New PDUFA Target Action Date of July 6, 2026 allows FDA additional time to complete its review

Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, 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. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.

The extension follows Orca Bio's recent submission of updated chemistry, manufacturing and controls (CMC) information in response to requests from the FDA as part of the standard review process. The FDA classified the submission as a Major Amendment (MA) to the BLA, which extends the review by three months. Importantly, the FDA has not requested any additional clinical data. Orca Bio believes that the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA.

"We appreciate the frequent engagement with the FDA throughout the review process,” said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. “Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible.”

The BLA for Orca-T was granted Priority Review by the FDA and Orca-T previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation.

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA).

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.

Trademarks or registered trademarks used in this press release are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260401769347/en/

"We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible.”