MACROGENICS INC 8-K

What Happened
MacroGenics, Inc. announced on April 8, 2026 (Form 8-K) that the U.S. Food and Drug Administration has removed the partial clinical hold on its Phase 2 LINNET study of lorigerlimab. Lorigerlimab is an investigational bispecific DART® molecule that targets PD‑1 and CTLA‑4 and is being studied in patients with gynecologic cancers. The company issued a press release about the development (attached as Exhibit 99.1 to the 8‑K).

Key Details

• Filing date: April 8, 2026 (Form 8‑K reporting “Other Events,” Item 8.01).
• Drug: lorigerlimab — a bispecific DART® molecule targeting PD‑1 and CTLA‑4.
• Study: Phase 2 LINNET study in patients with gynecologic cancers; the FDA removed a partial clinical hold allowing study activities to proceed.
• Press release: dated April 8, 2026 and included as Exhibit 99.1 to the 8‑K.

Why It Matters
Removal of a partial clinical hold is a regulatory milestone that allows MacroGenics to resume or continue clinical activities for the LINNET study, which can affect trial timelines and downstream data-read milestones. For investors, this reduces a regulatory obstacle tied to lorigerlimab’s development in gynecologic cancers, but the drug remains investigational and future safety and efficacy results are still required before any approval or commercialization can occur.