Adicet Bio Reports Promising Phase 1 Lupus Treatment Results, Plans Phase 2 FDA Talks

Adicet Bio has reported promising Phase 1 results for its ADI-001 therapy targeting lupus nephritis (LN) and systemic lupus erythematosus (SLE), showing 100% renal response among seven patients and significant reductions in disease activity scores. The treatment demonstrated a favorable safety profile suitable for outpatient use, with no serious adverse events reported. The company plans to engage with the FDA in early 2026 to design a pivotal Phase 2 trial, anticipated to start in the second quarter of 2026. Despite these clinical advancements, Adicet Bio faces financial challenges, including no current revenue and ongoing losses, which have led some analysts to rate the stock as underperform. To support its development efforts, Adicet Bio has launched an $80 million securities offering priced at $1.00 per share, expected to close in October 2025. This funding will likely aid in advancing their autoimmune disease treatment pipeline and clinical trials.