Ayrmid Ltd. Announces FDA Acceptance and Priority Review for Omidubicel for the Treatment of Severe Aplastic Anemia (SAA)

FDA assigns Prescription Drug User Fee Act (PDUFA) target date of December 10, 2025

LONDON–(BUSINESS WIRE)–Ayrmid Ltd. (“Ayrmid” or the “Company”), the parent company of Gamida Cell Inc., a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Company’s priority review application for omidubicel for the treatment of Severe Aplastic Anemia (“SAA”) and has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of December 10, 2025. The supplementary Biologics License Application (“sBLA”) submission is based on results of an investigator-sponsored study at the National Heart, Lung, and Blood Institute of the National Institutes of Health.

SAA is a rare, life-threatening hematologic disease characterized by bone marrow failure and low circulating blood cells. Hematopoietic stem cell transplant may be curative for SAA, but there is a significant unmet need for patients who do not have an available matched sibling donor.

Dr. Joe Wiley, Chairman and Chief Executive Officer of Ayrmid Ltd., commented: “Priority review of omidubicel brings us closer to being able to provide a breakthrough orphan, potentially curative treatment for Severe Aplastic Anemia (“SAA”). We have the commercial and medical infrastructure in place to launch this therapy for patients suffering with this rare condition, and we look forward to sharing the exciting clinical data at upcoming medical meetings. This new indication will add to our existing commercial hematology business of Omisirge® for hematologic malignancies and APHEXDA® for autologous transplantation.”

About Ayrmid Ltd. and Gamida Cell

Ayrmid Ltd. is the parent company of Gamida Cell Inc., a cell therapy pioneer working to turn cells into powerful therapeutics. The Company’s proprietary nicotinamide (“NAM”) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. Gamida Cell operates as a wholly owned subsidiary of Ayrmid Limited, a UK entity. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.

About Omisirge®

Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood and launched in 2023 under the brand name Omisirge®. Please see the current full Prescribing Information, including boxed warning, here.

About APHEXDA®

APHEXDA® (motixafortide) is a CXCR4 antagonist with long receptor occupancy (greater than 72 hours) that, in combination with filgrastim (G-CSF), enables mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma. Please see the current full Prescribing Information, including boxed warning, here.

Contacts

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