RegulatoryCompany release

Adicet's ADI-212 wins FDA IND clearance and Fast Track; lupus pivotal start-up advances

🇺🇸 Adicet Bio, Inc. (ACET) · Thu 05 Nov 2026

Adicet Bio reports Q3 2026 results, with ADI-212 cleared for prostate cancer and prula-cel's lupus nephritis pivotal study in start-up, alongside $100.9 million in cash.

Adicet Bio reported its third-quarter 2026 results on 5 November, highlighting regulatory progress for ADI-212 in oncology and for prula-cel in autoimmune disease.

The US Food and Drug Administration cleared the investigational new drug (IND) application for ADI-212 in metastatic castration-resistant prostate cancer in August. In September, the agency granted the programme Fast Track Designation. Fast Track is a US designation intended to speed development of products addressing serious conditions with unmet need, and it allows more frequent interaction with the FDA.

On prula-cel, the company said Phase 1 data in lupus showed durable responses. No Grade 2-or-higher events were exceeded: it reported no Grade above 2 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD). Start-up activities for a pivotal study in lupus nephritis are under way.

Adicet plans to meet the FDA in the fourth quarter of 2026 to discuss expanding the pivotal programme to cover lupus without nephritis. The company reported cash of $100.9 million, which it said should fund operations into the second half of 2027.

What it means for your team

  • The Q4 2026 FDA meeting on extending prula-cel's pivotal programme to lupus without nephritis is the next regulatory milestone to watch.
  • Safety reporting of no CRS, ICANS or GvHD above Grade 2 in lupus Phase 1 data will be relevant to pharmacovigilance teams tracking cell-therapy risk profiles in autoimmune indications.
  • Fast Track for ADI-212 signals potential for closer FDA dialogue, though the source gives no detail on timelines or pivotal plans in prostate cancer.
  • Funding into 2H 2027 frames the company's runway for the planned development steps.

Company's press release (SEC filing): Adicet Bio, Inc. ↗

Article written by VigiEye from the official source (Adicet Bio, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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