Omisirge transplantation shows accelerated immune recovery in SAA
New data presented at the 2026 TANDEM Meetings demonstrate that patients with SAA who received Omisirge experienced faster and more robust immune recovery compared with patients receiving alternative transplant graft sources
Omisirge approved by FDA as First Cell Therapy to Treat Severe Aplastic Anemia
Key Highlights of Data Presented at TANDEM:
Rapid neutrophil recovery: Median time to neutrophil engraftment was 10 days following Omisirge transplantation. Faster recovery was associated with higher transplanted CD34⁺ cell doses
Enhanced CD4⁺T-cell reconstitution: At six months post-transplant, CD4⁺ T-cell counts were significantly higher in Omisirge recipients compared with other transplant sources including matched and haploidentical donors. Higher CD4⁺ T-cell recovery correlated with more rapid neutrophil engraftment
Accelerated NK-cell recovery: Natural killer (NK) cell reconstitution occurred early after transplant, with median NK-cell counts at days 30 and 100 exceeding those observed across all comparator graft sources
Omisirge approved by the FDA on December 5, 2025 for SAA
DUBLIN, IE / ACCESS Newswire / February 5, 2026 / Ayrmid Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., a leader in cell therapy innovation, today announced further positive interim clinical results for Omisirge (Omidubicel-onlv), its advanced stem cell transplant therapy for Severe Aplastic Anemia (SAA). The data showed that patients with SAA who received Omisirge transplants experienced faster and more robust immune recovery compared with patients receiving other transplant graft sources, including HLA-matched donor peripheral blood stem cells, haploidentical donors with post-transplant cyclophosphamide, standard cord blood, and combined cord/haploidentical transplants. The findings come from an ongoing single-center Phase II study conducted at the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) and were presented by investigators from NHLBI/NIH and collaborating institutions at the 2026 Transplantation & Cellular Therapy meetings of ASTCT® and CIBMTR® (TANDEM), taking place from February 4-7, 2026 in Salt Lake City, UT.
Alternative donor hematopoietic cell transplantation (HCT) has historically been limited in SAA by delayed engraftment and high rates of graft rejection. Omisirge is a nicotinamide-expanded cord blood product designed to increase the number of hematopoietic stem and progenitor cells available for transplantation.
Dr. Richard Childs of the National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) commented: "In this study, we observed that Omisirge transplantation was associated with faster neutrophil engraftment and earlier recovery of key immune cell populations compared with historical transplant approaches in SAA. These findings suggest that enhanced stem cell dose may translate into improved early immune reconstitution in this high-risk patient population."
Dr. Ronit Simantov, Chief Medical and Scientific Officer of Ayrmid commented: "These results highlight the significant potential of Omisirge as a transplant option for patients with SAA. The enhanced immune recovery observed following Omisirge transplantation may have important clinical implications for patients with SAA, including improved engraftment, reduced risk of graft rejection, and potentially lower susceptibility to infections in the post-transplant period. We remain deeply committed to advancing transformative therapies for patients with serious unmet medical needs."
Omisirge is now approved for treatment in adults and pediatric patients 6 years of age and older with SAA following reduced intensity conditioning. The FDA approval of Omisirge was based on data from the 17-H-0091 study.
About Severe Aplastic Anemia
Severe Aplastic Anemia is a rare, life-threatening hematologic disorder in which the bone marrow fails to produce sufficient blood cells. Stem cell transplantation offers a potential cure; however, many patients lack a matched sibling donor. Ayrmid is advancing therapies to address this unmet medical need.
About Ayrmid Ltd. and Gamida Cell
Ayrmid Ltd. is the parent company of Gamida Cell Inc., a pioneering cell therapy company developing novel treatments designed to turn cells into powerful therapeutics. Gamida Cell Inc. currently has two FDA approved products on the market in the US, namely Omisirge® (please see the current full Prescribing Information, including boxed warning, here) and APHEXDA® (please see the current full Prescribing Information here). 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.
Contacts: Media, Investors / Business Development: bd@ayrmid.com
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SOURCE: Ayrmid Pharma Ltd
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