Drugs / Orca-T
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | hematopoietic and lymphoid cell neoplasm | 2025-10-06 | “today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking approval for Orca-T” orcabio.com ↗ “The BLA submission for Orca-T is supported by positive results from the pivotal Phase 3 study, Precision-T (NCT04013685)” orcabio.com ↗ |
Trials 6
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | Orca Biosystems, Inc. | Regulatory Orca Bio’s TREGZI™ Receives U.S. FDA Approval as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies orcabio.com ↗ |
| 2026-04-01 | Orca Biosystems, Inc. | Regulatory Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic Malignancies orcabio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. |
| 2026-02-05 | Orca Biosystems, Inc. | Results Orca Bio Presents New Data at the 2026 Tandem Meetings of ASTCT® and CIBMTR® Reinforcing Orca-T® as a Durable, High-Precision Cell Therapy for Hematological Malignancies orcabio.com ↗
New retrospective analysis showed Orca-T with reduced intensity conditioning (RIC) demonstrated favorable OS, RFS and GRFS compared to PTCy |
| 2025-12-15 | Orca Biosystems, Inc. | Results Orca Bio Announces Orca-T® Phase 3 Data Published in Blood Demonstrate Significant Improvement in Survival Free from Chronic Graft versus Host Disease in Patients with Hematological Malignancies orcabio.com ↗
In the randomized Precision-T study, Orca-T plus single-agent tacrolimus (TAC) demonstrated a significant improvement in the primary endpoint of survival free from moderate-to-severe chronic graft versus host disease (cGFS) compared to alloHSCT plus tacrolimus/methotrexate (TAC/MTX). |
| 2025-12-08 | Orca Biosystems, Inc. | Results Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 67th American Society of Hematology Annual Meeting orcabio.com ↗ |
| 2025-12-06 | Orca Biosystems, Inc. | Results Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 67th American Society of Hematology Annual Meeting orcabio.com ↗
Patients aged 60-75 treated with Orca-T and a reduced intensity conditioning regimen (RIC) experienced low incidence of acute and chronic GvHD with low rates of disease relapse |
| 2025-11-03 | Orca Biosystems, Inc. | Results Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 67th American Society of Hematology Annual Meeting orcabio.com ↗
Orca-T Improves cGVHD-free Survival in Patients with a Broad Range of Demographic and Clinical Variables: Results of Randomized, Phase 3 Trial |
| 2025-10-06 | Orca Biosystems, Inc. | Regulatory Orca Bio Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Orca-T® to Treat Hematological Malignancies orcabio.com ↗
The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026. |
| 2025-03-17 | Orca Biosystems, Inc. | Results Orca Bio Announces Positive Results from the Pivotal Phase 3 Study of Investigational Orca-T® Compared to Allogeneic Stem Cell Transplant for the Treatment of Hematologic Malignancies orcabio.com ↗
In the randomized Precision-T study, Orca-T met the primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T. |
| 2025-02-12 | Orca Biosystems, Inc. | Results Orca Bio Presents Positive Phase 1 and 1b Data on Orca-T and Orca-Q at the 2025 Tandem Meetings of ASTCT® and CIBMTR® orcabio.com ↗
Three-year follow-up data from the Phase 1b trial of Orca-T demonstrating improved overall survival in AML, ALL and high-risk MDS patients compared to a conventional allogeneic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy)-based GvHD prophylaxis. |
| 2025-02-10 | Orca Biosystems, Inc. | Results Orca Bio’s Orca-T® Meets Primary Endpoint in the Pivotal Precision-T Phase 3 Clinical Study for Hematologic Malignancies orcabio.com ↗
The Precision-T study met the protocol-specified primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T versus alloHSCT. |
| 2024-12-08 | Orca Biosystems, Inc. | Results Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting orcabio.com ↗
The results of a three-year follow-up analysis with Orca-T plus single-agent tacrolimus (TAC) showed encouraging overall survival (OS) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). |
| 2024-05-23 | Orca Biosystems, Inc. | Results Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting orcabio.com ↗
