Adicet Bio Completes Last Patient Visit for prula-cel SLE Study; Topline Data Due September 2026
ACET sits 45% above its 52-week low of $6.01.
Summary
Adicet Bio completed the last patient visit for its prula-cel SLE study and expects topline data in September 2026. The company also outlined next steps for ADI-212 and its in vivo CAR-T platform.
Key Events · Product Development and Regulatory · ACET
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Prula-cel SLE Study Completes Enrollment
The last patient visit has been completed for the planned Phase 1 analysis of prula-cel in SLE with or without lupus nephritis. Topline data are expected in September 2026.
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Data Readout Scope
The planned analysis includes 22 SLE patients with a minimum of 6 months of follow-up, including 13 patients with at least 12 months of follow-up.
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Registrational Path in Development
A potential registrational trial design is in development following FDA interaction; additional information is expected with the upcoming clinical update.
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ADI-212 Phase 1 to Start Q4 2026
The FDA has cleared the IND for ADI-212 in mCRPC; Phase 1 enrollment is expected to initiate in Q4 2026.
Analysis · ACET · Life Sciences
The last patient visit for the planned Phase 1 analysis of prula-cel in systemic lupus erythematosus has been completed, with topline data expected this month. The readout will cover 22 patients with at least six months of follow-up, including 13 with at least 12 months. As the company's lead asset, these data will shape the registrational path. FDA clearance of the ADI-212 IND was also confirmed, with plans to start that Phase 1 study in Q4 2026, plus a first in vivo CAR-T candidate entering the clinic in 2H 2027. The near-term catalyst is the prula-cel data, which could materially reprice the stock given the company's roughly $81 million market cap.
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At the time of this filing, ACET was trading at $8.72 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $81.4M. The 52-week trading range was $6.01 to $17.44. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.