Adicet Bio

The FDA has approved the Investigational New Drug (IND) application for ADI-212 from Adicet Bio, a gene‑edited cell therapy targeting prostate-specific membrane antigen (PSMA) that combines a CAR binder with membrane-anchored IL-12 and CRISPR/Cas9-mediated disruption of a Mediator complex subunit. Patient enrollment in the planned phase 1 study is expected to begin in the fourth quarter of 2026. The approval allows Adicet to proceed with human clinical trials and complements the company’s portfolio of allogeneic gamma-delta T-cell therapies and in‑vivo CAR‑T programs. » Altro su de.investing.com

Adicet Bio plans to publish this quarter what it says is its largest dataset to date for an allogeneic cell therapy in lupus nephritis and SLE (22 patients, 13 with ≥12 months’ follow-up). Lead candidate ADI-001 showed complete B‑cell depletion and a consistent immune reset, with no reports of high‑grade ICANS. Management has held talks with the FDA and intends to publish the agency’s feedback together with the clinical data; single‑arm approval studies of 35–90 patients are under discussion, primarily for lupus nephritis. Adicet emphasizes the practical advantages of the off‑the‑shelf allogeneic approach and sees an initial target market among treatment‑refractory LN patients. » Altro su de.investing.com

Adicet Bio reported EPS of -$2.94 per share for the quarter ended December 31, 2025, versus -$5.12 in the year-ago quarter. EPS for the full year was -$16.95 per share, after -$21.28 in the prior year. The report was published on March 12, 2026. » Altro su finanzen.net