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(RTTNews) - Adicet Bio, Inc. (ACET), on Thursday announced that its investigational therapy ADI-001 has been granted Fast Track Designation by the FDA for the treatment of systemic sclerosis or SSc.

ADI-001 is an allogeneic gamma delta chimeric antigen receptor or CAR T cell therapy targeting CD20, and is currently under development for autoimmune diseases.

Fast Track designation facilitates the expedited development and review of ADI-001, which is already being evaluated in a Phase 1 study for lupus nephritis or LN. The Designation might help in accelerated approval, aiming to address the significant unmet medical need in systemic sclerosis and other autoimmune diseases.

The company plans to initiate patient enrollment in SLE, SSc, idiopathic inflammatory myopathy or IIM, and stiff person syndrome or SPS trials in the second quarter of 2025, with ANCA-associated vasculitis or AAV enrollment expected to follow later in the year.

Adicet Bio's ADI-001 has shown promising results in its early-stage trials, with B-cell targeting and depletion, which could have a transformative impact on the treatment of these serious autoimmune conditions.

ACET closed Wednesday's (Feb.26 2025) trading at $0.90 up by 1.04 percent. In premarket trading Thursday the stock is up by 14.15 percent at $1.03 on the Nasdaq.

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