TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq) by Orca Biosystems Inc.: new cellular therapy listing
TREGZI: new cellular therapy listing. Dated 127 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-11-03, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
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| 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 |
| Peer records CSV (1 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Product · Labeler · Pathway · Form · Listed · official source URL
- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-06-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Tue, 03 Nov 2026 18:09:00 GMT
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70 / 100 Launch Signal Score
- Prescription or biologic product.
- Brand or biologic launch.
What is the FdaNdcDirectoryPulse record for TREGZI?
TREGZI by Orca Biosystems Inc.: new cellular therapy listing (BLA) starting 2026-06-30.
How does TREGZI compare to other FdaNdcDirectoryPulse records?
It is 127 days old; check the official source for later updates before acting. Its Launch Signal Score of 70/100 puts it among the stronger signals in this feed.
TREGZI vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TREGZI | CELLULAR THERAPY | 2026-06-30 |
| ENZEEVU | HUMAN PRESCRIPTION DRUG | 2026-10-26 |
| Daptomycin | HUMAN PRESCRIPTION DRUG | 2026-10-22 |
| TechneLite | HUMAN PRESCRIPTION DRUG | 2026-10-21 |
Related records
FdaNdcDirectoryPulse: Biologic (BLA)
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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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.