After partial clinical suspension by the FDA, MacroGenics stock price drops

Investing.com – MacroGenics Inc (NASDAQ:MGNX) stock dropped 7.4% in pre-market trading on Tuesday after the company announced that the FDA has implemented a partial clinical hold on its LINNET study of lorigerlimab in gynecologic cancer patients.

Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the FDA lifts the suspension. Current participants may continue to receive the investigational drug.

This action by the FDA follows MacroGenics’ recent notification of a temporary enrollment pause due to safety concerns. The safety events involved four patients, including two with grade 4 thrombocytopenia, one with grade 4 myocarditis, and one with grade 4 neutropenic sepsis leading to a grade 5 event. To date, 41 participants in the platinum-resistant ovarian and clear cell gynecologic cancer cohorts have received 6 mg/kg every three weeks.

“At MacroGenics, patient safety is our top priority,” said President and CEO Eric Risser. “We are fully committed to working closely with the FDA to address the partial clinical hold, and we plan to resume enrollment as soon as possible.”

The LINNET study is evaluating lorigerlimab as a monotherapy in eligible patients with platinum-resistant ovarian cancer who have received up to three prior lines of therapy. The study also plans to enroll up to 20 patients with clear cell gynecologic cancer who have received at least one prior line of treatment. The primary endpoint is objective response rate. Lorigerlimab is an investigational bispecific DART molecule targeting PD-1 and CTLA-4.

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