear cell gynaecologic cancer .
The LINNET study is evaluating Lorigerlimab, a bispecific DART molecule, in approximately 60 eligible patients with either platinum-resistant ovarian cancer or clear cell gynaecologic cancer who have received one or more prior lines of therapy.
The FDA's partial clinical hold was initiated following MacroGenic's notification of a temporary pause in enrollment of new participants in the LINNET trial due to Grade 4 and Grade 5 safety events reported across four patients, including a death.
Following that, MacroGenics worked closely with the FDA to resolve the hold.
To date, 41 study participants have been dosed in the LINNET study, and over 300 study participants have been dosed across all previous Lorigerlimab Phase 1 and Phase 2 clinical studies.
Now that the hold has been lifted, MacroGenics plans to resume enrollment in the clinical study and remains on track to provide a mid-2026 program update.
Meanwhile, new participants will be enrolled under a revised protocol that includes additional risk-mitigation measures to address potential hematologic and cardiac toxicities.
"We are grateful for the productive interaction with the reviewers at the FDA's Office of Oncologic Diseases", said Eric Risser, President and Chief Executive Officer of MacroGenics.
Total revenue for 2025 slipped to $149.50 million from $149.96 million in the prior year, which included contract manufacturing revenue.
Net loss for the full year widened to $74.62 million or $1.18 per share from $66.96 million or $1.07 per share in the prior year.
As of December 31,025, the firm had a cash, cash equivalents and marketable securities balance of $189.91 million and is expected to support its cash runway into late 2027.
MGNX has traded between $1.02 and $3.54 in the last year. The stock closed Wednesday's trade at $3.45, up 2.99%.
In the after-hours market, MGNX is down 1.45% at $3.40.
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