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  2. ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants
ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants

BiotechTV - News · Dec 7, 2025

Orca Bio's Orca T therapy aims to replace stem cell transplants for blood cancer, using regulatory T-cells to prevent GVHD. PDUFA is April 6.

Orca Bio's Business Model Replaces a Medical Procedure, Not Just a Drug

Orca Bio's strategy is not to sell a standalone product, but to replace the entire conventional stem cell transplant procedure. They integrate their manufacturing process directly into the existing patient and donor workflow, leveraging established infrastructure like the National Marrow Donor Program to deliver a superior alternative.

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants thumbnail

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants

BiotechTV - News·2 months ago

Orca Bio Expands Market by Targeting Older, Frailer Patients

Orca Bio's initial trials focused on younger patients who can withstand intense chemotherapy. Now, they are strategically expanding their addressable market by demonstrating Orca T's effectiveness with reduced-intensity conditioning. This makes the curative therapy safer and accessible to a larger population of older or frailer patients.

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants thumbnail

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants

BiotechTV - News·2 months ago

Orca Bio's 72-Hour 'Vein-to-Vein' Window Creates a Logistical Moat

Unlike cryopreserved cell therapies, Orca Bio's fresh-cell treatment operates on a strict 72-hour timeline from donor to patient. This complex logistical requirement, demanding tight coordination with donor centers and hospitals, serves as a significant operational barrier to entry for potential competitors, creating a durable advantage.

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants thumbnail

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants

BiotechTV - News·2 months ago

Orca Bio's Platform Aims to Solve Broader Cell Therapy Challenges

Beyond its lead product Orca T for matched donors, the company is building a broader platform. Its Orca Q program addresses mismatched donors, expanding the patient pool. Furthermore, collaborations to combine Orca T with allogeneic CAR-T therapies position the technology as a foundational solution for overcoming key hurdles in the wider cell therapy field.

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants thumbnail

ASH 2025: Orca Bio has an April 6th PDUFA date from FDA for its cell therapy product, Orca-T, that aims to solve the problem of treatment-related toxicities that come with stem cell transplants

BiotechTV - News·2 months ago