The U.S. Food and Drug Administration removed the partial clinical hold on MacroGenics, Inc.’s Phase 2 LINNET study of lorigerlimab on April 08 2026, allowing new participants to be enrolled under a revised protocol that incorporates additional risk‑mitigation measures for hematologic and cardiac toxicities.
The hold was originally placed on February 23 2026 after four serious safety events were reported: two cases of grade 4 thrombocytopenia, one case of grade 4 myocarditis, and one case of grade 4 neutropenia accompanied by septic shock that resulted in a fatality. The revised protocol addresses these concerns with enhanced monitoring and dose‑adjustment guidelines.
At the time of the lift, 41 patients had already been dosed in the LINNET study, with a target enrollment of approximately 60. Resuming enrollment will enable the collection of additional efficacy and safety data, positioning the company to deliver a mid‑2026 program update on lorigerlimab’s clinical trajectory.
MacroGenics reported Q4 2025 revenue of $41.23 million, beating consensus estimates of $27.81 million, while earnings per share were –$0.22 versus the expected –$0.18. The revenue beat reflects higher sales of the company’s other pipeline products, whereas the EPS miss indicates that operating costs outpaced revenue growth. The company’s cash balance was $189.9 million as of December 31 2025, providing a runway into late 2027.
President and CEO Eric Risser said, “We are grateful for the productive interaction with the reviewers at the FDA’s Office of Oncologic Diseases, as well as the diligent efforts of the MacroGenics team to provide a rapid and comprehensive response to the FDA.” He added, “With the partial clinical hold lifted, we intend to resume enrollment of new study participants in the ongoing LINNET study and we remain on track to provide a mid‑year clinical update on the program.”
Beyond lorigerlimab, MacroGenics continues to develop antibody‑drug conjugates MGC026, MGC028, and MGC030 and maintains collaborations with Gilead, Sanofi, and Incyte. The lift de‑risks the company’s most advanced proprietary program and supports its strategy to advance the bispecific pipeline while maintaining rigorous safety oversight.
Investors viewed the lift as a de‑risking event, reflecting confidence in the program’s progress and the company’s financial stability, as evidenced by the recent earnings beat and robust cash position.
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