Adicet Bio, Inc. 8-K

What Happened

• On January 7, 2026, Adicet Bio, Inc. filed an 8‑K and issued a press release providing a corporate update. The company announced prulacabtagene leucel (prula‑cel, formerly ADI‑001) Phase 1 enrollment in autoimmune diseases doubled to over 20 patients as of December 31, 2025.
• Adicet said it reached alignment with the U.S. FDA to allow dosing patients with lupus nephritis and systemic lupus erythematosus (SLE) in the outpatient setting in ongoing and future trials, and plans to request an FDA meeting in Q2 2026 to inform potential Phase 2 pivotal trial design. The company also plans to submit a regulatory filing for ADI‑212 in metastatic castration‑resistant prostate cancer (mCRPC) in the first half of 2026.

Key Details

• prula‑cel Phase 1 enrollment: doubled to >20 patients (as of Dec 31, 2025).
• FDA agreement: outpatient dosing permitted for lupus nephritis and SLE patients in current/future trials.
• Regulatory timeline: Adicet plans an FDA meeting in Q2 2026 to discuss Phase 2 pivotal design for prula‑cel.
• ADI‑212: company plans a regulatory filing in mCRPC in H1 2026.
• Disclosure: press release furnished as Exhibit 99.1 to the Form 8‑K filed Jan 7, 2026; filing includes forward‑looking statements.

Why It Matters

• These items reflect clinical and regulatory progress: higher enrollment reduces early‑stage recruitment risk and the FDA agreement on outpatient dosing may simplify trial logistics and broaden patient access.
• Planned regulatory actions (FDA meeting for prula‑cel and ADI‑212 filing in H1 2026) set near‑term milestones investors can track for updates on program advancement and potential value drivers.
• The filing is informational—investors should watch for clinical data releases, regulatory meeting outcomes, and formal filings for concrete impact on the company’s prospects.