# TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) by Orca Biosystems Inc.: new cellular therapy listing

**Launch Signal Score:** 70/100

| Field | Value |
|---|---|
| Product | TREGZI |
| Generic name | allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq |
| NDC | 85866-223 |
| Labeler | Orca Biosystems Inc. |
| Product type | CELLULAR THERAPY |
| Approval pathway | BLA |
| Application number | BLA125868 |
| Dosage form | KIT |
| Marketing start | 2026-06-30 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=85866-223). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.