ADI ‑ 212 — IND submission
3Q/2026
Regulatory filing for ADI ‑ 212 in metastatic castration ‑ resistant prostate cancer (mCPRC) planned for 3Q/2026; enrollment expected to begin 4Q/2026 pending regulatory clearanceSource filing
ACET biotech catalysts & pipeline
ADICET BIO INC · Data as of 2026-09-08
Upcoming catalysts
ADI-001 — FDA meeting
2Q/2026
U.S. Food and Drug Administration (FDA) interaction to inform potential pivotal trial design for prula-cel expected in 2Q/2026Source filing
ADI-001 — Topline data
H2 2026
Phase 1 enrollment is ongoing and we expect to provide a clinical update for this trial in LN, SLE and SSc patients in the first half of 2026, with a plan to provide an additional update in the second half of 2026.Source filing
ADI-212 — Initial data
H2 2026
The Company expects to share initial clinical data from the ADI-212 program in the second half of 2026, subject to regulatory clearance to proceed with a clinical trial.Source filing
ADI-212 — NDA/BLA submission
Q3 2026
We expect to submit a regulatory filing for ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2026.Source filing
ADI-001 — Topline data
Sep 2026
Prula-cel topline data from SLE patients with or without LN expected in September 2026.Source filing
ADI-001 — Interim data
Q4 2026
Clinical update in patients with systemic sclerosis expected in the fourth quarter of 2026.Source filing