libre de droit/iStock via Getty Images Adicet Bio ( NASDAQ: ACET ) on Wednesday said that the U.S. Food and Drug Administration has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis, sending shares up in early trade.
Adicet Bio ( ACET ) stock climbed +5.14% premarket to $1.43.
"The FDA’s decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease," said Chen Schor, President and Chief Executive Officer of Adicet Bio ( ACET ). “We plan to initiate our Phase 1 clinical study in lupus nephritis later this month," Adicet Bio ( ACET ) said. With clinical data for ADI-001 in non-Hodgkin’s lymphoma demonstrating CD19+ B-cell depletion that mirrors data by autologous alpha-beta CAR T in academic clinical studies in several autoimmune diseases, Adicet Bio ( ACET ) believes the company is positioned to expand its autoimmune program to address additional indications beyond lupus nephritis.
Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. Source: Press Release More on Adicet Bio Adicet Bio: Microcap With A High Risk To Reward Ratio Adicet Bio GAAP EPS of -$0.69 beats by $0.
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