At 12 months, results found relapse-free survival was 82.5% (95% CI: 65.0, 91.7) and non-relapse mortality was 0%. |
| 2024-04-11 | Orca Biosystems, Inc. | Results Orca Bio to Present Positive Clinical Data on Orca-T at the 50th Annual Meeting of the EBMT orcabio.com ↗
Preliminary data with Orca-T and RIC in patients with hematologic malignancies showed encouraging rates of relapse-free survival (77%). |
| 2024-02-23 | Orca Biosystems, Inc. | Results Orca Bio Presents Promising Data on Orca-T in Two Oral Presentations at the 2024 Tandem Meetings of ASTCT® and CIBMTR® orcabio.com ↗
Orca-T, Orca Bio’s lead investigational high-precision cell therapy, showed favorable rates of relapse-free survival, non-relapse mortality and overall survival when compared to a non-randomized, historical cohort of post-transplant cyclophosphamide (PTCy) in a retrospective analysis |
| 2023-12-09 | Orca Biosystems, Inc. | Results Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting orcabio.com ↗
Orca-T, Orca Bio’s lead investigational high-precision cell therapy, showed similar results in older patients undergoing myeloablative conditioning as seen in younger patients across disease control, non-relapse mortality and overall survival |
| 2023-02-16 | Orca Biosystems, Inc. | Results Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR orcabio.com ↗
Orca-T demonstrated high relapse-free survival in recipients with fully matched donors and early potential in patients with mismatched donors |
| 2022-12-10 | Orca Biosystems, Inc. | Results Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th Annual Meeting orcabio.com ↗
The data demonstrated a significant improvement in relapse-free survival (RFS) at one year with 87% in 71 patients who received Orca-T and busulfan, fludarabine, and thiotepa (BFT) conditioning. |
| 2022-11-03 | Orca Biosystems, Inc. | Results Orca Bio to Present Four Abstracts at the 64th American Society of Hematology Annual Meeting, Including Updated Relapse-Free Survival Data with Orca-T and the First Clinical Data for Orca-Q orcabio.com ↗
Specifically, an oral presentation will include new data on relapse-free survival with Orca Bio’s lead investigational high-precision cell therapy, Orca-T. |
| 2022-04-25 | Orca Biosystems, Inc. | Results Orca Bio Presents Positive Data Reinforcing Clinical Profile and Manufacturing Reliability of Orca-T at 2022 Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings orcabio.com ↗
These data from an expanded group of patients are very encouraging and demonstrate that Orca-T appears to improve survival while reducing GvHD. |
| 2021-12-11 | Orca Biosystems, Inc. | Results Positive Clinical Results from More than 100 Patients Treated with Orca Bio’s Lead Investigational High Precision Cell Therapy Presented at 63rd ASH Annual Meeting orcabio.com ↗
Pooled study results showed significantly higher graft-versus-host disease-free, relapse-free survival rates and improved overall survival rates with Orca-T compared to standard of care |
| 2021-02-11 | Orca Biosystems, Inc. | Results Orca Bio Announces Updated Orca-T Clinical Data Presented at the 2021 TCT (Transplantation & Cellular Therapy) Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR) orcabio.com ↗
today announced updated clinical data from its first-generation investigational therapy Orca-T, which was presented at the 2021 TCT Meetings of ASTCT and CIBMTR by Everett Meyer, MD, PhD, Assistant Professor of Medicine, Blood and Marrow Transplantation at Stanford University. |
| 2020-10-14 | Orca Biosystems, Inc. | Regulatory Orca Bio Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for Orca-T orcabio.com ↗
Orca Bio, a clinical-stage biotechnology company, today announced that the US Food and Drug Administration (FDA) has granted RMAT designation to Orca-T (NCT04013685). |
All press releases naming this drug 28 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Orca-T | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04013685 ↗ |
| Known as | Treg CD34+HSPC | “Treg CD34+HSPC (Orca-T)” NCT05507827 ↗ |
| Modality | Cell therapy | “It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons)” NCT04013685 ↗ |